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Performing cardiac surgery on patients with bleeding diatheses poses significant challenges since these patients are at an increased risk for complications secondary to excessive bleeding. Despite its rarity, patients with factor VII (FVII) deficiency may require invasive procedures such as cardiac surgery. However, we lack guidelines on their pre-, peri-, and post-operative management. As FVII deficiency is rare, it seems unlikely to design and learn from large clinical studies. Instead, we need to base our clinical decision-making on single reported cases and registry data. Herein, we present the rare case of a patient with FVII deficiency who underwent double valve surgery. Pre-operatively, activated recombinant FVII (rFVIIa) was administered to reduce the risk of bleeding. Nevertheless, the patient experienced major bleeding. This case highlights the significance of FVII deficiency in patients undergoing cardiac surgery and emphasizes the importance of adequate and appropriate transfusion of blood products for these patients. [ABSTRACT FROM AUTHOR]

In this study, we investigated the feasibility of the Alberta Stroke Program Early CT Score (ASPECTS) and multiphase computed tomography angiography (mCTA) lateral branch circulation grading combined with clinical and laboratory indicators to predict the clinical prognosis of patients with acute ischemic stroke after 90 days. The clinical data of 80 patients with acute anterior circulation ischemic stroke were retrospectively analyzed and divided into the good prognosis (37 cases) and poor prognosis groups (43 cases) according to their clinical function score at 90 days after discharge. Various factors, including basic imaging parameters (ASPECTS), occluded vessel location, affected side location and clinical indicators (time from onset to computed tomography examination, height, weight, body mass index, previous hypertension, and degree of hypertension and diabetes mellitus), laboratory blood rutine, and biochemical tests (white blood count, neutrophil count, lymphocyte count, neutrophil-to-lymphocyte ratio, hematocrit test, platelet count, international normalized ratio, blood glucose, triglycerides, uric acid, and D-dimer) were considered in the analysis. Logistic regression analysis showed that the mCTA score, hypertension, and neutrophil count were significant independent predictors. A nomogram of the mCTA score, hypertension, and neutrophil count may predict functional recovery after 90 days in patients with acute ischemic stroke. • The worse the computed tomography angiography (CTA) collateral circulation, the poorer the prognosis for acute ischemic stroke (AIS) patients. • AIS patients with higher hypertension classification have poorer clinical prognosis. • Increase in neutrophil ratio will lead to a poor clinical prognosis for AIS patients. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate if implementation of the 2019 Society of Interventional Radiology (SIR) guidelines for periprocedural management of bleeding risk in patients undergoing percutaneous ultrasound guided liver biopsy is associated with increased haemorrhagic adverse events, change in pre-procedural blood product utilization, and evaluation of guideline compliance rate at a single academic institution. Methods: Ultrasound guided percutaneous liver biopsies from (January 2019-January 2023) were retrospectively reviewed (n = 504), comparing biopsies performed using the 2012 SIR pre-procedural coagulation guidelines (n = 266) to those after implementation of the 2019 SIR pre-procedural guidelines (n = 238). Demographic, preprocedural transfusion, laboratory, and clinical data were reviewed. Chart review was conducted to evaluate the incidence of major bleeding adverse events defined as those resulting in transfusion, embolization, surgery, or death. Results: Implementation of the 2019 SIR periprocedural guidelines resulted in reduced guideline non-compliance related to the administration of blood products, from 5.3% to 1.7% (P =.01). The rate of pre-procedural transfusion remained the same pre and post guidelines at 0.8%. There was no statistically significant change in the incidence of bleeding adverse events, 0.8% pre guidelines versus 0.4% post (P = 1.0). Conclusion: Implementation of the 2019 SIR guidelines for periprocedural management of bleeding risk in patients undergoing percutaneous ultrasound guided liver biopsy did not result in an increase in bleeding adverse events or pre-procedural transfusion rates. The guidelines can be safely implemented in clinical practice with no increase in major adverse events. [ABSTRACT FROM AUTHOR]

Objective To assess the outcome of patients with cancer-related sepsis requiring continuous renal replacement therapy (CRRT) in a single-center pediatric intensive care unit (PICU). Method Children with sepsis who necessitate CRRT from January 2017 to December 2021 were enrolled. The patients with leukemia/lymphoma or solid tumors were defined as underlying cancer. Multivariate logistic regression analysis was performed to identify the death risk factors in patients with cancer-related sepsis. Results A total of 146 patients were qualified for inclusion. Forty-six (31.5%) patients with cancer-related sepsis and 100 (68.5%) non-cancer-related sepsis. The overall PICU mortality was 28.1% (41/146), and mortality was significantly higher in cancer-related sepsis patients compared with non-cancer patients (41.3% vs. 22.0%, p = 0.016). Need mechanical ventilation, p-SOFA, acute liver failure, higher fluid overload at CRRT initiation, hypoalbuminemia, and high inotropic support were associated with PICU mortality in cancer-related sepsis patients. Moreover, levels of IL-6, total bilirubin, creatinine, blood urea nitrogen, and international normalized ratio were significantly higher in non-survivors than survivors. In multivariate logistic regression analysis, pediatric sequential organ failure assessment (p-SOFA) score (OR:1.805 [95%CI: 1.047–3.113]) and serum albumin level (OR: 0.758 [95%CI: 0.581 -0.988]) were death risk factors in cancer-related sepsis receiving CRRT, and the AUC of combined index of p-SOFA and albumin was 0.852 (95% CI: 0.730–0.974). Conclusion The overall PICU mortality is high in cancer-related sepsis necessitating CRRT. Higher p-SOFA and lower albumin were independent risk factors for PICU mortality. [ABSTRACT FROM AUTHOR]

Background: Atrial fibrillation is a growing epidemic in Africa. Anticoagulation, considered the backbone for non-valvular atrial fibrillation (NVAF) management, is limited to warfarin as the mainstay of available anticoagulation therapy in most low- and middle-income countries (LMIC). The optimal time in the therapeutic range (TTR) while on warfarin is essential to avoid bleeding and thromboembolic complications. This study assessed anticoagulation control in patients with NVAF on warfarin in Johannesburg, South Africa. Methods: We conducted a cross-sectional retrospective study on patients with NVAF managed in the Division of Cardiology, at a tertiary-level academic centre in Johannesburg, South Africa, between 1 January 2015 and 31 December 2019. Anticoagulation control for patients with NVAF was assessed by calculating the TTR using the Rosendaal method. Results: The study population comprised 177 patients diagnosed with NVAF. The mean age was 65.0 ± 13.1 years. The median TTR among patients with NVAF was 46% [interquartile range (IQR): 8.7–86.0], and 63 (35.6%) patients with NVAF had a TTR ≥ 70% (optimal anticoagulation control). Patients with poor anticoagulation control (TTR < 70%) were on warfarin for a shorter duration compared with those with optimal anticoagulation control [56 days (IQR: 43–84) vs. 70 days (IQR: 56–140), p = 0.0013]. The mean CHA2DS2-VASc score was 4 ± 1.5, and it did not differ between patients with poor or optimal anticoagulation control. Among the 175 patients with available HAS-BLED scores, 21 (12.0%), 112 (64.0%) and 42 (24.0%) were at a low, moderate, and high risk for bleeding, respectively. Of the 21 patients in the HAS BLED low-risk category, only 4 (19.0%) had a TTR < 70% (p < 0.001). Warfarin toxicity was documented in 13 (7.3%) patients. Conclusion: In our study, a TTR ≥ 70%, suggesting optimal anticoagulation control, was found in only 35.6% of patients with NVAF on warfarin. [ABSTRACT FROM AUTHOR]

Massive transfusion of blood products poses challenges in determining the need for transfusion and the appropriate volume of blood products. This review explores the use of machine learning (ML) models to predict transfusion risk during surgical procedure, focusing on the methodology, variables, and software employed to predict transfusion. This scoping review investigates the development and current state of machine learning models for predicting transfusion risk during surgical procedure, aiming to inform physicians about the field's progress and potential directions. The review was conducted using the databases Cochrane, Embase, and PubMed. The search included keywords related to blood transfusion, statistical models, and surgical procedures. Peer-reviewed articles were included, while literature reviews, case reports, and non-human studies were excluded. A total of 40 studies met the inclusion criteria. The most frequently studied biological variables included haemoglobin, platelet count, international normalized ratio (INR), activated partial thromboplastin time (aPTT), fibrinogen, creatinine, white blood cells, and albumin. Clinical variables of importance included age, sex, surgery type, blood pressure, weight, surgery duration, american society of anesthesiology (ASA) status, blood loss, and body mass index (BMI). The software employed varied, with Python, R, SPSS, and SAS being the most commonly used. Logistic regression was the predominant methodology used in 20 studies. Our scoping review highlights the need for improved reporting and transparency in methodology, variables, and software used. Future research should focus on providing detailed descriptions and open access to codes of respective models, promoting reproducibility, and enhancing the clinical relevance of transfusion risk prediction models. [ABSTRACT FROM AUTHOR]

This study aimed to ascertain how the current two ART regimens used in Ghana affected HIV patients' coagulation profiles. A case-control study was conducted on 102 HIV positive patients at the Mampong Municipal Hospital. Coagulation parameters measured showed APTT was normal in majority of ART-experienced participants but prolonged in majority of ART-naïve participants. The mean platelet count was significantly higher in ART-experienced participants. No significant differences were found between the coagulation profiles of ART-experienced patients on two different drug regimens. In conclusion, current ART can enhance the coagulation profiles in HIV-infected patients, by improving platelet count and APTT. [ABSTRACT FROM AUTHOR]

This study aimed to identify predictive factors for the prognosis of acute-on-chronic liver disease (AoCLD) due to both hepatitis B virus (HBV) and alcohol and to develop prognostic models to improve treatment management. AoCLD patients with HBV and alcohol as etiological factors were selected from two multicenter prospective cohorts (NCT02457637,NCT03641872) and included in separate training and validation cohorts (n = 180 and n = 148). In the training cohort, the CATCH-LIFE A nomogram (based on age, bilirubin, international normalized ratio, serum sodium, and hepatic encephalopathy score) and CATCH-LIFE B nomogram (based on age, bilirubin, international normalized ratio, serum albumin, white blood cell, platelet count, and hepatic encephalopathy score) had discriminatory ability for predicting 28-day (c-indexes of 0.910 and 0.899) and 90-day mortality (c-indexes of 0.878 and 0.887, respectively). The area under the curve values for 28-day and 90-day mortality prediction by the CATCH-LIFE A nomogram were 0.922 (95% CI : 0.874, 0.971) and 0.905 (0.856, 0.956), respectively, while those for the CATCH-LIFE B nomogram were 0.916(0.861,0.972) and 0.915 (0.866,0.964), respectively. Similar performance results were observed in the validation cohort. Optimal cut-off scores for each nomogram could be used for patient stratification in high- and low-risk groups, and the high-risk groups showed shorter survival times than the low-risk groups in both the training and validation cohorts. Two nomograms constructed from the first short-term follow-up data from patients with AoCLD due to combined HBV infection and alcohol exposure showed good predictive performance for 28-day and 90-day mortality and might be used to guide clinical management. [ABSTRACT FROM AUTHOR]

Introduction Methods Results Conclusion Real‐world studies comparing safety and efficacy of combined percutaneous left atrial appendage occlusion (LAAO) and catheter ablation (CA) to LAAO alone are limited.Patients from a large US hospital system undergoing combined LAAO and left‐atrial CA from 8/2020 to 2/2024 were retrospectively analyzed and compared to a control group undergoing LAAO alone. Controls were identified using a 1:2 propensity score match based on LAAO device type (Watchman FLX vs. Amulet), CHA2D2‐VASc and Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio [INR], Elderly, Drugs/alcohol (HAS‐BLED) scores and compared for safety, sealing performance and clinical outcomes at 6 months.Patients were younger in the combined (n = 72) than in the control group (n = 144, 70.2 ± 7.3 vs. 76.7 ± 6.9 years, p < 0.001) but otherwise comparable with a mean CHA2D2‐VASc score of 4.2 ± 1.1 and 4.4 ± 1.2 (p = 0.26) and HAS‐BLED score of 2.2 ± 0.8 and 2.3 ± 0.7 (p = 0.34). Successful LAAO implantation rates were the same (95.8% vs. 95.8%, p = 0.99) with longer procedure times seen in the combined group (156.5 ± 53 vs. 56 ± 26 min, p < 0.001). Both major (1.4% vs. 2.1%, p = 0.72) and minor (27.8% vs. 19.4%, p = 0.17) in‐hospital complications were similar between the combined and control group, respectively. At 45 days, presence of peri‐device leak (18.3% vs. 30.4%, p = 0.07) and device related thrombosis (4.5% vs. 4.5%, p = 0.96) on transesophageal echocardiogram did not differ. Finally, all‐cause mortality (0% vs. 1.4%, p = 0.99), thromboembolic (0% vs. 0%, p = 0.99) and bleeding (6.1% vs. 4.4%, p = 0.73) events during follow‐up were comparable.This large, real‐world analysis indicates comparable safety and efficiency of combined LAAO and CA when compared with LAAO alone. [ABSTRACT FROM AUTHOR]

Background Methods Results Discussion Despite prophylactic platelet transfusions, hypoproliferative thrombocytopenia is associated with bleeding; historical risk factors include hematocrit (HCT) ≤$$ \le $$25%, activated partial thromboplastin time ≥$$ \ge $$30 s, international normalized ratio ≥$$ \ge $$1.2, and platelets≤$$ \le $$5000/μL.We performed a post hoc analysis of bleeding outcomes and risk factors in participants with hematologic malignancy and hypoproliferative thrombocytopenia enrolled in the American Trial to Evaluate Tranexamic Acid Therapy in Thrombocytopenia (A‐TREAT) and randomized to receive either tranexamic acid (TXA) or placebo.World Health Organization (WHO) grade 2+ bleeding occurred in 46% of 330 participants, with no difference between the TXA (44%) and placebo (47%) groups (p = 0.66). Overall, the most common sites of bleeding were oronasal (18%), skin (17%), gastrointestinal (11%), and genitourinary (11%). Among participants of childbearing potential, 28% experienced vaginal bleeding. Platelets ≤5000/μL and HCT < 21% (after adjusting for severe thrombocytopenia) were independently associated with increased bleeding risk (HR 3.78, 95% CI 2.16–6.61; HR 2.67, 95% CI 1.35–5.27, respectively). Allogeneic stem cell transplant was associated with nonsignificant increased risk of bleeding versus chemotherapy alone (HR 1.34, 95% CI 0.94–1.91).The overall rate of WHO grade 2+ bleeding was similar to previous reports, albeit with lower rates of gastrointestinal bleeding. Vaginal bleeding was common in participants of childbearing potential. Platelets ≤5000/μL remained a risk factor for bleeding. Regardless of platelet count, bleeding risk increased with HCT < 21%, suggesting a red blood cell transfusion threshold above 21% should be considered to mitigate bleeding. More investigation is needed on strategies to reduce bleeding in this population. [ABSTRACT FROM AUTHOR]

It is common practice in laboratories to store biological samples in ultra-low temperature (ULT) freezers. There is growing interest in raising the temperature of ULT freezers in order to save energy and reduce expenses, as energy conservation becomes increasingly important and sustainable laboratory practices gain popularity. In our laboratory, plasma samples are stored for three months for diagnostic purposes. We therefore took the opportunity to investigate the effect of two different storage temperatures (−70 °C vs −80 °C), on activated partial thromboplastin time (APTT), factor VIII (FVIII), international normalized ratio (INR) and factor VII (FVII) measurements on paired plasma samples collected from 26 individuals after three months of storage. Automated coagulation analysers CS-5100 and ACL TOP were used to perform the tests. We found no consistent difference between the two storage temperatures for any of the four coagulation parameters (all p-values > 0.05). We conclude that the temperature of ULT freezers used to store plasma samples for APTT, FVIII, INR, and FVII measurements can be safely increased from −80 to −70 °C without affecting the stability of the samples. [ABSTRACT FROM AUTHOR]

Objectives To evaluate the utility of the dilute prothrombin time (DPT) in diagnosing antiphospholipid syndrome (APS), alone and when paired with the dilute Russell viper venom time (DRVVT). Methods Dilute prothrombin time and DRVVT testing was performed on plasma samples spiked with apixaban or rivaroxaban, or depleted of vitamin K–dependent clotting factors. A retrospective analysis of all functional APS testing results over a 44-month period at the University of Chicago Medical Center was performed. Results In spiking studies, the screening clotting time in the DPT (DPTS) is more sensitive to deficiency of vitamin K–dependent factors than is the screening clotting time in the DRVVT (DRVVTS). The converse is true for factor Xa direct oral anticoagulant (DOAC)–spiked plasma. In a 44-month retrospective analysis, only 2.6% of clinical APS panels showed isolated positivity in the DPT-based system. Comparing the DPT-based system with the DRVVT-based system showed utility in identifying false-positive DRVVT results due to anticoagulation. A DRVVTS/DPTS ratio of 0.785 or lower predicted an international normalized ratio of 1.5 or higher (sensitivity, 86.3%; specificity, 60.4%; likelihood ratio, 2.18). Conversely, a DRVVTS/DPTS ratio of 1.165 or higher was the optimal cutoff for predicting the identification of factor Xa DOAC (sensitivity, 61.8%; specificity, 77.8%; likelihood ratio, 2.78). Within the data set that had full DRVVT and DPT results, parameters were identified that could further improve identification of samples with anticoagulation interference. Conclusions Dilute prothrombin time lupus anticoagulant assay is rarely the sole laboratory functional evidence for APS, but when combined with the DRVVT, the DPT can serve as an effective screen for common anticoagulant interference. [ABSTRACT FROM AUTHOR]

Background/Objectives: Multi-organ failure (MOF) often complicates advanced heart failure (HF), contributing to a poor prognosis. The Model of End-Stage Liver Disease 3.0 (MELD-3.0) scale incorporates liver and kidney function parameters. This study aims to evaluate the prognostic significance of the MELD-3.0 score in patients with advanced HF who have undergone heart transplantation (HTx). Methods: The MELD-3.0 score was computed using the average values of the international normalized ratio and bilirubin, creatinine, sodium, and albumin levels during a hospital stay following HTx. The average MELD-3.0 scores from the period of 1 month preceding HTx and 1 week after HTx were analyzed. The primary endpoint of the study was the 6-month total mortality, and the secondary endpoint was ICU hospitalization time after HTx. Results: The analysis included 106 patients undergoing HTx, with a median age of 53 years (44–63), 81% of whom were male. Within 6 months post-HTx, 17 patients (16%) died; those patients had a higher 1-week post-HTx MELD-3.0 score of 18.3 (14.5–22.7) in comparison to survivors, whose average score was 13.9 (9.5–16.4), p < 0.01. There was no difference in MELD 3.0 score in the pre-HTx period: 16.6 (11.4–17.8) vs. 12.3 (8.6–17.1), p = 0.36. The post-HTx MELD-3.0 score independently predicted death: RR 1.17 (95% CI 1.05–1.30), p < 0.01. A Receiver Operating Characteristic (ROC) determined the cut-off value of the MELD-3.0 score as 17.3 (AUC = 0.83; sensitivity—67%; specificity—86%). Survivors with scores above this value had a longer ICU hospitalization time: 7 (5.0–11.0) vs. 12 (8–20) days (p = 0.01). Conclusions: The post-HTx MELD-3.0 score serves as an independent predictor of an unfavorable prognosis in patients with advanced HF undergoing HTx. The evaluation of MELD-3.0 scores provides additional prognostic information in this population. [ABSTRACT FROM AUTHOR]

The ability of the SARS-CoV-2 virus to cause DNA damage in infected humans requires its study as a potential indicator of COVID-19 progression. DNA damage was studied in leukocytes of 65 COVID-19 patients stratified by sex, age, and disease severity in relation to demographic, clinical, and laboratory parameters. In a combined group of COVID-19 patients, DNA damage was shown to be elevated compared to controls (12.44% vs. 5.09%, p < 0.05). Severe cases showed higher DNA damage than moderate cases (14.66% vs. 10.65%, p < 0.05), and males displayed more damage than females (13.45% vs. 8.15%, p < 0.05). DNA damage is also correlated with international normalized ratio (INR) (r = 0.471, p < 0.001) and creatinine (r = 0.326, p < 0.05). In addition to DNA damage, severe COVID-19 is associated with age, C-reactive protein (CRP), and creatinine. Receiver operating characteristic analysis identified age, INR, creatinine, DNA damage, and CRP as significant predictors of disease severity, with cut-off values of 72.50 years, 1.46 s, 78.0 µmol/L, 9.72%, and 50.0 mg/L, respectively. The results show that DNA damage correlates with commonly accepted COVID-19 risk factors. These findings underscore the potential of DNA damage as a biomarker for COVID-19 severity, suggesting its inclusion in prognostic assessments to facilitate early intervention and improve patient outcomes. [ABSTRACT FROM AUTHOR]

The article explores the model for end-stage liver disease (MELD) score and its role in predicting mortality for patients awaiting liver transplantation. It discusses the limitations of the current MELD score due to changes in chronic liver disease and introduces a new scoring system called MELD 3.0. This updated system aims to better predict waitlist mortality and address healthcare disparities among underrepresented candidates. The article also addresses the disparity in waitlist mortality rates between men and women, highlighting factors such as kidney function underestimation and organ size limitations for women. It suggests that future iterations of the MELD system may address these issues and mentions the potential use of large language models and machine learning in improving waitlist mortality prediction and organ allocation. [Extracted from the article]

Objectives: To determine whether international normalized ratio (INR), bilirubin, and creatinine predict bleeding risk following percutaneous liver biopsy. Methods: A total of 870 consecutive patients (age 53 ± 14 years; 53% (459/870) male) undergoing non-targeted, ultrasound-guided, percutaneous liver biopsy at a single tertiary center from 01/2016 to 12/2019 were retrospectively reviewed. Results were analyzed using descriptive statistics and logistic regression models to evaluate the relationship between individual and combined laboratory values, and post-biopsy bleeding risk. Receiver operating characteristic (ROC) curves and area under ROC (AUC) curves were constructed to evaluate predictive ability. Results: Post-biopsy bleeding occurred in 2.0% (17/870) of patients, with 0.8% (7/870) requiring intervention. The highest INR within 3 months preceding biopsy demonstrated the best predictive ability for post-biopsy bleeding and was superior to the most recent INR (AUC = 0.79 vs 0.61, p = 0.003). Total bilirubin is an independent predictor of bleeding (AUC = 0.73) and better than the most recent INR (0.61). Multivariate regression analysis of the highest INR and total bilirubin together yielded no improvement in predictive performance compared to INR alone (0.80 vs 0.79). The MELD score calculated using the highest INR (AUC = 0.79) and most recent INR (AUC = 0.74) were similar in their predictive performance. Creatinine is a poor predictor of bleeding (AUC = 0.61). Threshold analyses demonstrate an INR of > 1.8 to have the highest predictive accuracy for bleeding. Conclusion: The highest INR in 3 months preceding ultrasound-guided percutaneous liver biopsy is associated with, and a better predictor for, post-procedural bleeding than the most recent INR and should be considered in patient risk stratification. Clinical relevance statement: Despite correction of coagulopathic indices, the highest international normalized ratio within the 3 months preceding percutaneous liver biopsy is associated with, and a better predictor for, bleeding and should considered in clinical decision-making and determining biopsy approach. Key Points: • Bleeding occurred in 2% of patients following ultrasound-guided liver biopsy, and was non-trivial in 41% of those patients who needed additional intervention and had an associated 23% 30-day mortality rate. • The highest INR within 3 months preceding biopsy (AUC = 0.79) is a better predictor of bleeding than the most recent INR (AUC = 0.61). • The MELD score is associated with post-procedural bleeding, but with variable predictive performance largely driven by its individual laboratory components. [ABSTRACT FROM AUTHOR]

Introduction: The transition to or from direct oral anticoagulants (DOACs) is common in clinical practice. Areas covered: A literature search was conducted on PubMed, Google Scholar, and UpToDate up to March 2024 for conditions and approaches for transitioning from one agent to the other. No randomized clinical trials were retrieved except for two studies regarding switching to DOAC in well-conducted vitamin K antagonist (VKA) therapy. A narrative review was conducted addressing the conditions for switching from one agent to the other, such as thromboembolic events and major bleeding during anticoagulation, development or worsening of kidney or liver failure, initiation of interfering drugs, adverse events such as allergic reactions, frailty, patients' preferences, and affordability. During transitions from one anticoagulant to the other, the risk of both thromboembolic and bleeding complications should be minimized. The current approaches for such transitions are derived from those employed in clinical trials evaluating DOAC and from product information. Expert opinion: Many uncertainties remain regarding those circumstances requiring a change in anticoagulant strategies, as they lack evidence-based guidance. It can be envisaged that the problem of switching to and from DOAC will need additional studies especially addressing the conditions and the best approach to such transitions. [ABSTRACT FROM AUTHOR]

Background: This study aimed to investigate the roles of cytokines and other laboratory parameters in determining the need for intensive care in COVID-19 patients. Methods: This is a retrospective observational study. Demographic, clinical, and laboratory parameters of the patients were evaluated. Thirteen cytokines were measured along with baseline laboratory tests at admission and at 48-hour intervals: IL-1β, IFN-α, IFN-β, TNF-α, MCP-1, IL-6, IL -8, IL-10, IL-2p70, IL-17A, IL-18, IL-23, and IL- 33. Results: COVID-19 was confirmed by PCR in 116 hospitalized patients. The mean age was 55.3 ± 16.4 years. Seventy- four (63.8%) of the patients were male and 42 (36.2%) were female. Twenty-two (18.9%) patients (16 male, 6 female) were transferred to the intensive care unit. A significant increase in white blood cell (WBC), neutrophil (Neu) and lymphocyte (Lym) counts, Neu/Lym ratio (NLR), lactate dehydrogenase (LDH), INR (international normalized ratio), activated prothrombin time (aPTT), D-dimer (D-D), troponin (Trop), Pro-BNP (BNP), procalcitonin (PCT), ferritin (Fer), and alanine aminotransferase (ALT) values were observed in those requiring intensive care. A significant decrease was found in albumin (Alb) levels and Lym counts. Alb levels appeared to be protective against admission to intensive care. Except for IFN- α, IL-23, and IL-33, the baseline values of other cytokines were above the threshold values. MCP-1 and IL-6 were higher in patients requiring intensive care. Conclusions: High NLR and LDH and low Alb levels, especially with an increase in MCP-1 and IL-6, were found to be the best predictors of a serious COVID-19 infection. [ABSTRACT FROM AUTHOR]

Endovascular treatment (EVT) has been proven to be the standard treatment for acute vertebrobasilar artery occlusion (VBAO). This study aimed to analyze the effects of international normalized ratio (INR) indicators on outcomes in patients with acute VBAO treated with EVT. Dynamic data on INR in patients with VBAO who received endovascular treatment (EVT) at 65 stroke centers in China were retrospectively enrolled. Outcome measures included the modified Rankin Scale (mRS) score at 90 days and 1 year and symptomatic intracranial hemorrhage (sICH). The associations between elevated INR (INR > 1.1), INR variability (time-weighted variance of INR changes), and various clinical outcomes were analyzed in all patients and subgroups stratified by oral anticoagulation (OAC) by mixed logistic regression analysis. A total of 1825 patients met the study criteria, of which 1384 had normal INR and 441 had elevated INR. Multivariate analysis showed that elevated INR was significantly associated with poor functional outcomes (mRS 4–6) at 90 days (odds ratio [OR] 1.36, 95% confidence interval [CI] 1.08–1.72) and 1 year (OR 1.32, 95% CI 1.05–1.66), but was not associated with an increased risk of sICH (OR 1.00, 95% CI 0.83–1.20). Similar associations exist between INR variability and poor functional outcomes at 90 days (OR 2.17, 95% CI 1.09–4.30), 1 year (OR 2.28, 95% CI 1.16–4.46), and sICH (OR 1.11, 95% CI 0.93–1.33). Subgroup analyses further revealed that elevated INR and INR variability remained associated with poor functional outcomes in patients not receiving oral anticoagulation (OAC) therapy, while no significant associations were observed in OAC-treated patients, regardless of whether they were on warfarin or direct oral anticoagulants. Elevated INR and INR variability in VBAO patients treated with EVT were associated with poor functional outcomes. The mechanism underlying the association between elevated INR and poor functional outcomes might be attributed to the fact that elevated INR indirectly reflects the burden of comorbidities, which could independently worsen outcomes. These findings underscore the importance of a comprehensive and dynamic evaluation of INR levels in the management of VBAO patients receiving EVT, providing valuable insights for optimizing patient outcomes. [ABSTRACT FROM AUTHOR]

Objective: To investigate the diagnostic value of ultrasound elastography combined with aspartate aminotransferase to platelet ratio index (APRI), international normalized ratio/platelet ratio (INPR), and four-factor-based liver fibrosis index (FIB-4) for liver fibrosis in patients with autoimmune hepatitis (AIH). Methods: 120 AIH patients who were admitted to our hospital from January 2021 to December 2022 underwent liver biopsy and the patients were divided into significant liver fibrosis group (F2-F4, n=74) and non-significant liver fibrosis group (F0-F1, n=46) according to the Metavir evaluation system, the baseline data, ultrasound elastography shear wave velocity (SWV), FIB-4, APRI and INPR were compared between the two groups. Logistic regression was used to analyze the influencing factors of significant liver fibrosis in AIH patients. The diagnostic value of SWV combined with APRI, INPR and FIB-4 for significant liver fibrosis in AIH patients were evaluated by receiver operating characteristic (ROC) curve. Results: The biopsy results of 120 AIH patients showed that: there were 15 cases (12.50%) in F0 stage, there were 31 cases (25.83%) in F1 stage, there were 35 cases (29.17%) in F2 stage, there were 27 cases (22.50%) in F3 stage, there were 12 cases (10.00%) in F4 stage. Compared with non-significant liver fibrosis group, the INR, SWV, APRI, INPR and FIB-4 values of the patients in the significant liver fibrosis group increased, and the PLT level decreased, with statistically significant differences (P<0.05). Logistic regression analysis showed that, elevated INPR, APRI, FIB-4 and SWV were risk factors for significant liver fibrosis in AIH (P<0.05). The results of ROC curve showed that, the AUC of APRI, INPR, FIB-4 and SWV in diagnosing the degree of liver fibrosis in AIH patients was>0.700, and the combination of the four items had the highest diagnostic efficiency. Conclusion: Ultrasound electrography parameters SWV combined with APRI, INPR and FIB-4 have high diagnostic value for significant liver fibrosis in AIH patients. [ABSTRACT FROM AUTHOR]

Objective: To investigate the risk factors for deep vein thrombosis (DVT) following total hip arthroplasty (THA). Methods: Patients who underwent THA in the Department of Joint Surgery at the Sixth Affiliated Hospital of Xinjiang Medical University from September 2020 to December 2022 were retrospectively selected based on inclusion criteria. They were divided into the DVT group (n = 65) and the non-DVT group (n = 397) according to the occurrence of postoperative DVT. The following variables were reviewed for both groups: age, sex, Body Mass Index (BMI), affected limb, previous history (smoking and drinking), diabetes, hypertension, operation time, total cholesterol, triglycerides, fibrinogen, hemoglobin, albumin, platelets, D-dimer, International Normalized Ratio (INR), and fibrin degradation products. Univariate analysis was conducted on these factors, and those with statistical significance were further analyzed using a binary logistic regression model to assess their correlation with DVT after THA. Results: A total of 462 patients were included in the study, with the DVT group representing approximately 14% and the non-DVT group approximately 86%. The DVT group had an average age of 67.27 ± 4.10 years, while the non-DVT group had an average age of 66.72 ± 8.69 years. Univariate analysis revealed significant differences in diabetes mellitus, preoperative fibrinogen, preoperative D-dimer, preoperative INR, and preoperative and postoperative fibrin degradation products between the DVT and non-DVT groups. Binary logistic regression analysis identified diabetes mellitus, elevated preoperative fibrinogen, preoperative D-dimer, and preoperative INR (p < 0.05) as risk factors for DVT after THA. Conclusion: This study found that diabetes mellitus, elevated preoperative fibrinogen, preoperative D-dimer, and preoperative INR are independent risk factors for DVT following THA. Surgeons should thoroughly assess these risk factors, implement timely and effective interventions, and guide patients to engage in functional exercises as early as possible to reduce the incidence of DVT, thereby improving the outcomes of THA and improving patient quality of life. [ABSTRACT FROM AUTHOR]

Introduction: Current guidelines recommend that the International Normalized Ratio (INR) be less than 1.5 prior to spine intervention. Recent studies have shown that an INR > 1.25 is associated worse outcomes following anterior cervical surgery. We sought to determine the risk of complications associated with an INR > 1.25 following elective posterior cervical surgery. Methods: The American College of Surgeons National Surgical Quality Improvement Program database was queried. Patients undergoing elective posterior cervical surgery from 2012 to 2016 with an INR level within 24 h of surgery were included. Primary outcomes were hematoma requiring surgery, 30-day mortality, and transfusions within 72-hours. There were 815 patients in the INR ≤ 1 cohort (Cohort A), 410 patients in the 1 < INR ≤ 1.25 cohort (Cohort B), and 33 patients in the 1.25 < INR ≤ 1.5 cohort (Cohort C). Results: Cohort C had a higher rate of transfusion (4% Cohort A; 6% Cohort B; 12% Cohort C; p = 0.028) and the rate of mortality within 30 days postoperatively trended toward significance (0.4% Cohort A; 0.5% Cohort B; 3% Cohort C; p = 0.094). There was no significant difference in the rate of postoperative hematoma formation requiring surgery (0.2% Cohort A; 0% Cohort B; 0% Cohort C; p = 0.58). On multivariate analysis, increasing INR was not associated with an increased risk of developing a major complication. Conclusion: An INR > 1.25 but ≤ 1.5 may be safe for posterior cervical surgery. An INR > 1.25 but ≤ 1.5 was associated with a significantly higher rate of transfusions. However, increasing INR was not significantly associated with increased risk of any of the major complications. [ABSTRACT FROM AUTHOR]

Introduction: Coronavirus disease 2019 (COVID-19) patients are predisposed to thrombotic events. COVID-19 coagulopathy can be associated with ADAMTS-13 (a disintegrin-like and metalloprotease with thrombospondin type I repeats 13) levels. ADAMTS-13, the cleaving protease of highly thrombogenic ultra-large von Willebrand Factor (vWF) multimers, was rarely investigated in COVID-19 patients and inconsistent results were obtained. We measured ADAMTS-13 levels of patients admitted to emergency department. Methodology: A prospective study was carried out with 180 individuals at the Emergency Department of Uşak Training and Research Hospital. The patients were divided into three groups: mild COVID-19 (group 2), severe COVID-19 with oxygen saturation below 94% (group 3), and control group (group 1). ADAMTS-13 levels were analyzed with an enzyme linked immunosorbent assay (ELISA) kit (SunRed, Shanghai, China). Demographic data, clinical findings, and routine laboratory test results (alanine aminotransferase (ALT), aspartate aminotransferase (AST), white blood cell, lymphocyte, platelet, C-reactive protein (CRP), lactate dehydrogenase (LDH), prothrombin time, international normalized ratio (INR), partial thromboplastin time, D-dimer, creatinine, urea) were evaluated. Results: ADAMTS-13 serum levels were slightly lower in groups 2 and 3 compared to the control group, with no significant difference between the ADAMTS-13 median values (p > 0.05). Groups 1 and 2 exhibited comparable outcomes. Group 3 demonstrated notably elevated levels of CRP, LDH, D-dimer, AST, ALT, creatinine; and decreased platelet counts and INR levels (p < 0.05). Conclusions: COVID-19-associated coagulopathy is still unclear. Based on our data, ADAMTS-13 levels cannot be used as a biomarker to help stratify patients' risks at the time of admission. [ABSTRACT FROM AUTHOR]

Catatrophic antiphospholipid syndrome (CAPS), a rare variant of antiphospholipid syndrome (APS), is associated with rapid multiorgan failure. While APS is associated with single medium-to-large blood vessel occlusions, CAPS is most often associated with several, concurrent vascular occlusions of small vessels, commonly of the kidneys, heart, skin and brain. We present a case of a 21-year-old female patient with a history of immune thrombocytopenia purpura and APS, who eventually developed concurrent cerebral venous sinus thrombosis, diffuse alveolar haemorrhage, renal thrombotic microangiopathy, and a necrotic, vasculitic wound on her forearm. Despite hospitalisation and treatment, her condition worsened and the patient eventually died after succumbing to suspected CAPS. [ABSTRACT FROM AUTHOR]

Objective: A large proportion of neonatal deaths not related to congenital anomalies are attributed to preterm births. The aim of this study was to compare the coagulation parameters in pregnant women with premature uterine contractions (PUC) who have preterm births with those who have term births and to determine the role of these coagulation parameters in predicting preterm delivery. Methods: Seventy-two pregnant women with PUC who applied to the Department of Obstetrics and Gynecology at the Okmeydanı Training and Research Hospital, University of Health Sciences, were included in the study. The coagulation parameters of 36 women who had preterm births were compared with those of 36 women who had term births. In analysing the findings of the study, statistical analyses were performed using IBM SPSS Statistics 22 (IBM SPSS, Turkey). The data were analyzed using Shapiro-Wilks, one-way, ANOVA, Tamhane's T2 test, and Student's t-test etc. Results: The activated partial thromboplastin time (aPTT) was significantly shorter in the preterm birth group (25.64±3.24 seconds) compared to the term birth group (26.153±2.49 seconds). International normalized ratio (INR) and prothrombin time (PT) levels were similar in both groups and subgroups. Fibrinogen levels were lower in the preterm birth group (397.56±54.67 mg/dL) compared to those who delivered at term (409.78±65.06 mg/dL). Fibrinogen levels were significantly lower in the preterm labor subgroup (388±50.72 mg/dL) compared to the preterm premature rupture of membranes (PPROM) subgroup (431±58.09 mg/dL). Conclusion: In this study, it was observed that the aPTT values in the preterm birth group were significantly shorter compared to the term birth group. Fibrinogen levels were found to be lower in the preterm birth group compared to those who delivered at term. Within the preterm labour subgroup, fibrinogen levels were significantly lower than those in the PPROM subgroup. INR and PT levels were similar across both groups and subgroups. The aPTT values were also similar between the preterm labour and PPROM subgroups. [ABSTRACT FROM AUTHOR]

Despite a higher safety profile compared to vitamin K antagonists, rivaroxaban therapy is still connected with multiple adverse effects, such as a high risk of bleeding. Thus, therapeutic drug monitoring (TDM) of rivaroxaban concentrations is suggested. An alternative to plasma samples can be dried blood spots (DBS), which minimize the cost of sample storage and transport. In this study, we developed a UPLC-MS/MS method for the analysis of rivaroxaban in DBS and plasma samples. Chromatographic separation was achieved on a Zorbax Eclipse Plus C18 column (2.1 × 100 mm; 3.5 µm, Agilent Technologies Inc., Santa Clara, CA, USA) with a mobile phase consisting of water and acetonitrile, both containing 0.1% formic acid. The analytes were detected using a positive ionization mode by multiple reaction monitoring. We validated the method according to ICH guidelines. The precision and accuracy were satisfactory. Extraction recovery was approximately 57% and 66% for DBS and plasma samples, respectively. A high correlation between rivaroxaban concentrations in plasma and DBS samples collected from patients was confirmed with Deming regression. The suitability of both sampling techniques for the rivaroxaban TDM was also verified by Bland–Altman plots based on DBS-predicted and observed plasma concentrations. In addition, we found a significant relationship between rivaroxaban concentrations and coagulation parameters, including prothrombin time (PT) and international normalized ratio (INR). [ABSTRACT FROM AUTHOR]

Hereditary factor VII (FVII) deficiency is an uncommon autosomal recessive disorder associated with mutations in the F7 gene, and laboratory investigations usually reveal isolated prolongation in prothrombin time (PT)/international normalized ratio (INR). Venom-induced consumptive coagulopathy (VICC) is distinguished by the activation of the coagulation pathway, which is triggered by procoagulant toxins in snake venom. Diagnosing snakebites in patients with hereditary FVII deficiency presents a challenge because prolonged time PT/INR is considered the most valuable diagnostic method for VICC. Therefore, it is possible that certain patients may not promptly receive an accurate diagnosis of hereditary FVII deficiency. We present a pedigree featuring hereditary FVII deficiency, which was diagnosed through Sanger sequencing, following a bamboo leaf green snake bite. [ABSTRACT FROM AUTHOR]

Objectives To present a new method for displaying blood utilization data based on analysis of decision time intervals (DTIs). Methods Retrospective study of patients treated in a medical intensive care unit (ICU), surgical ICU, or postcardiac surgery ICU at an academic hospital between January 2018 and June 2023. Each patient's episode of care was divided into a series of DTIs. Transfusions during each time interval were recorded. Results In total, 16,562 patients received 6980 units of plasma and 21,034 units of red blood cells during 111,557 time intervals of care. Patients had international normalized ratio (INR) values ranging from less than 1.0 to more than 4.0. Data on plasma transfusion at different INR values were displayed as the number of transfusion episodes, number of units given, or the proportion of DTIs with transfusion. Clinicians transfused plasma on 1.5% of occasions when the INR was 1.5 or less and on 2.2% of occasions when the INR was less than 2.0. Plasma was transfused without red blood cells in only 0.75% of DTIs. Transfusion practice was statistically different among the 3 ICUs. Conclusions Compared with traditional methods of displaying the results of blood audits, DTI analysis displays information regarding the decision both to transfuse and to not transfuse. Utilization reviews that display data based on decision time analysis reveal clinical practice patterns very different from those suggested by traditional displays of plasma audit data. [ABSTRACT FROM AUTHOR]

Introduction: We previously conducted a prospective, observational post-marketing surveillance study to assess the safety and effectiveness of four-factor prothrombin complex concentrate (4F-PCC) for rapid vitamin K antagonist (VKA) reversal in Japanese patients. Methods: This subgroup analysis compared the safety, especially thromboembolic events (TEEs), and effectiveness of 4F-PCC by stratifying patients into two subgroups according to baseline international normalized ratio (INR) levels with < 2.0 and ≥ 2.0. Results: Of 1271 eligible patients, 215 (17.9%) had INR < 2.0 and 987 (82.1%) had INR ≥ 2.0. Overall baseline characteristics were similar between groups; age (74.0 years vs 74.0 years), body mass index (22.1 kg/m2 vs 21.9 kg/m2), ratio of inpatients (90.2% vs 88.7%), manifested atrial fibrillation (46.0% vs 48.8%). Median INRs at baseline were 1.72 (minimum 0.92, maximum 1.99) in the INR < 2.0 group and 2.95 (2.00, 27.11) in the INR ≥ 2.0 group. The most common reason for 4F-PCC administration was intracranial hemorrhage (67.0% vs 59.5%), and lesser gastrointestinal bleeding (0.9% vs 7.5%). After 4F-PCC administration (average doses 24.5 IU/kg [INR < 2.0 group] and 29.2 IU/kg [INR ≥ 2.0 group]), INRs were significantly reduced to 1.21 (− 28%) and 1.31 (− 68%), respectively, and resulted in hemostasis in a similarly rapid manner. The incidences of adverse drug reactions were 3.7% in each group. TEEs occurred in 4 (1.9%) patients in the INR < 2.0 group and 11 (1.1%) patients in the INR ≥ 2.0 group and were predominantly composed of stroke, while similar rates (67.0% vs 62.9%) of bleeding events post-anticoagulant resumption were observed between groups. Conclusion: This study supports the favorable tolerability and efficacy of 4F-PCC regardless of baseline INR (< 2.0 or ≥ 2.0), with a prompt reduction of INR and substantial hemostatic effectiveness in the real-world setting for patients requiring urgent VKA reversal, although no indicated 4F-PCC dose for VKA reversal exists for INR < 2.0 to date. [ABSTRACT FROM AUTHOR]

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Background: Rational usage of blood components is important to ensure their availability to needy patients and to avoid unnecessary risk. Despite available guidelines, improvement in quality control, and standardization about the use of fresh frozen plasma (FFP), many studies around the world show a high frequency of its inappropriate use. Aims and Objectives: (i) To evaluate the pattern of FFP usage in our hospital and to categorize usage as appropriate or inappropriate based on FFP transfusion guidelines. (ii) To evaluate the effectiveness of FFP transfusion based on pre- and post-transfusion international normalized ratio (INR) values by calculating P-value using a paired t-test. Materials and Methods: This retrospective observational study was done by retrieving requisition forms of all the patients who received FFP transfusion in Tezpur Medical College, Tezpur, Assam, during the period of 2 years (November 01, 2020--October 31, 2022). Patients who received other blood products along with FFP were excluded from this study. Results: 1420 units of FFP were supplied to 850 patients during the study period of which 64% went to males. The most common age group receiving FFP was 30-39 years (28%). The most common indication for FFP was liver disease (33%). Appropriate usage was found in 74% of episodes and inappropriate usage in 26% of episodes. Statistically significant improvement was seen in post-transfusion INR when usage was appropriate (P < 0.001). Conclusion: The study highlighted the pattern of FFP usage in various clinical settings. Regular screening of requisition forms for proper guidelines-based indications, administrative interventions, and meetings of the hospital blood transfusion committee for education and sensitization of medical staff will go a long way in ensuring appropriate usage and good transfusion practice. [ABSTRACT FROM AUTHOR]

Background: Due to similar symptoms of abdominal pain, acute pancreatitis (AP) is often difficult to differentiate from acute aortic dissection (AAD) in clinical practice. It is unknown whether serum amylase and coagulation function indices can be used to distinguish AP from AAD. Methods: In this retrospective study, 114 AP patients (AP group) and 48 cases with AAD (AAD group) admitted for acute abdominal pain were enrolled for a final analysis. The levels of serum amylase and coagulation function indices, including prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (APTT), fibrinogen (FIB), and D-dimer (DD), were tested before or on admission and compared between the two groups. Student's t-test was adopted for comparing the mean. Model discrimination was evaluated by using the area under the receiver operating characteristic curve (AUC). Comparison of AUC was performed by using the Z-test. Results: Compared with the AAD group, amylase and FIB were both significantly increased, while DD was significantly lower in the AP group (all p < 0.01). There were no statistically significant differences of PT, INR, and APTT between AP and AAD (all p > 0.05). The AUCs in distinguishing AP from AAD were 0.913, 0.854, and 0.837 for amylase, FIB, and DD, respectively, but there were no significant differences observed among amylase, FIB, and DD (all p > 0.05). Finally, the cutoff values (specificity, sensitivity, and Youden index) in distinguishing between AP and AAD were 114 μ/L (80.70%, 95.83%, 0.765) for amylase, 2.62 g/L (76.32%, 85.42%, 0.617) for FIB, and 2.74 mg/L (95.61%, 62.50%, 0.581) for DD, respectively. Conclusions: Amylase, FIB, and DD can demonstrate accurate and reliable diagnostic values, suggesting that they are useful and potential biomarkers in distinguishing AP from AAD. [ABSTRACT FROM AUTHOR]

Warfarin dosing remains challenging due to substantial inter‐individual variability, which can lead to unsafe or ineffective therapy with standard dosing. Model‐informed precision dosing (MIPD) can help individualize warfarin dosing, requiring the selection of a suitable model. For models developed from clinical data, the dependence on the study design and population raises questions about generalizability. Quantitative system pharmacology (QSP) models promise better extrapolation abilities; however, their complexity and lack of validation on clinical data raise questions about applicability in MIPD. We have previously derived a mechanistic warfarin/international normalized ratio (INR) model from a blood coagulation QSP model. In this article, we evaluated the predictive performance of the warfarin/INR model in the context of MIPD using an external dataset with INR data from patients starting warfarin treatment. We assessed the accuracy and precision of model predictions, benchmarked against an empirically based reference model. Additionally, we evaluated covariate contributions and assessed the predictive performance separately in the more challenging outpatient data. The warfarin/INR model performed comparably to the reference model across various measures despite not being calibrated with warfarin initiation data. Including CYP2C9 and/or VKORC1 genotypes as covariates improved the prediction quality of the warfarin/INR model, even after assimilating 4 days of INR data. The outpatient INR exhibited higher unexplained variability, and predictions slightly exceeded observed values, suggesting that model adjustments might be necessary when transitioning from an inpatient to an outpatient setting. Overall, this research underscores the potential of QSP‐derived models for MIPD, offering a complementary approach to empirical model development. [ABSTRACT FROM AUTHOR]

Abstract This study aimed to ascertain how the current two ART regimens used in Ghana affected HIV patients’ coagulation profiles. A case-control study was conducted on 102 HIV positive patients at the Mampong Municipal Hospital. Coagulation parameters measured showed APTT was normal in majority of ART-experienced participants but prolonged in majority of ART-naïve participants. The mean platelet count was significantly higher in ART-experienced participants. No significant differences were found between the coagulation profiles of ART-experienced patients on two different drug regimens. In conclusion, current ART can enhance the coagulation profiles in HIV-infected patients, by improving platelet count and APTT.

Purpose: To determine the safety and efficacy of phytonadione in patients with an elevated international normalized ratio (INR) secondary to chronic liver disease without active bleeding. Methods: This retrospective chart review compared hospitalized patients from 2015 to 2022 with a diagnosis of chronic liver disease, a baseline INR of 1.2 to 1.9, and without active bleeding who did or did not receive phytonadione. The primary outcome was the incidence of new bleeding. The incidence of thrombosis and change in INR were also evaluated. Results: A total of 133 patients were included, of which 46 received phytonadione (mean 2.46 doses and mean dose 7.95 mg, 72.74% intravenously). Child-Pugh scores were higher in phytonadione patients (8.7 vs 9.93, P =.0003). There was no difference in the incidences of new bleeding (9.20 vs 13.04%, P =.492) or thrombosis (3.45 vs 0%, P =.203) between the control and phytonadione groups. After phytonadione administration, there was no change in INR, while INR increased by 0.24 in the control group (P =.025). Conclusion: In chronic liver disease patients who were not bleeding, phytonadione did not reduce INR or the incidence of new bleeding. [ABSTRACT FROM AUTHOR]

Background : Several studies have examined INR fluctuations using pharmacokinetic (PK) models or post-hoc INR values after completing nirmatrelvir/ritonavir, but further study of the effects of the drug interaction with warfarin during treatment is necessary. Case Summary : Nirmatrelvir/ritonavir is largely utilized in the outpatient setting so data regarding INR trends in hospitalized patients on warfarin is limited. However, many who receive nirmatrelvir/ritonavir outpatient experience difficulty with presenting to clinic for INR checks due to feeling acutely ill along with isolation precautions. We present the case of a patient receiving warfarin and utilizing home INR testing for monitoring. After diagnosis of coronavirus disease of 2019 (COVID-19), she was started on nirmatrelvir/ritonavir on day five after testing positive. Most recent INR prior to the start of therapy was 2.7 and had been stable on the same dose for months prior to infection. On day two of nirmatrelvir/ritonavir, her INR rose to 4.0 on home point of care INR testing. Despite reducing her dose of warfarin by 15%, her INR remained supratherapeutic the day after completing nirmatrelvir/ritonavir (4.0) and for several checks after. One month after completion of therapy, her INR returned to therapeutic levels. Practice Implications : While PK models and case series have hypothesized both potential increases or decreases in INR with the nirmatrelvir/ritonavir and warfarin interaction, COVID-19 infection itself can cause several pharmacodynamic changes which can increase INR, including decreased appetite and, in severe cases, organ dysfunction. This case provides real-world insight into the drug interaction between nirmatrelvir/ritonavir and the drug-disease state interaction between warfarin and COVID-19. [ABSTRACT FROM AUTHOR]

Abstract Introduction We previously conducted a prospective, observational post-marketing surveillance study to assess the safety and effectiveness of four-factor prothrombin complex concentrate (4F-PCC) for rapid vitamin K antagonist (VKA) reversal in Japanese patients. Methods This subgroup analysis compared the safety, especially thromboembolic events (TEEs), and effectiveness of 4F-PCC by stratifying patients into two subgroups according to baseline international normalized ratio (INR) levels with

Purpose: To evaluate for correlation between MRI paraspinous muscle (PSM) enhancement and clinical measures of cirrhosis severity (CMCS) utilizing established imaging biomarkers of sarcopenia as comparison. Materials and methods: Retrospective evaluation of 224 patients (mean age 59.6± 9.7 years, 135 males and 89 females) with liver cirrhosis who underwent contrast-enhanced MRI between August 2021 and August 2022 was performed. Assessed variables included: body mass index (BMI), varices and ascites present on imaging (VPI and API), albumin, total bilirubin (Tbili), international normalized ratio (INR), creatinine, MELD score, as well as history of paracentesis (PH), spontaneous bacterial peritonitis, and variceal bleed (VBH). These variables were compared to PSM skeletal muscle index (SMI), PSM signal fat fractions (sFF), and PSM contrast enhancement fraction (CEFR) calculated on arterial (CEFR-ART), portal venous (CEFR-PV), and delayed (CEFR-DEL) phases collected on MRI. Results: Patients with MELD>17, PH, and VPI had lower PSM CEFR-ART (0.06vs. 0.11, p = 0.01; 0.07vs. 0.11, p = 0.01; and 0.09vs. 0.13, p = 0.03, respectively). PSM CEFR-ART correlated negatively with MELD. Patients with MELD>17 and PH had lower PSM CEFR-PV (0.16vs. 0.23, p = 0.02; 0.18 vs. 0.23, p = 0.01, respectively). PSM CEFR-PV correlated positively with albumin and negatively with Tbili, INR, and MELD. PSM CEFR-DEL correlated negatively with Tbili and MELD. Patients with API, PH, and VBH had lower PSM SMI (4.68vs. 5.59, p<0.001; 4.37vs. 5.48, p<0.001; 4.78vs. 5.35, p = 0.04, respectively). PSM SMI correlated negatively with Tbili and positively with BMI. PSM sFF correlated positively with BMI, PSM CEFR-PV, and PSM CEFR-DEL. Conclusion: PSM CEFR is significantly reduced on MRI in patients with clinical manifestations of severe liver cirrhosis. Further investigation into PSM CEFR's usefulness as an imaging biomarker for evaluating liver disease severity is warranted. [ABSTRACT FROM AUTHOR]

Aim Methods Results Conclusion Recent evidence suggests that acute liver failure (ALF) in some patients may reflect a dysregulated immune response, and that corticosteroids improve survival of the native liver in ALF patients with high serum alanine aminotransferase levels, which are an indication of liver inflammation. However, it is unclear whether steroids are effective for pediatric acute liver failure (PALF). The aim of this retrospective case–control study is to examine whether steroid therapy for PALF accompanied by immune activation improves the survival of native liver and to identify factors that predict responses to steroid treatment.Of 38 patients with PALF treated at Kyoto University Hospital from February 2006 to August 2022, 19 receiving steroids who met the specific criteria for identifying the pathophysiology of immune activity in the liver (the “Steroid group”), and seven steroid‐free patients who also met the criteria (“Nonsteroid group”) were enrolled. Patients in the “Steroid group” were categorized as “responders” or “nonresponders” according to treatment outcome. Clinical and histological data were analyzed.Survival of the native liver in the Steroid group was significantly higher than that in the Nonsteroid group (68% vs. 0%, respectively; p = 0.0052). Nonresponders were significantly younger, with higher Model for End‐stage Liver Disease and pediatric end‐stage liver disease scores, higher prothrombin time – international normalized ratio, and higher serum ferritin levels than responders. Massive hepatic necrosis was more common in nonresponders.Steroid therapy is effective for PALF patients with liver inflammation; however, liver transplantation should be prioritized for young children with ALF accompanied by severe coagulopathy or massive hepatic necrosis. [ABSTRACT FROM AUTHOR]

Background: To determine the paranasal changes and inflammatory markers that may cause primary acquired nasolacrimal duct obstruction (PANDO) and to determine their relationship with success rates on different types of surgeries. Main body: We retrospectively reviewed the blood sample and computed tomography (CT) results on 92 patients who underwent dacryocystorhinostomy (DCR) surgery for PANDO and 82 healthy controls. Age, gender, paranasal abnormalities, hemogram values, International Normalized Ratio (INR) values, type of surgery, and recurrence rate were recorded; systemic Immune-inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), monocytes-to- lymphocyte ratio (MLR) and platelet-to-lymphocyte ratio (PLR) were calculated in both groups. In the case group, total white blood cells, monocytes, and INR values were significantly lower (p < 0.05). Platelet, lymphocyte, neutrophil, PLR, MLR, NLR, and SII values did not differ significantly between the control and case groups (p > 0.05). There was no significant difference in the CT results between the groups (p > 0.05). No correlation was found between CT findings and inflammatory markers. Dacryocystitis (DC) was seen in 20% of patients and they were all in the case group. No correlation was found between recurrence rate and age, gender, type of surgery, CT findings, and blood results (p > 0.05). The recurrence rate was significantly higher in patients with bilateral PANDO and with DC (p < 0.05). Short conclusion: The incidence of PANDO may not be directly related to paranasal abnormalities and systemic inflammation. Low INR values may cause obstruction in the nasolacrimal duct. Age, gender, type of surgery, CT findings, and inflammation level do not affect the success of the surgery. [ABSTRACT FROM AUTHOR]

Background: Thyroid hormones significantly influence cardiovascular pathophysiology, yet their prognostic role in acute aortic dissection (AAD) remains inadequately explored. This study assesses the prognostic value of thyroid hormone levels in AAD, focusing on the mediating roles of renal function and coagulation. Methods: We included 964 AAD patients in this retrospective cohort study. Utilizing logistic regression, restricted cubic splines, and causal mediation analysis, we investigated the association between thyroid hormones and inhospital mortality and major adverse cardiovascular events (MACEs). Results: In AAD patients overall, an increase of one standard deviation in FT4 levels was associated with a 31.9% increased risk of MACEs (OR 1.319; 95% CI 1.098-1.584) and a 36.1% increase in in-hospital mortality (OR 1.361; 95% CI 1.095-1.690). Conversely, a higher FT3/FT4 ratio was correlated with a 20.2% reduction in risk of MACEs (OR 0.798; 95% CI 0.637-0.999). This correlation was statistically significant predominantly in Type A AAD, while it did not hold statistical significance in Type B AAD. Key renal and coagulation biomarkers, including blood urea nitrogen, creatinine, cystatin C, prothrombin time ratio, prothrombin time, and prothrombin time international normalized ratio, were identified as significant mediators in the interplay between thyroid hormones and MACEs. The FT3/FT4 ratio exerted its prognostic influence primarily through the mediation of renal functions and coagulation, while FT4 levels predominantly impacted outcomes via a partial mediation effect on coagulation. Conclusion: FT4 levels and the FT3/FT4 ratio are crucial prognostic biomarkers in AAD patients. Renal function and coagulation mediate the association between the thyroid hormones and MACEs. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To evaluate the differences of clinical efficacy and safety between generic and original apixaban after centralized drug volume-based procurement, so as to provide real-world clinical research evidence for the re-evaluation of domestic generic drugs after marketing, and provide supporting evidence for clinicians and related professionals in drug selection. METHODS: This study was a multicenter, large-sample, real-world retrospective cohort study based on the concept of comparative effect research. Clinical data of adult patients underwent hip or knee replacement or post-operation treated with apixaban were extracted from the information system database of the First Affiliated Hospital of Wannan Medical College, Guangdong Provincial People’ s Hospital, Henan Provincial People’ s Hospital and the First Affiliated Hospital of Xi’ an Jiaotong University from Jan. 1st 2019 to Apr. 1st 2022. Patients were divided into 295 cases in original drug group, 641 cases in generic drug group 1 and 50 cases in generic drug group 2 according to the specific medication. Differences in efficacy related to prothrombin time, international normalized ratio, activated partial thromboplastin time and incidence of venous thromboembolic events (VTE), and differences in safety related to aspartate transaminase (AST), alanine aminotransferase (ALT), urea, blood uric acid and creatinine were compared between two groups. RESULTS: (1) In terms of efficacy, after treatment, differences in prothrombin time, international normalized ratio, activated partial thromboplastin time and VTE incidence among three groups were not statistically significant (P>0. 05). (2) In terms of safety, after treatment, differences in the levels of AST, ALT, urea, blood uric acid and creatinine as well as the incidence of related adverse events among three groups were not statistically significant (P>0. 05). CONCLUSIONS: Generic apixaban is comparable to the original drug in terms of efficacy and safety after centralized drug volume-based procurement. [ABSTRACT FROM AUTHOR]

Purpose Yttrium 90 (Y90) transarterial radioembolization (TARE) is effective for unresectable hepatocellular carcinoma (HCC) or to bridge/downstage before transplant; however, optimal patient selection is not well-described. This study aims to identify factors that increase risk of liver decompensation resulting in hospital admissions after TARE. Methods Patients who received Y90 as their first treatment during 2012 to 2022 were identified from a prospectively collected database of 1675 HCC patients. Clinically significant hepatic decompensation was defined as total bilirubin more than or equal to 3 mg/dL or any increase in Model for End-stage Liver Disease (MELD) score resulting in readmission within 60 days or death. Results Of 137 patients, 7 (5.1%) developed hepatic decompensation requiring admission within 30 days and an additional 8 (10.9%) within 60 days. Two of these patients (1.4%) died and two (1.4%) required urgent transplant within 2 months. Preprocedure albumin less than 3.5 gm/dL (p = 0.0207), international normalized ratio more than 1.2 (p = 0.017), ascites (p = 0.036), elevated MELD (p = 0.012), and Child-Pugh (p = 0.007) scores were significant predictors of decompensation, while creatinine and sodium were not. Patients with Child-Pugh B score were three to four times more likely to decompensate (28 vs. 8%) compared to Child-Pugh A. For every unit increase in Child-Pugh score more than 6, odds of decompensation increased by a factor of 2.15. Conclusion Y90 TARE is safe and effective; however, 10.9% patients require readmission for worsened liver function. Because ascites is a significant factor in predicting decompensation and all patients require adequate renal function to receive Y90 TARE, Child-Pugh score may be more useful than MELD for patient selection. Further risk stratification may be required for those with a Child-Pugh score more than or equal to 7. [ABSTRACT FROM AUTHOR]

Introduction: Merkel cell carcinoma (MCC) is an aggressive skin cancer with a poor prognosis, which only improved with the introduction of immunotherapies. An MCC prediction model with high diagnostic accuracy is lacking. The aim was to develop an MCC prognostic score (MCC-PS) based on combinations of previously proposed risk factors. Methods: A multicentric, retrospective study was conducted to develop MCCPS, which included age, neuron-specific enolase (NSE), C-reactive protein (CRP), creatinine, bilirubin, and international normalized ratio (INR). Creatinine, bilirubin, and INR were used to calculate the model of end-stage liver disease (MELD) score. A total of 98 patients were included in the study, including 36.7% with stage I according to American Joint Committee on Cancer 2018 (n = 36), 30.6% with stage II (n = 30), 25.5% with stage III (n = 25), and 7.1% with stage IV (n = 7). Survival data of MCC patients were correlated with selected laboratory parameters and risk factors. Primary endpoint was MCC-specific survival (MSS) and the secondary endpoint was progression-free survival. Several statistical methods were used to develop the prognostic score, including correlation analysis, Kaplan-Meier curves, Cox regression, and time-dependent receiver operating characteristic analysis. Results: The MCC-PS is based on the sum of the following baseline variables: elevated CRP (≥5.5 mg/l), elevated NSE (≥22.8 μg/l), MELD score ≥ 11, and age ≥ 75 years. An MELD score ≥ 11 was scored as 4 points, elevated NSE level as 3 points, elevated CRP level as 2 points, and age ≥ 75 years as 1 point. A high-risk group according to the MCC-PS was characterized by a score of 4 or more points. The high-risk group was associated with a worse prognosis than the lowrisk group (1-year MSS 62%, 2-year 43.1%, 5-year 17.6% as compared to 1-year MSS 79.5%, 3-year 75%, 5-year 72%). Notably, the developed MCC-PS predicts MCC outcome measures with high accuracy (3-year MSS: area under the curve (AUC) 0.934, sensitivity 87.5% and specificity 82.2%; 5-year MSS: AUC 0.93, sensitivity 89% and specificity 82%). Conclusion: MCC-PS is the first prognostic score predicting MCC outcome with a high accuracy based on five easily available laboratory parameters and patient's age. An MCC-PS of 4 or more indicates a high-risk patient associated with a poor prognosis. Conclusion: MCC-PS is the first prognostic score predicting MCC outcome with a high accuracy based on five easily available laboratory parameters and patient's age. An MCC-PS of 4 or more indicates a high-risk patient associated with a poor prognosis. [ABSTRACT FROM AUTHOR]

Background The present study unveiled the effectiveness of ready-to-use brodifacoum blocks (0.005%) against the prevalent field rat species in southeast Asia, Bandicota bengalensis. Brodifacoum, a more potent second-generation anticoagulant, offers a solution for managing rodents resistant to other anticoagulants of its class. Methodology Male and female bandicoot rats caught wild were exposed to brodifacoum for 1, 2, and 3 days in both the no-choice and bi-choice tests. The observations included mortality rates, impact on body weight, food consumption, blood clotting factors, organ weights, and histological changes. Results Results indicated 100% mortality within 2–3 days in the no-choice tests, and 50.00%–83.33% mortality in the bi-choice tests within 5 to 8 days. The median lethal feeding periods were determined to be 2.10 and 2.33 days for male and female rats, respectively. Toxicity symptoms included bleeding from the nose, gums, and feet. While no significant effects were observed on body weight or organ weights, food consumption decreased notably in no-choice tests. Additionally, significant increases in prothrombin time and activated partial thromboplastin time were noted 24 h post-treatment in the no-choice tests, with post-treatment international normalized ratios of 9.45–14.20 and 1.52–3.03 in the no-choice and the bi-choice tests, respectively. Histological analysis revealed mild to severe necrotic changes in the liver and kidneys after brodifacoum treatment. Conclusions Overall, this study underscores the potential of ready-to-use brodifacoum blocks as an effective tool for rodent population control, offering a viable alternative to other second-generation anticoagulant rodenticides. [ABSTRACT FROM AUTHOR]

Background and Objectives: Patients with type 2 diabetes (T2D) have a high prevalence of non-alcoholic fatty liver disease (NAFLD) (55%) and are at increased risk for developing non-alcoholic steatohepatitis, a severe form of NAFLD. Early detection of advanced fibrosis in patients with T2D and NAFLD is crucial and can prevent progression to chronic liver disease, cirrhosis, and hepatocellular carcinoma. However, screening for liver disease and risk-stratification pathways are not established in patients with T2D. We evaluated the efficacy of using the automated fibrosis-4 (FIB-4) index in routine clinical settings to identify patients requiring further specialist evaluation. Materials and Methods: In this prospective cohort study, individuals diagnosed with T2D were recruited from diabetes clinics at a tertiary university hospital. Demographic, clinical, and laboratory data were comprehensively collected. The FIB-4 index was automatically calculated and integrated into the hospital's electronic medical records (EMRs), which were then stratified by age. Patients with advanced fibrosis (FIB-4 index ≥ 1.3) were referred to a specialist. Student's t-test or the Mann–Whitney U test was used to analyze variables associated with advanced fibrosis. Logistic regression was used to identify predictors of advanced fibrosis. Results: Among the 318 patients with T2D, 9.7% had advanced fibrosis. The majority were females (54.7%) and Saudi nationals (89.6%). Several factors, including age, platelet count, total bilirubin, serum albumin, total cholesterol, low-density lipoprotein, transaminases, and gamma-glutamyl transferase (GGT), showed significant associations with advanced fibrosis (all p < 0.05). Older age, elevated total bilirubin and GGT levels, and prolonged international normalized ratio emerged as independent predictors of advanced fibrosis. Conclusions: Integrating the FIB-4 index into the EMR during the routine care of patients with T2D proved to be a valuable tool in effectively identifying individuals at risk of advanced fibrosis. Our findings emphasize the need for further research to refine screening strategies in this high-risk population. [ABSTRACT FROM AUTHOR]

Background: Spinal muscular atrophy (SMA) is a progressive neurodegenerative disorder that can be treated with intrathecal nusinersen, an antisense oligonucleotide. In addition to efficacy, safety is a determining factor in the success of any therapy. Here, we aim to assess the safety of nusinersen therapy in paediatric patients with SMA. Methods: Laboratory data of paediatric patients with SMA who received nusinersen between October 2019 and May 2022 were retrospectively analysed. Results: During the observation period, 46 infants and children aged 2.9 months to 13.6 years received a total of 213 nusinersen doses without safety concerns. Inflammatory markers were stable throughout the study. International normalized ratio was increased by 0.09 per injection. Urea levels were increased by 0.108 mmol/L, and cystatin C decreased by 0.029 mg/L per injection. There were no significant changes in platelet count, activated partial thrombin time, creatinine levels or liver enzyme levels during treatment. The cerebrospinal fluid (CSF) leukocyte count remained stable, and total protein increased by 24.038 mg/L per injection. Conclusion: Our data showed that nusinersen therapy is generally safe in children with SMA. Laboratory monitoring did not identify any persistent or significantly abnormal findings. CSF protein should be monitored to gain more insights. [ABSTRACT FROM AUTHOR]

Introduction Methods Results Conclusion Specific assays of plasma rivaroxaban level are not always readily available with short turnaround time, which hamper the management of urgent clinical situations. In this study, we aimed to build a predictive formula of plasma rivaroxaban levels from international normalized ratio (INR) value and validated in real world clinical situations.Ninety‐four patients who were taking rivaroxaban participated in the study. Patients were randomized into testing cohort and validation cohorts. The prediction formula was built from the testing cohort and then validated in validation cohort. The predictive performance was further validated on real‐world clinical requests.The root mean square error (RMSE) of the predictive formula for the testing and validation cohorts were 61.81 and 69.32 ng/mL, respectively. The sensitivity and specificity for the formula to predict the threshold plasma rivaroxaban level of 75 ng/mL were 95% (95% CI: 85.4%–100%) and 87.5% (95% CI: 71.3%–100%), respectively, in real‐world clinical situations.Plasma rivaroxaban level of threshold level of 75 ng/mL can be calculated from prediction formula by INR value with satisfactory accuracy and it can be used to guide the decision for reversal. [ABSTRACT FROM AUTHOR]

Warfarin-related nephropathy (WRN) is defined as acute kidney injury subsequent to excessive anticoagulation with warfarin. Patients with mechanical prosthetic valves require long-term anticoagulant therapy. Nonetheless, warfarin remains the sole available option for anticoagulant therapy. Consequently, patients with mechanical prosthetic valves constitute a special group among the entire anticoagulant population. The present study recorded two cases of patients who had undergone mechanical prosthetic valve surgery and were receiving warfarin therapy. They presented to the hospital with gross hematuria and progressive creatinine levels. Notably, their international normalized ratio (INR) did not exceed three. Subsequent renal biopsies confirmed WRN with IgA nephropathy. The two patients continued to receive warfarin as anticoagulation therapy and were prescribed oral corticosteroids and cyclophosphamide, which resulted in improved renal function during the follow-up. Based on a review of all relevant literature and the present study, we proposed a new challenge: must elevated INR levels be one of the criteria for clinical diagnosis of WRN? Perhaps some inspiration can be drawn from the present article. [ABSTRACT FROM AUTHOR]

In 2016, a nationwide elimination program for hepatitis C virus (HCV) was initiated in Iceland, entitled Treatment as Prevention for Hepatitis C (TraP HepC), providing unrestricted access to antiviral treatment. The aims were to describe the changes in etiology and epidemiology of cirrhosis in Iceland and to assess the trends in HCV-related cirrhosis following TraP HepC. The study included all patients newly diagnosed with cirrhosis in 2016–2022. Diagnosis was based on liver elastography, histology, or 2 of 4 criteria: cirrhosis on imaging, ascites, varices, or elevated international normalized ratio (INR). Over the study period, 342 new cirrhosis patients were identified, 223 (65%) males, median age 62 years. The crude overall incidence was 13.8 cases per 100,000 inhabitants annually. The most common etiologies were alcohol-related liver disease (ALD) (40%), metabolic dysfunction-associated steatotic liver disease (MASLD) (28%), and HCV with or without alcohol overconsumption (15%). The number of HCV cirrhosis cases was unusually high in 2016 (n = 23) due to intensified case-finding, but decreased significantly over the study period (p < 0.001) to n = 1 (2021) and n = 2 (2022). The overall 5-year survival was 55% (95% CI 48.9–62.3%). The most common causes of death were hepatocellular carcinoma (26%) and liver failure (25%). During the past two decades, the incidence of cirrhosis has increased extraordinarily in Iceland, associated with increased alcohol consumption, obesity, and HCV. ALD and MASLD now collectively make up two thirds of cases in Iceland. Following a nationwide elimination program, incidence of HCV cirrhosis has dropped rapidly in Iceland. [ABSTRACT FROM AUTHOR]