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Background: Hepatocellular carcinoma (HCC) is the first cause of cancer in Egypt. Recently, HCC developed post direct-acting antivirals (DAAs) differ in some characteristics from those developed without DAAs exposure regarding the biological features and behavior of HCC. We aimed to assess the epidemiological, clinical, laboratory, and radiological findings besides the biological behavior of HCC patients post DAAs in comparison to HCC not exposed to DAAs. An analytic cross-sectional research was performed at the National Liver Institute which is a tertiary multidisciplinary HCC center. Subjects included hepatitis C virus patients and were allocated into two groups: group I included 2036 HCC cases post-DAA treatment and group II included 6338 HCC cases who did not receive DAAs. Subjects were examined to evaluate clinical, laboratory, and radiological findings. Tumor staging was done using the BCLC staging system. Results: Group II showed a more advanced Child–Pugh score, FIB-4 index, and MELD score than Group I (P = 0.001). The multiplicity of hepatic focal lesions was elevated in group I than in group II (P = 0.033). AFP level was significantly elevated in group I than in group II (p = 0.012). Portal vein invasion was significantly elevated in group I than in group II patients (P = 0.001). Extrahepatic spread of HCC was significantly elevated in group I than in group II (P = 0.001). Infiltrative lesions were significantly elevated in group I than in group II (P = 0.002). Conclusion: Our study detected that the behavior in HCC post DAAs treatment is more aggressive in respect of the number of lesions, PV invasion; local and distant metastasis, and serum AFP level than in patients unexposed to DAAs. Strict surveillance in cirrhotic patients treated with DAA should be followed according to the international guidelines for early diagnosis and treatment of HCC. [ABSTRACT FROM AUTHOR]

A 43‑year‑old male diagnosed with end‑stage renal disease on hemodialysis with extensive thrombosis in the inferior vena cava and bilateral iliofemoral vein underwent renal transplantation at our institute. Thrombosis in the major vein can have serious consequences for the success of the transplantation. The common anastomosing vein during renal transplantation is the right external iliac vein, but due to extensive thrombosis, left native nephrectomy with the orthotopic placement of the donor kidney was done. During surgery, the donor renal vein was anastomosed with the left renal vein, and the donor renal artery was anastomosed with the aorta. Postsurgery, the creatinine level showed a progressive decline over time and the patient was discharged home. [ABSTRACT FROM AUTHOR]

Four-factor prothrombin complex concentrate (4F-PCC) is standard of care for emergent vitamin K antagonist (VKA) reversal but optimal dosing is uncertain. This meta-analysis estimated the proportion of patients treated with fixed dose (FD) 4F-PCC who achieved adequate reversal and compared safety and efficacy of FD versus weight-based dose (WB) strategies. This review was conducted according to PRISMA guidelines. Medline and Scopus were searched and included studies evaluating FD regimens and comparing FD and WB for emergent VKA reversal. Data was pooled using random effects. Subgroup analyses examined heterogeneity. Risk of bias was assessed with Newcastle-Ottawa Scale and RoB2 score. Twenty-three studies (n = 2055) were included with twelve (n = 1143) comparing FD versus WB. The proportion of patients achieving goal INR with FD varied depending on the INR target, being significantly higher for INR <2 (90.9%, 95% Confidence Interval (CI) 87.2, 94.06) compared to INR <1.6 (70.97%, 95%CI 65.33, 76.31). Compared to WB, FD was less likely to achieve a goal INR <1.6 (Risk Difference (RD) −13%, 95% CI −21, −4) but achieved similar reversal for a goal INR <2.0, (RD −1%, 95%CI −7, 4). There was no difference in hospital mortality (RD 4%, 95%CI −2, 9) or thrombosis (RD 0.0%, 95%CI −3, 3). FD VKA reversal was associated with significantly lower attainment of goal INR compared to WB with lower INR targets. This did not translate to differences in hospital mortality, but these results should be interpreted cautiously in light of the observational nature of the included studies. • Optimal dosing of four-factor prothrombin complex concentrate (4F-PCC) for vitamin K antagonist reversal is uncertain. • Emerging interest in fixed dose 4F-PCC is due to potential decreased risk of thrombosis and cost. • When compared to variable dose 4F-PCC, fixed dose may decrease the attainment of goal INR. • This decrease did not translate to differences in patient centered outcomes between dosing schema. [ABSTRACT FROM AUTHOR]

Plasma is overused as a blood product worldwide; however, data supporting appropriate use of plasma is scant. Its most common utilization is for treatment of coagulopathy in actively bleeding patients; it is also used for coagulation optimization prior to procedures with specific coagulation profile targets. A baseline literature review in PUBMED and Google Scholar was done (1 January 2000 to 1 June 2023), utilizing the following search terms: plasma, fresh frozen plasma, lyophilized plasma, indications, massive transfusion protocol, liver disease, warfarin reversal, cardiothoracic surgery, INR < 2. An initial review of the titles and abstracts excluded all articles that were not focused on transfusional medicine. Additional references were obtained from citations within the retrieved articles. This narrative review discusses the main indications for appropriate plasma use, mainly coagulation factor replacement, major hemorrhage protocol, coagulopathy in liver disease, bleeding in the setting of vitamin K antagonists, among others. The correlation between concentration of coagulation factors and INR, as well as the proper plasma dosing with its volume being weight-based, is also discussed. A high value approach to plasma utilization is supported with a review of the clinical situations where plasma is overutilized or unnecessary. Finally, a discussion of novel plasma products is presented for enhanced awareness. [ABSTRACT FROM AUTHOR]

Background: Coronavirus disease (COVID-19) continues to be a major global public health issue. COVID-19 is highly contagious, and numerous mitigation strategies have recently been implemented to prevent the spread of this disease. Pharmacists utilize telecommunication technology to provide patient care services, thus increasing patient access to pharmaceutical services. There was a scarcity of evidence regarding the impact of telepharmacy on patient outcomes during COVID-19. Therefore, the aim of this study was to summarize the available research evidence on the impact of telepharmacy on patient outcomes during COVID-19. Methods: A systematic literature search was conducted between January 2020 to September 2022 in Ovid MEDLINE, Ovid Embase, and Cochrane Central Register of Controlled Trials, using appropriate terms on telepharmacy, COVID-19, and patient outcomes. Only studies that investigated the impact of telepharmacy on patient outcomes during COVID-19 were included. A systematic literature search was conducted between January 2020 to September 2022 in Ovid MEDLINE, Ovid Embase, and Cochrane Central Register of Controlled Trials, using appropriate terms on telepharmacy, COVID-19, and patient outcomes. Only studies that investigated the impact of telepharmacy on patient outcomes during COVID-19 were included. Results: A total of three studies were included in the review. The telepharmacy services were offered via virtual anticoagulation clinic, retail community telepharmacy through information technology tools, and RxLive® telepharmacy program. All studies included in the review demonstrated that the provision of telepharmacy services during COVID-19 had an overall positive impact on the patient outcomes such as a reduction in the rates of hospitalisation and medication-related problems and maintaining the international normalized ratio values within the therapeutic range. Conclusion: This review provides evidence that telepharmacy services have been successful in improving patient outcomes during the COVID-19 pandemic, including reductions in medicines-related problems and hospitalisation rates. As the pandemic continues, there is an urgent need to further expand telepharmacy services, using modern communication technologies such as televideo, especially for patients living in remote areas. There is a need to conduct further pre-post-intervention studies to address this gap. [ABSTRACT FROM AUTHOR]

Copyright of Cukurova Medical Journal / Çukurova Üniversitesi Tip Fakültesi Dergisi is the property of Cukurova University, Faculty of Medicine and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Objective: To investigate the clinical symptoms of coronavirus disease 2019 (COVID-19) patients with and without B.1.1.7 mutation. Methods: This retrospective observational study included COVID-19 patients who were divided into two groups, the mutation and the non-mutation group. Demographics characteristics, clinical characteristics, laboratory parameters, and mortality rates were recorded and compared between the two groups. Results: A total of 196 patients were included in the study. The relationship between the mutant virus status and sex, age, comorbidity, survival status, and disease severity was not significant (P>0.05). No significant differences were found in duration of hospitalization between the mutation and the non-mutation group (P>0.05). However, there was a statistically significant difference between patients with and without mutant viruses in hemoglobin, mean platelet volume, procalcitonin, low density lipoprotein, ironbinding capacity, potassium, calcium, C-reactive protein, folate, creatine kinase myocardial band, D-dimer, and international normalized ratio (P<0.05). Conclusions: No significant difference is found in mortality rate, disease severity or duration of hospitalization between the patients with and without variant B.1.1.7. Careful monitoring of COVID-19 patients is required for all variants. [ABSTRACT FROM AUTHOR]

Background: Warfarin is well known as a narrow therapeutic index that has prodigious variability in response which challenges dosing adjustment for the maintenance of therapeutic international normalized ratio. However, an appreciated population not on new oral anticoagulants may still need to be stabilized with warfarin dosing. Objective: The current study's main objective was to validate and compare two models of warfarin clinical algorithm models namely the Gage and the International Warfarin Pharmacogenetics Consortium (IWPC) with warfarin 5 mg fixed standard dosing strategy in a sample of Sudanese subjects. Method: We have conducted a cross-sectional study recruited from the out-patient clinic at a tertiary specialized heart center. We included subjects with unchanged warfarin dose (stabilized), and with therapeutic international normalized ratio. The predicted doses of warfarin in the two models were calculated by three different methods (accuracy, clinical practicality, and the clinical safety of the clinical algorithms). Main outcome measure: The primary outcomes were the measurements of the clinical (accuracy, practicality, and safety) in each of the two clinical algorithms models compared to warfarin 5 mg fixed standard dose strategy. Results: We have enrolled 71 Sudanese subjects with mean age (51.7 ± 14 years), of which (49, 69.0%) were females. There was no significant difference between the warfarin 5 mg fixed standard dose strategy and the predicted doses of the two clinical algorithm models (MAE 1.44, 1.45, and 1.49 mg/day [P =0.4]) respectively. In the clinical practicality, all of the three models had a high percent of subjects (95.0%, 51.9%, and 66.7%) in the ideal dose range in middle dose group (3-7 mg/ day) for warfarin 5 mg fixed standard dosing strategy, Gage, and IWPC clinical algorithm models respectively. However, a small percent of subjects was exhibited in the warfarin low dose group ≤ 3 mg/day (0.0%, 15.0%, and 10.0%) and warfarin high dose group ≥ 7 mg/day (0.0%, 33.3%, and 33.3%) for warfarin 5 mg fixed standard dosing strategy, Gage, and IWPC clinical algorithms respectively. In terms of clinical safety, the percent of subjects with severely over-prediction were 28.2%, 22.5%, and 22.5% for warfarin 5 mg fixed standard dosing, Gage, and IWPC, respectively. While the percent of severely under-prediction was 12.7%, 7.0%, and 5.6% for the warfarin 5 mg fixed standard dosing, Gage, and IWPC, respectively. Conclusion: The Gage and IWPC clinical algorithm models were accurate, more clinically practical, and clinically safe than warfarin 5 mg standard dosing in the study population. The cardiologist can use either models (Gage and IWPC) to stratify subjects for accurate, practical, and clinically safe warfarin dosing.. [ABSTRACT FROM AUTHOR]

We report a multi-morbid patient with mechanical aortic valve and unstable and sub-therapeutic levels of international normalized ratio (INR), initially in phenprocoumon and later in warfarin therapy. All efforts, including self-testing using Point of Care Testing with telemedicine support to stabilize the patient's INR within the therapeutic range, were unsuccessful. Since INR fluctuations can occur due to poor or varied dietary vitamin K, 180 μg/day vitamin K was added to the patient's warfarin treatment in an attempt to stabilize INR fluctuations. Three weeks later INR was in therapeutic range and remained within range for two consecutive months suggesting beneficial effect of vitamin K. Our updated literature review demonstrates that vitamin K supplementation can improve the stability of INR without improvement of time therapeutic range. < Learning objective: Vitamin K antagonist (VKA) is the only approved anticoagulation therapy in patients with mechanical heart valves. The quality of anticoagulation therapy in some of these patients is challenged. There is insufficient evidence to advise routine vitamin K supplementation to all patients receiving VKA treatment. Supplementation, however, could be considered in patients with persistent INR instability, where no alternative anticoagulation therapy is available.> [ABSTRACT FROM AUTHOR]

Copyright of Konuralp Medical Journal / Konuralp Tip Dergisi is the property of Duzce University Medical School and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

• Massive transfusions do not have clear initiation guidelines, despite being vital in trauma resuscitations. • Pediatric trauma patients requiring greater transfusion volumes have higher markers of metabolic acidosis and coagulopathy. • INR is correlated with higher transfusion volumes. Pediatric trauma patients may benefit from a balanced transfusion strategy, however, determining when to activate massive transfusion protocols remains uncertain. The purpose of this study was to explore whether certain scoring systems can predict the need for large volume transfusion. We conducted a retrospective review of pediatric trauma patients who presented to our center and required a transfusion of packed red blood cells. Baseline laboratory and clinical data were used to calculate Trauma Associated Severe Hemorrhage (TASH) score and a previously reported composite of acidosis and coagulopathy. We identified 518 pediatric trauma patients who presented to our center between January 1, 2013 and December 31, 2018. These patients were less than 18 years of age (mean 9.6 years) and had an injury severity score ranging from 1 to 50 (mean 11.3). Forty-three patients (8.3%) received a transfusion within 24 hours of presentation, ranging from 4 to 139 mL/kg of packed red blood cells (mean 23.1 mL/kg). Transfusion volume was associated with acidosis and coagulopathy scores (r = 0.37, p = 0.033) and international normalized ratio (INR) (r = 0.34, p = 0.03) but not TASH (p = 0.72). Patients with INR≥1.3 received a higher mean volume of packed red cells compared to those with normal values (34 versus 18 mL/kg, p = 0.046). Pediatric trauma patients who undergo transfusion of packed red blood cells are likely to require large volume transfusion if their baseline INR is ≥1.3. These patients may benefit from a balanced transfusion strategy, such as utilization of massive transfusion protocols or whole blood. [ABSTRACT FROM AUTHOR]

Background: Education is considered a crucial element in anticoagulation management for patients with atrial fibrillation, valvular disease, ischemic heart disease, and venous thromboembolism. However, the effects of education on the patients prescribed warfarin are seldom investigated. Objectives: This integrative review was conducted to explore the effects of educational programs on patients prescribed warfarin for the aforementioned cardiovascular diseases and to identify the components of effective programs. Methods : A systematic search of clinical trials was performed in 8 databases from inception to August 2020. Two reviewers performed the eligibility assessment, methodological evaluation, and data extraction. A total of 9 studies were included and analyzed via narrative synthesis. Results : Nine studies involving a combined total of 1335 patients were included in the review. The findings suggest that educational programs have potential benefits related to international normalized ratio control and warfarin knowledge. However, their effects on major bleeding and thromboembolic events are unremarkable. Stronger evidence is recommended to confirm these findings, and the limited evidence examining the effects of education on warfarin adherence, minor bleeding, abnormal international normalized ratio, readmission rate, and warfarin-related mortality requires further exploration. Verbal education supported by written materials was the main educational delivery mode. A lecture length of approximately 45 minutes was likely appropriate. Notably, the integration of educational strategies, application of follow-up interventions and monitoring measures, adoption of psychological theories in program development, and inclusion of nurses or pharmacists in program conduction seemed to be effective program components. Conclusions : The effects of educational programs on patients prescribed warfarin mainly for atrial fibrillation, valvular disease, ischemic heart disease, and venous thromboembolism remain inconclusive. Further research using randomized controlled trials is warranted. [ABSTRACT FROM AUTHOR]

Patients with critical illness often display variable hypo- and hypercoagulable sequalae requiring intense monitoring and anticoagulation pharmacotherapy to prevent or treat inappropriate clot formation. It is imperative to understand the various stages of the clotting cascade and where each pharmacotherapy agent exerts its therapeutic effect. Common coagulation tests are utilized to monitor the areas of the clotting cascade and the effects that anticoagulant pharmacotherapy exhibits. Many novel coagulation tests are also in development. The purpose of this narrative review is to evaluate commonly utilized coagulation tests that monitor anticoagulation while in the intensive care unit. [ABSTRACT FROM AUTHOR]

Background: Candidemia is a life-threatening condition; however, the predictive markers for candidemia and mortality are inadequate in cirrhotic patients. This study was conducted to propose candidate predictors for the occurrence of candidemia and 30-day mortality in hospitalized cirrhotic patients with bloodstream infection (BSI) and review the related literature. Methods: Cirrhotic patients with BSI between January 2011 and March 2020 were screened from the databank of a medical center and eligible patients were enrolled. Patients were separated into candidemia and bacteremia groups according to the results of blood cultures. Baseline characteristics, clinical presentation, and biochemistry data were collected at this time, as were microbiological data, medical management, use of antimicrobial agents, and outcome of the patients. The parameters and 30-day mortality were compared between candidemia and bacteremia groups. A combination of the MeSH terms and text terms related to candidemia and cirrhosis was searched in the electronic databases. Results: Four hundred and sixty cirrhotic patients with BSI were enrolled. Thirty-five patients with candidemia (7.6%) were identified. Nosocomial infection, intensive care unit (ICU) admission, antibiotics exposure ≥14 days, white cell count >10 K/mm³, and model for end-stage liver disease (MELD) score >24 were associated with candidemia. The 30-day mortality was 65.7% in the candidemia group and 37.9% in the bacteremia group (p = 0.001). Nosocomial infection, ICU admission, hepatoma, hepatic encephalopathy, international normalized ratio ≥1.2, platelet ≤150 K/mm³, estimated glomerular filtration rate <60 mL/min/1.73m², and MELD score >24 were associated with 30-day mortality. Six studies were identified. The results were consistent with our findings regarding low incidence of candidemia, and relevant risk factors are listed. Conclusion: Candidemia had low incidence but high mortality in hospitalized cirrhotic patients with BSI. New predictors were proposed for the occurrence of candidemia and 30-day mortality in these patients. [ABSTRACT FROM AUTHOR]

Copyright of Konuralp Medical Journal / Konuralp Tip Dergisi is the property of Duzce University Medical School and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Acute liver failure (ALF) in the paediatric patient is a multisystem complex disorder, which occurs in the absence of chronic liver disease. Globally, viruses remain a common cause but drugs, metabolic and autoimmune conditions are important triggers. In up to half of cases no specific cause is identified. The definition entails a coagulopathy with a Prothrombin time (PT) ≥ 15seconds or International Normalized Ratio (INR) ≥ 1.5 not corrected by vitamin K in the presence of hepatic encephalopathy (HE) or a PT ≥ 20 or INR ≥2 or above regardless of HE. HE can be difficult to recognize in children and is defined differently than HE in adults. Timely recognition of ALF improves outcomes and allows time to undertake investigations, provide supportive therapy and arrange transfer to a specialist paediatric liver centre with transplant capacity. The purpose of this article is to review the aetiologies of ALF in children and outline an approach to investigation, management and treatment. [ABSTRACT FROM AUTHOR]

Objective: The study aimed to evaluate the improvement of patient knowledge of warfarin use, satisfaction with pharmacists, and the quality of international normalized ratio (INR) control after the implementation of an anticoagulant clinic (ACC) service. Methods: This was a prospective single-group pre- and post-comparison study. Patients who were at least 20 years of age and participated in a pharmacist-managed ACC service were enrolled from February 2012 to September 2015. Each participant completed a self-administered questionnaire before and after the ACC service to evaluate changes in warfarin knowledge. Another questionnaire was distributed after the ACC to evaluate participants' satisfaction with the pharmacist service in the ACC. The INR levels before and after the ACC intervention were obtained to calculate the proportion of time spent in the therapeutic INR range (time in therapeutic range, TTR). Paired t-tests were used to compare changes in participants' knowledge related to warfarin use. Multiple linear regressions were performed to explore the predictors associated with the participants' knowledge scores and TTR after the ACC intervention. Results: One hundred and forty-eight participants were enrolled in this study. A significant improvement (31.5%,p<0.001) in the knowledge of warfarin use was observed at the end of the ACC intervention. The interaction between warfarin and food was the most confusing factor for participants in warfarin use. More than 95% of the participants perceived a positive value of the pharmacist-managed ACC service. However, the consultation fee was the least satisfactory of the ACC service. The average TTR increased from 51.0±34.3% to 78.6±24.5% (p<0.001) after the ACC service was implemented. Participants' education levels and baseline knowledge scores were significant determinants associated with the knowledge improvement in the appropriate warfarin use (p<0.001). Conclusions: A pharmacist-managed ACC improved patient knowledge of warfarin use and INR control, and led to high satisfaction with the pharmacist service in the ACC in Taiwan. Pharmacists should focus on patients with lower education levels to facilitate their understanding of the appropriate warfarin use for better health outcomes. [ABSTRACT FROM AUTHOR]

Warfarin is the core component in the management of various thromboembolic disorders, which requires specialized expertise to optimize outcomes. There is limited data comparing a pharmacist vs. a haematologist-managed anticoagulation clinic in our setting, and in the Middle East. We aimed to evaluate the effectiveness and safety of a pharmacist vs. a haematologist-managed anticoagulation clinic in the Ambulatory Care Center at King Abdulaziz Medical City, Jeddah, Saudi Arabia. A retrospective cohort study was conducted from 2016 to 2018, which included adult patients who have been followed-up for at least six months and who received warfarin for an extended period. The primary outcome was the proportion of time the patients in the two arms were in the therapeutic range. The secondary outcomes were the differences in expanded time in the therapeutic range, as well as the frequency of bleeding and thromboembolic events between the two arms. We enrolled 104 and 124 patients in the pharmacist and haematologist arms respectively. The median time in the therapeutic range for the pharmacist arm was 71.4%, IQR (60.8–83.8) vs. 65%, IQR (43.5–79.1), in the haematologist arm (p = 0.0049). The median expanded time in the therapeutic range was 86.4%, IQR (77.5–95.3) vs. 81.21%, IQR (67.1–93.3) in the pharmacist vs. haematologist arm (p = 0.015) respectively. Major bleeding events occurred in 5.7 % vs. 3.2 %, and thromboembolic events in 5.7% vs. 4%, in the pharmacist vs. haematologist arm respectively. Our results demonstrated that the time in the therapeutic range was significantly higher in the pharmacist arm, with no significant difference in bleeding and thromboembolic events compared to the haematologist arm. [ABSTRACT FROM AUTHOR]

Objective: To identify the different practice patterns of botulinum toxin injection (BTX) and electromyography (EMG) in patients receiving anticoagulation and to evaluate the incidence, reporting, and management of bleeding complications and compartment syndrome from BTX and EMG. Literature Survey: Systematic review of relevant clinical studies in PubMed/Medline and Embase databases using key terms from inception to 31 May 2020. All publications in the English language were included without demographic limits. Methodology: A comprehensive search was performed to identify all studies addressing BTX and EMG in patients receiving anticoagulants. Two reviewers independently screened the titles, abstracts, and full texts and extracted data based on a set of predefined inclusion and exclusion criteria. All studies that met the inclusion criteria were assigned their respective levels of evidence using the Joanne Briggs Institute (JBI) Level of Evidence for Effectiveness. Synthesis: Eighteen studies were included in this review of which there were nine studies each on BTX and EMG. The results indicated heterogeneity in the practice patterns of BTX and EMG in patients taking anticoagulants. These included the decision for continuation of anticoagulant, international normalized ratio (INR) results acceptable to practitioners, the modality for procedure guidance, and surveillance of bleeding complications. In addition, there were variations in the description of targeted muscles and description of needle sizes. The overall incidence of bleeding complications and compartment syndrome rates were low. Conclusions: Despite the varied practice in anticoagulated patients undergoing BTX or EMG, practitioners should allow periprocedural continuation of anticoagulants, targeting an INR of 2 to 3 while using the smallest needle (25 gauge or smaller) of appropriate length. Some of the evidence on procedural guidance and complication surveillance were weak and more research in these areas is required. [ABSTRACT FROM AUTHOR]

Background: Previous studies suggested that direct-acting antivirals (DAAs) against hepatitis C increased the blood coagulability of patients on warfarin. This study aims to descriptively investigate the effects of DAAs on the blood coagulability and liver function of patients on warfarin in Japan. Methods: The Medical Information Database Network (MID-NET®) was used as data source. Fluctuations of blood coagulability and liver function were examined before and after DAA treatment in patients who were prescribed both DAAs and warfarin at least once during the study period from January 1, 2010, to December 31, 2017. Results: For the 16 eligible patients, the mean values of both PT-INR and WSI (warfarin sensitivity index) defined as the value obtained by dividing the PT-INR by the warfarin daily dose slightly decreased at the date of completion of the DAA treatment in comparison with those at the date of initiation and subsequently increased at 12 weeks after treatment completion. In contrast, the warfarin daily dose increased at the date of completion of the DAA treatment, followed by a decrease at 12 weeks after its completion. Several laboratory tests related to the liver function also revealed a similar decrease at the end of the DAA treatment. Conclusion: The analysis of MID-NET® data provides useful information on drug safety assessment of real-world patients. The results of this study imply that fluctuation of the liver function test results may relate to the fluctuation of blood coagulability in patients on both DAA and warfarin. This study contributes to a deeper understanding of the usefulness and limitations of real-world data in MID-NET® for regulatory purposes. [ABSTRACT FROM AUTHOR]

Background: Direct-acting antivirals (DAA) improve sustained virological response (SVR) rates with normalization of liver enzymes in patients with hepatitis C. However, liver inflammation may persist despite virus eradication. We aimed to investigate the rate and risk factors for persistent elevated aminotransferase levels in patients with advanced fibrosis after DAA-induced SVR. Methods: From January 2017 to April 2018, chronic hepatitis C patients with advanced fibrosis and SVR after DAA treatment at the Taipei Veterans General Hospital were prospectively enrolled. Persistent liver inflammation after SVR was defined as an increase in levels of alanine aminotransferase (ALT) (>40 U/L) at SVR12. Results: A total of 461 patients were included (57.9% females, mean age 64 years, 69.6% genotype 1b, 46.4% cirrhosis). At SVR12, there was a decline in ALT levels (90.5 ± 80.8 U/L to 25.3 ± 26.5 U/L) from baseline levels. Persistent liver inflammation at SVR12 was detected in 45 patients (9.8%). The presence of cirrhosis, markers of impaired liver functions, history of interferonbased therapy, steatosis, and elevated ALT levels at baseline was associated with persistent liver inflammation after SVR12. Results of multivariate analysis indicated that levels of baseline serum total bilirubin (odds ratio [OR]: 2.605, 95% CI: 1.158-5.858), international normalized ratio (OR: 14.389, 95% CI: 1.754-118.049), ALT (OR: 1.006, 95% CI: 1.003-1.009), and the presence of steatosis (OR: 3.635, 95% CI: 1.716-7.698) were independent predictors of persistent liver inflammation at SVR12. Conclusion: Persistent liver inflammation is not uncommon in chronic hepatitis C patients with advanced fibrosis after DAAinduced SVR. It is associated with impaired baseline liver function and steatosis. Long-term follow-up is required to assess the implication of liver inflammation on disease progression. [ABSTRACT FROM AUTHOR]

Copyright of Cukurova Medical Journal / Çukurova Üniversitesi Tip Fakültesi Dergisi is the property of Cukurova University, Faculty of Medicine and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Objective: We have reported a case of a drug-drug interaction (DDI) involving warfarin and Δ-9-tetrahydrocannabinol (THC) that resulted in a supratherapeutic international normalized ratio (INR) level. The purpose of this case report is to highlight the possibility of a pharmacokinetic DDI between THC and warfarin.Case Summary: A 67-year-old Caucasian man suffering from chronic pain presented to a dispensary in Buffalo, NY, for a refill of his medical cannabis (MC). The patient asked to speak with the pharmacist, and during their discussion the patient stated that he had a supratherapeutic INR level of 5.2 measured at home with a self-test device. The patient had no evidence of bleeding, and administration of warfarin was held for 2 days before the INR level returned to a normal range. The supratherapeutic level occurred when the patient was self-titrating his dose of THC and scored an 8, or "probable," on the Naranjo Adverse Drug Effect Probability Scale.Practice Implications: Warfarin and cannabinoids such as THC are both metabolized by cytochrome P450 (CYP) isozymes present in the liver and gastrointestinal tract. In the case described, a dose increase of 7.35 mg THC preceded an INR elevation of 5.2, but did not result in any bleeding. These observations are suggestive of a DDI involving warfarin and THC. Clinicians involved with MC should have adequate knowledge of the drugs that act as substrates, inhibitors, and inducers of CYP enzymes, including the major cannabinoids. [ABSTRACT FROM AUTHOR]

The purpose of this study was to determine whether tooth extraction for patients with ventricular assist devices (VADs) could be performed without interruption of anticoagulant and/or antiplatelet therapy and whether treatment with von Willebrand factor concentrates and desmopressin is required. The study consisted of three groups of patients undergoing oral surgery. The two experimental groups comprised patients with VADs, while the third group included cardiovascular patients without VADs who served as controls. All patients were treated intraoperatively with topical haemostatic agents (oxidized cellulose or collagen). The first group was additionally treated with fibrin glue. All 75 oral surgical procedures were performed under local anaesthesia without sedation. Three of 40 patients in the experimental groups and two of 20 patients in the control group suffered a haemorrhage, with no significant difference in the incidence of haemorrhage between the groups. The findings suggest that dental extraction can be performed without modification of oral anticoagulation or antiplatelet treatments, providing that INR is less than 3.5 on the day of the operation. It can further be hypothesized that an acquired coagulopathy in VAD patients does not influence the bleeding risk in dental extractions, and so the administration of desmopressin and/or von Willebrand factor concentrates is not required. [ABSTRACT FROM AUTHOR]

Copyright of Eastern Mediterranean Health Journal is the property of World Health Organization and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Introduction: Coagulopathy due to warfarin in patients with major bleeding was traditionally reversed with fresh frozen plasma and intravenous (IV) vitamin K, but prothrombin complex concentrates (PCC) are increasingly used in the treatment of these patients. Factor Eight Inhibitor Bypassing Activity (FEIBA) is an activated four-factor PCC most commonly used in patients with hemophilia. We aimed to evaluate the efficacy and safety of FEIBA and IV vitamin K for the reversal of warfarin-associated coagulopathy in patients with major bleeding, by measuring the percentage of patients who achieved target INR ≤ 1.5 and the incidence of thrombotic adverse events (TAE).Methods: In this prospective observational study, we enrolled patients presenting to the Emergency Department (ED) with warfarin associated coagulopathy (INR > 1.5) and major bleeding. Patients received FEIBA using an INR based dosing strategy and IV vitamin K.Results: In 43 patients, median initial INR was 4.0 (2.7, 7.3 interquartile range (IQR)). Median time to result the second INR was 45 min (38, 55 IQR) and the median INR was 1.4 (1.3, 1.6 IQR). Out of the 43 patients, 93% achieved the target INR of ≤1.5. In-hospital mortality was 40% (17 patients). There were 11 TAEs in 6 patients (14%); 4 events in 2 patients (5%) were attributed to FEIBA.Conclusion: A protocolized use of FEIBA and IV vitamin K resulted in the efficacious reversal of warfarin-induced coagulopathy in patients with major bleeding. TAEs occurred in 14% of patients and were attributed to FEIBA in 5% of patients. [ABSTRACT FROM AUTHOR]

Objective: In January 2018, Roche Diagnostics calibrated CoaguChek XS PT Test Strips to the latest World Health Organization reference preparation. On September 12, 2018, Roche Diagnostics issued an urgent medical device correction statement warning of inaccurate international normalized ratio (INR) results greater than 4.5 and recommended additional confirmatory testing. Eight weeks later, on November 2, the U.S. Food and Drug Administration issued a class I recall of all affected lot numbers. The objective of this project was to determine the clinical effects of recalibration of CoaguChek on patients managed by the Anticoagulation Management Services (AMS).Methods: Two retrospective chart reviews were conducted for patients seen by AMS from May 1 to September 11 and from September 12 to November 2, 2018. Data collected included date of INR, confirmatory testing (if applicable), reason for elevated INR, and interventions. Data were analyzed using descriptive statistics.Results: From May 1 to September 11, 2018, 16 of 166 patients were affected by recalibrated strips, resulting in 19 of 1176 INRs being greater than 4.5. Almost half (47%) of elevations were due to unknown causes, and most were corrected by holding at least 1 dose. Of the 152 patients treated from September 12 to November 2, 8 patients were affected by the recalibration, resulting in 11 of 453 INRs being greater than 4.5. Six resulted in confirmatory INR testing with an average difference of 2 points. No bleeding events or hospitalizations were reported in either group.Conclusion: Based on the experiences of 1 anticoagulation clinic, the CoaguChek XS PT Test Strip calibration update and class I recall did not result in a meaningful clinical impact. [ABSTRACT FROM AUTHOR]

Experimental studies have shown that disinfection byproducts (DBPs) induce coagulotoxicity, but human evidence is scarce. This study aimed to explore the relationships of DBP exposures with blood coagulation parameters. Among 858 women from the Tongji Reproductive and Environmental (TREE) study, urinary dichloroacetic acid (DCAA) and trichloroacetic acid (TCAA) were detected as internal biomarkers of DBP exposures. We measured activated partial thromboplastin time (APTT), fibrinogen (Fbg), international normalized ratio (INR), prothrombin time (PT), and thrombin time (TT) as blood coagulation parameters. Multivariable linear regression models were utilized to estimate the relationships between urinary DCAA and TCAA and blood coagulation parameters. The effect modifications by demographic and lifestyle characteristics were further explored. Elevated tertiles of urinary DCAA concentrations were associated with increased PT and INR (11.29%, 95% CI: 1.66%, 20.92% and 0.99%, 95% CI: 0.08%, 1.90% for the third vs. first tertile, respectively; both P for trends < 0.05). Stratification analysis showed that the positive associations were only observed among younger (< 30 years), leaner (body mass index < 24.0 kg/m2), and non-passive smoking women. Moreover, elevated tertiles of urinary TCAA concentrations in positive associations with PT and INR were observed among younger women (17.89%, 95% CI: 2.50%, 33.29% and 1.82%, 95% CI: 0.34%, 3.30% for the third vs. first tertile, respectively; both P for trends < 0.05) but not among older women (both P for interactions < 0.05). Higher levels of urinary DCAA and TCAA are associated with prolonged clotting time among women. [Display omitted] • Associations of DBP exposures with blood coagulation parameters were explored firstly. • Urinary DCAA was associated with increased PT and INR. • Age modified the associations of urinary TCAA with PT and INR. • Urinary TCAA in positive associations with PT and INR occurred in younger women. [ABSTRACT FROM AUTHOR]

The article discusses that coordination between the atria and ventricles, often at rapid heart rates. It mentions that Atrial fibrillation (AF) is associated with significant morbidity and mortality, leading to a 1.5-2 fold increase in the risk of death; and AF is also strongly linked with non-cardioembolic stroke as a result of large vessel atherosclerosis, which may also be related to a systemic inflammatory state.

Background: Studies have shown that the concomitant use of a vitamin K antagonist (VKA) and an antiplatelet (APL) drug increased the bleeding risk and was less effective at preventing ischemic events. This study aimed to investigate the control status of international normalized ratio (INR) and the discontinuation rate of a VKA in patients taking VKA plus an APL drug compared with those taking a VKA alone. Methods: Data were extracted from the KORean Atrial Fibrillation Investigation II registry, a multicenter noninterventional prospective observational study. Nonvalvular atrial fibrillation (NVAF) patients with CHADS2 scores ≥ 1 who newly started (within 3 months) a VKA were enrolled and followed up for 1 year. Results: A total of 866 NVAF patients (mean age, 67.7 years; 60.3% men) without a bleeding history were divided into the VKA+APL (n = 229) and VKA alone (n = 637) groups. During follow‐up, mean INR level was lower in the VKA+APL group than in the VKA alone group (1.7 ± 0.8 vs 1.9 ± 0.9, P = 0.0005). INR levels were poorly controlled in both groups (66.1% and 64.7%, respectively). Patients in the VKA+APL group more frequently discontinued VKA than patients in the VKA alone group (28.8% vs 24.2%, P = 0.045). Major causes of VKA discontinuation were uncontrolled INR level and patient dissatisfaction or concerns. Conclusions: The conditions of NVAF patients were inadequately controlled with VKA with or without an APL. These findings suggest that other antithrombotic treatment options are warranted in NVAF patients to achieve INR control. [ABSTRACT FROM AUTHOR]

Introduction: For reversal of warfarin-induced coagulopathy, FDA labeling of four-factor prothrombin complex concentrate (4F-PCC) endorses a dosing strategy based on body weight and baseline INR. Recent literature suggests lower, fixed doses of 4F-PCC may be equally efficacious. The present evaluation aims to characterize the relationship between 4F-PCC dose and degree of reduction in INR.Methods: This is a retrospective, single-center review of 4F-PCC administrations for warfarin reversal between May 2014 and August 2017. The primary endpoint evaluates the relationship between doses of 4F-PCC and INR measurement after reversal, represented as a linear regression. Exploratory endpoints characterize the relationships of both body weight and baseline INR, the components determining initial 4F-PCC dose, with INR after reversal. Additionally, for records presenting with an INR of 2-3.9, mean INR after reversal was characterized as a function of two 4F-PCC dose cohorts (< 30 and ≥30 IU fIX/kg).Results: A significant linear relationship between 4F-PCC dose and INR after reversal (INR after 4F-PCC = 1.3651-0.00004(4F-PCC Dose), p = 0.0071, R2 = 0.0630) was observed. Body weight and baseline INR were not correlated with INR after reversal. The subgroup analysis of records with presenting INR of 2-3.9 demonstrated no difference in mean INR after reversal with 4F-PCC for those receiving <30 IU fIX/kg and those receiving ≥30 IU fIX/kg.Conclusion: This evaluation found no clinically relevant relationship with 4F-PCC doses and degree of INR reversal. Further prospective study is required to determine optimal dosing schemes of 4F-PCC for warfarin reversal. [ABSTRACT FROM AUTHOR]

Copyright of Revista Española de Cardiología (18855857) is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Introduction : Les antivitamines K (AVK) sont prescrits chez les porteurs de prothèses cardiaques mécaniques. Le traitement est marqué par une marge thérapeutique étroite et un important risque hémorragique et thrombotique. Depuis quelques années, le temps passé dans la zone thérapeutique (TTR) est considéré comme gold standard pour évaluer l'efficacité d'un traitement par les AVK. Notre objectif était d'évaluer la stabilité de l'INR au cours du temps et les facteurs qui contribuent à son instabilité chez les patients sous AVK en utilisant comme indicateur TTR. Matériel et méthodes : C'est une étude rétrospective descriptive réalisée au CHU Habib Thameur de Tunis sur trois ans. Ont été inclus les patients porteurs de prothèses cardiaques mécaniques. Les INR ont été relevés sur une période de six mois. La méthode de Rosendaal a été utilisée pour calculer le TTR. Un traitement efficace est défini par un TTR > 70 %. Résultats : 31 patients ont été inclus avec un sex-ratio M/F = 0,29 et un âge moyen égal à 58,54 ±10,14 ans. La valeur moyenne du TTR était de 36,49 ± 20,91 ans. Le TTR était < 70 % chez 93 % des patients. Seul le nombre de médicaments supérieur ou égal à 3 était associé de manière significative à un TTR < 70 % en analyse mulitivariée. Conclusion : L'équilibre du traitement par les AVK n'était pas satisfaisant au cours de notre étude. Nos résultats soulignent l'intérêt de la mise en place d'outils d'amélioration de l'équilibre des AVK adaptés à notre population afin d'assurer la meilleure compréhension et adhésion au traitement. Introduction: Vitamin K antagonists (VKA) are prescribed in patients with a cardiac prothesis. Their use is difficult because of a narrow therapeutic margin and a major hemorrhagic and thrombotic risk. In recent years, the time spent in the therapeutic zone (TTR) is considered as the "Gold Standard" for evaluating the effectiveness of a treatment by VKA. The aim of our study was to assess the stability of INR over time and the factors contributing to its instability in patients on VKA using TTR as an indicator. Material and methods: We conducted retrospective descriptive study at Habib Thameur University Hospital in Tunis over a period of three years. Patients with mechanical heart prostheses whose monitoring of VKA treatment were included. INRs were reported over a six-month period. The Rosendaal method was used to calculate the TTR. Effective treatment is defined by a TTR > 70 %. Results: 31 patients were included with a sex ratio M / F = 0.29 and an mean age of 58.54 ± 10.14 years. The mean TTR value was 36.49 ± 20.91 years. TTR was less than 70 % in 93 % of patients. Only the number of drugs received greater than or equal to 3 was significantly associated with a TTR < 70 % in multivariate analysis. Conclusion: The balance of AVK treatment was not optimal to be considered effective. Our results underline the importance of setting up tools to improve the balance of VKA adapted to our population in order to ensure better understanding and adherence to treatment. [ABSTRACT FROM AUTHOR]

Abstract Background/purpose Tranexamic acid (TA) is one of the commonly used local hemostatic agents for dental procedures and a previous study has demonstrated a significantly lower incidence of post-procedural bleeding (PPB) in patients taking warfarin and received local TA treatment after the dental procedures than those who took warfarin and did not receive local TA treatment. However, it is still unknown whether post-procedural local TA treatment can lower the bleeding risk to the same level as individuals who do not take oral anticoagulant (OAC). The current study aimed to compare the PPB risk in patients who took OAC and received local TA treatment after the dental procedures and individuals who did not take OAC and underwent similar dental procedures. Materials and methods We systematically searched primary researches from two databases and four eligible cohort studies were identified. The bleeding incidence was collected from each study and the pooled odds ratio (OR) and 95% confidence interval (CI) of PPB were calculated using Mantel-Haenzel method. Results The analysis revealed a higher risk of PPB in patients who took OAC and received local TA treatment after the dental procedures than individuals who did not take OAC and underwent similar dental procedures with the pooled OR of 2.4, although the pooled effect estimate had a relatively wide 95% CI with non-statistically difference (0.69–8.12). Conclusion This study results serve as a reminder to dentists that the increased risk of PPB in those who took OAC is not entirely resolved by the local TA treatment. [ABSTRACT FROM AUTHOR]

Background/purpose: Warfarin treatment benefits vary with the clinical skill of warfarin dosage adjustment. However, optimal dosage adjustment in response to the out-of-range international normalized ratio (INR) is not completely understood.Methods: Data for 2014-2016 from an integrated health care information system of a single hospital were analyzed. Based on their warfarin dosage fluctuation (WDF), defined as the standard deviation of all prescribed warfarin dosages divided by the mean dosage, the patients were classified into Groups 1 (0-0.10), 2 (0.10-0.20), and 3 (>0.20). Target and in-range INRs were 2.0-2.5 and 1.5-3.0, respectively. Based on time in therapeutic range (TTR), patients were also categorized into Groups 1 (<0.6), 2 (0.6-0.9), and 3 (>0.9). The primary outcome was emergency department visits for bleeding or thromboembolism (TE) events.Results: Eighty-three events were retrieved from 17,397 records (1834 patients). Annual incidence rates were 0.9%, 2.5%, and 4.5% for WDF Groups 1, 2, and 3, respectively (p < 0.05), and 2.3%, 1.7%, and 1.7% for TTR Groups 1, 2, and 3, respectively (p = 0.41). Area under the receiver operator characteristic curves for WDF and TTR were 0.686 and 0.519, respectively, indicating that WDF exhibited superior predictive performance than TTR.Conclusion: High WDF rather than low TTR was associated with increased bleeding and TE incidence rates. [ABSTRACT FROM AUTHOR]

Warfarin therapy requires maintenance of a therapeutic international normalized ratio (INR) and thus requires routine monitoring to ensure benefits of anticoagulation, while avoiding complications. As the pharmacist's role evolves from traditional medication dispensing towards direct patient care, many anticoagulation management services are pharmacist-managed. Due to the coronavirus disease 2019 (COVID-19) pandemic, healthcare providers were faced with re-evaluating anticoagulation management practices to minimize person-to-person exposure risk. Although being anticoagulated is not considered high risk for illness from the coronavirus, these patients are often of advanced age and frequently have multiple comorbidities, putting them at increased risk. Consequently, two hospital-based, pharmacist-managed outpatient anticoagulation management services developed drive-thru curbside clinics to continue providing care to warfarin patients. The services utilized universal COVID-19 precautions to conduct curbside appointments where pharmacists determined patient's warfarin therapy plan, scheduled timely follow-up, and provided dosing instructions. With the unexpected coronavirus outbreak, this immediate change to traditional anticoagulation management was essential for safe and effective anticoagulation therapy. Implementing a curbside clinic allowed for safe distancing while managing warfarin appropriately. [ABSTRACT FROM AUTHOR]

Background: Available evidence suggest that the optimum prothrombin time-international normalised ratio (PT-INR) intensities recommended for anticoagulation of patients with mechanical heart valve prosthesis may not apply to all race groups. Optimal PT-INR target ranges and effectiveness of warfarin oral anticoagulation were determined among black South African patients fitted with St Jude bileaflet mechanical heart valve prosthesis (SJBMHVP) at Dr George Mukhari Academic Hospital (DGMAH). Methods: A convenience sample of 95 medical records of patients fitted with SJBMHVP from 1994 until 2013 was reviewed. Optimum PT-INR target ranges were estimated using two different methods: the classical two PT-INR target level method and the alternative, PT-INR specific incident rate method. The quality of warfarin anticoagulation was assessed using the fraction in therapeutic range method. Results: Optimum PT-INR target ranges for all participants fitted with SJBMHVP in the aortic position was estimated to be 2.0-3.5 and 2.6-3.5, respectively, by the classical and alternative methods. That of the patients with mitral valve replacement was estimated to be in the range 2.6-3.5 by the classical method and that of patients with double heart valve replacement was estimated to be < 3.5 by both methods. The quality of warfarin anticoagulation of participants with SJBMHVP replacement was found to be inadequate as indicated by percentage time in treatment range (TTR) of 49.7% for all study participants compared with the ideal TTR of 70% and above. Conclusion: Optimum Caucasian-based PT-INR intensities recommended for oral anticoagulation of patients fitted with mechanical heart valve prosthesis are applicable to black patients fitted with SJBMHVP at DGMAH. [ABSTRACT FROM AUTHOR]

Copyright of Chinese Journal of Lung Cancer is the property of Chinese Journal of Lung Cancer and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Pharmacist managed warfarin clinics can improve the anticoagulation status of non-valvular patients. The first of such services was implemented at the Cornwall Regional Hospital in Jamaica in 2013. Objectives: To assess the anticoagulation control of patients on warfarin therapy over six months in the pharmacist managed warfarin clinic at Cornwall Regional Hospital. Methods: Retrospective docket review for the period January 2014 to December 2016 was done to include data of patients attending routine clinic appointments for at least six months. Age, gender, date of visit, indication for warfarin therapy, warfarin dose and International Normalized Ratio readings were extracted. Percentage time spent in therapeutic range (TTR) was calculated by month for six months using the Rosendaal linear interpolation method. Patient anticoagulation status was categorized as poor (TTR<40%), moderate (TTR=40-64%) or good (TTR≥65%) and anticoagulation status at three months and six months was compared. Results: For the period of assessment, 52 patients were identified; the median age was 58 years and 36 patients were males. Deep vein thrombosis was the main indication for therapy (22 of 52) and median warfarin weekly dose ranged was 15.0-130 mg. At time of recruitment most of the patients were outside the target INR range (43 of 52). Within one month, the median TTR attained was 31% [IQR 62-10]. This significantly improved by second month to 60% [IQR 82-23] (p=0.001). By month three, the proportion of patients in good, moderate and poor anticoagulant status was 19/51, 15/51 and 17/51 respectively, which at six months changed to 23/51, 12/51. 16/51 respectively; thus, although coagulation status improved from month one to three, there was no significant improvement from month three to month six (p=0.31). Conclusions: The pharmacist managed warfarin clinic monitoring services were successful in attaining TTRs >40% and sustaining these values over six months. The services should therefore be encouraged. [ABSTRACT FROM AUTHOR]

BACKGROUND: The pneumonia 30-d readmission rate has been endorsed by the National Quality Forum as a quality metric. Hospital readmissions can potentially be lowered by improving inhospital care, transitions of care, and post-discharge disease management programs. The purpose of this study was to create an accurate prediction model for determining the risk of 30-d readmission at the point of discharge. METHODS: The model was created using a data set of 1,295 hospitalizations at the Cleveland Clinic Main Campus with pneumonia over 3 y. Candidate variables were limited to structured variables available in the electronic health record. The final model was compared with the Centers for Medicare and Medicaid Services (CMS) model among subjects 65 y of age and older (n = 628) and was externally validated. RESULTS: Three hundred thirty subjects (25%) were readmitted within 30 d. The final model contained 13 variables and had a bias-corrected C statistic of 0.74 (95% CI 0.71- 0.77). Number of admissions in the prior 6 months, opioid prescription, serum albumin during the first 24 h, international normalized ratio and blood urea nitrogen during the last 24 h were the predictor variables with the greatest weight in the model. In terms of discriminative performance, the Cleveland Clinic model outperformed the CMS model on the validation cohort (C statistic 0.69 vs 0.60, P = .042). CONCLUSIONS: The proposed risk prediction model performed better than the CMS model. Accurate readmission risk prediction at the point of discharge is feasible and can potentially be used to focus post-acute care interventions in a high-risk group of patients. [ABSTRACT FROM AUTHOR]

The incidence of geriatric traumatic brain injury (TBI) is increasing throughout the United States, with many of these patients taking anticoagulation (AC) medication. The purpose of this investigation was to determine the effect of time to international normalized ratio (INR) reversal on intracranial hemorrhage evolution in TBI patients taking prehospital AC medication. We hypothesized that rapid reversal of INR improves outcomes of head-injured patients taking AC medication. Admissions to a Level II trauma center between February 2011 and December 2013 were reviewed. Patients presenting with an initial INR of 2.0 or more, computed tomographic scan positive for intracranial hemorrhage, and INR reversal to less than 1.5 in hospital were included. Patients with nontraumatic intracranial hemorrhage were excluded. Reversal of INR was achieved using some combination of fresh frozen plasma, prothrombin complex concentrate, and vitamin K. A binary logistic regression model assessed the adjusted impact of rapid INR reversal on intracranial hemorrhage evolution. Significance was defined as p < .05. One hundred subjects were included. Four patients with nontraumatic intracranial hemorrhage were excluded, resulting in a final study population of 96 patients. The most common intracranial hemorrhage in the study population was subarachnoid hemorrhage (71.9%), followed by subdural hemorrhage (35.4%). Reversal of INR of less than 5 hr was not associated with intracranial hemorrhage evolution; however, reversal of less than 10 hr was found to be associated with a decreased odds ratio for intracranial hemorrhage evolution ( p = .043). Rapid reversal of elevated INR levels ( <10 hr) may decrease intracranial hemorrhage evolution in TBI patients taking prehospital AC medication. [ABSTRACT FROM AUTHOR]

The objective of this research was to study the possible relationship between the consumption of dicoumarinic agents (understanding the consumption of acenocoumarol as regulated and monitored anticoagulation) and the mortality rate in people older than 65 years undergoing a hip fracture (HF) intervention. It was a retrospective, observational and descriptive study. Nine hundred fifty-seven patients were included who underwent an intervention for HF between the years 2012 and 2014 in a third-level hospital. Patients took acenocoumarol (16.1%), which compared with nonanticoagulated patients took longer in receiving intervention, they remained hospitalized for more days, and they presented greater mortality within the first year after the intervention. Likewise, those who presented greater risk according to the classification system used by the American Society of Anesthesiologists (ASA) to estimate the risk of anesthesia for the different states of the patients who were anticoagulated also suffered greater mortality. The next factors increased the mortality in the first year: advanced age, delayed surgery, male sex, need for transfusion, high international normalized ratio, consumption of acenocoumarol, and a high ASA risk. We concluded the consumption of acenocoumarol increased the risk of mortality within the first year after surgery in 1.3 of possible cases. Other risk factors that also independently increased the risk of mortality included advanced age, male sex, delayed surgery, the need for transfusions, and surgical risk (for high levels in the ASA classification). [ABSTRACT FROM AUTHOR]

Venous thromboembolism (VTE) can present in a variety of different clinical settings and in a diverse, comorbid patient population, both of which will guide the clinician toward the appropriate therapeutic response. Patients who present with pulmonary embolism are at risk for hemodynamic instability, recurrence of VTE, cardiac comorbidities, and increased risk of overall mortality. Prognostication models have been clinically validated for risk stratification and prediction of mortality. Similar to pulmonary embolism, patients with deep vein thrombosis carry a higher risk of VTE recurrence and cardiac comorbidities. Consequently, VTE can be treated by a variety of methods such as anticoagulants or inferior vena cava filters, which bear their own risks and benefits. It is imperative that clinicians monitor patients for complications from VTE and the chosen therapy. [ABSTRACT FROM AUTHOR]

Purpose: The current study is designed in order to investigate the effect of nurse-led care (the supportive and educational measurements by nurses) on stability time in therapeutic range of INR in ischemic stroke patients receiving Warfarin. Method: In this quasi-experimental study, 80 ischemic stroke patients were investigated, 40 patients in experimental group and 40 in the control group referred to the nurse-based warfarin clinics affiliated to Shiraz University of Medical Sciences. The mean ± SD duration of the intervention was 144 ± 84 days. The patients based on the percentage stability time in the therapeutic range of INR were classified into 3 groups of good control (>75%), medium control (60-75%), and poor control groups (<60%). The results were analyzed using qui-square and independent t-test according to these categories. Results: 38 patients in the experimental group and 39 in the control group had the therapeutic range of INR 2-3. The percentage of the stability time in the therapeutic range of INR (mean ± SD) in the experimental group was 64.08% ± 18.7 and in the control group it was 44.58% ± 25.12 (P< 0.001).The percentage of total INRs within the therapeutic range was 52.5% in the experimental group and 40.6% in the control group (P = 0.001). Conclusions: In conclusion, using the stroke prevention guidelines, thrombotic therapy protocols and familiarity with patients' diagnosis and risk factors in the experimental group led to more patients' stability time (The time that patients could remain stable within the INR therapeutic range) in their therapeutic range of INR as the best indicator of clinical performance. [ABSTRACT FROM AUTHOR]

Polyunsaturated fatty acids such as omega-3 eicosapentaenoic acid and omega-6 docosahexaenoic acid, found in over-the-counter fish oil supplements, are often consumed for their beneficial, prophylactic, antiinflammatory effects. Although the mechanisms of action are not fully known, a diet rich in polyunsaturated fats may reduce the risk of hyperlipidemia, atherosclerosis, high low-density lipoprotein cholesterol levels, hypertension, and inflammatory diseases. Masked by its many benefits, the risks of omega-3 fatty acid supplementation are often underappreciated, particularly its ability to inhibit platelet aggregation and promote bleeding in patients taking anticoagulant medications. The following details the clinical case of an elderly patient taking warfarin and fish oil supplementation whose warfarin-induced coagulopathy could not be reversed after suffering blunt head trauma. [ABSTRACT FROM AUTHOR]

Introduction Oral anticoagulation with warfarin is indicated for patients with prosthetic heart valves. The effects of religious fasting during Ramadan month (in the Islamic calendar) on anticoagulation aren’t clear. Objectives To study the impact of Ramadan fasting on international normalized ratio (INR), quality of anticoagulation, dose of warfarin used and blood osmolarity. Methods 18 patients were followed-up prospectively for 3 months (pre- Ramadan, Ramadan and post-Ramadan months). Patients presented for weekly visits in which blood samples were obtained. Results No significant difference in INR and warfarin dose was found between Ramadan month, and months before and after it. The post-Ramadan INR was significantly larger than pre-Ramadan (p = 0.004). Blood osmolarity was significantly lower during Ramadan compared to pre- and post-Ramadan months. A significantly better quality of anticoagulation was noticed during Ramadan (p < 0.001). A significantly larger ratio of supratherapeutic INR values occurred in the post-Ramadan month (p < 0.05). A significantly larger ratio of infra-therapeutic INR values was noticed in the pre-Ramadan month (p < 0.05). Conclusion No significant difference in mean INR or warfarin dose was found and a better quality of anticoagulation was achieved during Ramadan. A tendency toward supra-therapeutic anticoagulation occurred after Ramadan, thus a closer follow up during this period may be reasonable. [ABSTRACT FROM AUTHOR]

Background: Knowledge about drug-drug interactions commonly arises from preclinical trials, from adverse drug reports, or based on knowledge of mechanisms of action. Our aim was to investigate whether drug-drug interactions were discoverable without prior hypotheses using data mining. We focused on warfarin-drug interactions as the prototype.Methods and Results: We analyzed altered prothrombin time (measured as international normalized ratio [INR]) after initiation of a novel prescription in previously INR-stable warfarin-treated patients with nonvalvular atrial fibrillation. Data sets were retrieved from clinical work. Random forest (a machine-learning method) was set up to predict altered INR levels after novel prescriptions. The most important drug groups from the analysis were further investigated using logistic regression in a new data set. Two hundred and twenty drug groups were analyzed in 61 190 novel prescriptions. We rediscovered 2 drug groups having known interactions (β-lactamase-resistant penicillins [dicloxacillin] and carboxamide derivatives) and 3 antithrombotic/anticoagulant agents (platelet aggregation inhibitors excluding heparin, direct thrombin inhibitors [dabigatran etexilate], and heparins) causing decreasing INR. Six drug groups with known interactions were rediscovered causing increasing INR (antiarrhythmics class III [amiodarone], other opioids [tramadol], glucocorticoids, triazole derivatives, and combinations of penicillins, including β-lactamase inhibitors) and two had a known interaction in a closely related drug group (oripavine derivatives [buprenorphine] and natural opium alkaloids). Antipropulsives had an unknown signal of increasing INR.Conclusions: We were able to identify known warfarin-drug interactions without a prior hypothesis using clinical registries. Additionally, we discovered a few potentially novel interactions. This opens up for the use of data mining to discover unknown drug-drug interactions in cardiovascular medicine. [ABSTRACT FROM AUTHOR]

Background--We evaluated thrombotic and bleeding outcomes in patients with continuous-low left ventricular assist devices (CF-LVADs), stratified by anticoagulation intensity. Previous studies of outpatients with CF-LVADs have suggested that target international normalized ratio (INR) values <2.5 (range, 2-3) may be used. However, recent studies reported an increase in pump thrombosis among CF-LVADs, especially within the first 6 months of implant. Methods and Results--We retrospectively reviewed 249 outpatients at our center who received a CF-LVAD between January 2005 and August 2013. Using Poisson models, we analyzed their 10 927 INRs to determine INR-specific rates of thrombotic (ischemic stroke and suspected pump thrombosis) and hemorrhagic (gastrointestinal bleeding and hemorrhagic stroke) events occurring outside of the hospital. In multivariate analyses, we adjusted for age, sex, atrial fibrillation, coronary disease, and LVAD type as time-dependent Cox proportional hazard models. During a mean follow-up of 17.6±13.6 months, thrombotic events occurred in 46 outpatients. The highest event rate (0.40 thrombotic events per patient-year) was in the INR range of <1.5, but INR values of 1.5 to 1.99 also had high rates (0.16 thrombotic events per patient-year). INR was inversely associated with thrombotic events (hazard ratio, 0.40; 95% confidence interval, 0.22-0.72; P=0.002). The optimal INR based on weighted mortality of thrombotic and bleeding events was 2.6. Conclusions--INR is inversely related to thrombotic events occurring outside of the hospital among patients supported with CF-LVADs. INR values <2.0 increase the rate of thrombotic events occurring outside of the hospital among patients supported with CF-LVADs. [ABSTRACT FROM AUTHOR]