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To assess the effects of various concentrations of dexmedetomidine on the human blood coagulation profile using rotational thromboelastometry (ROTEM). Venous blood samples were collected from 11 healthy volunteers and divided into four specimen bottles; dexmedetomidine was added to attain final sample concentrations of 0, 0.5, 1.0, and 1.5 ng/mL. ROTEM was performed on each study sample. The concentration of dexmedetomidine increased, and the ROTEM values showed a hypercoagulable state. The change in clotting time (CT) for INTEM was larger in samples with a dexmedetomidine concentration of 1.5 ng/mL (− 34%) than in the 0.5 ng/mL samples (− 16%) (P = 0.010). The change in clot formation time (CFT) for INTEM was greater in 1.5 ng/mL samples (− 16%) than in 0.5 ng/mL samples (− 4%) (P = 0.004). A greater decrease in CT for EXTEM was identified in the 1.0 ng/mL and 1.5 ng/mL samples (− 36% and − 37%, respectively) than in the 0.5 ng/mL samples (− 12%) (P = 0.003 for both categories). The change in CFT for EXTEM was greater in the 1.0 ng/mL and 1.5 ng/mL samples (− 11% and − 13%, respectively) than in the 0.5 ng/mL samples (− 4%) (P = 0.006 and P = 0.001, respectively). A bigger change in maximum clot firmness (MCF) for EXTEM was observed in the 1.5 ng/mL samples (4%) than in the 0.5 ng/mL samples (0%) (P = 0.002). The change in MCF for FIBTEM was greater in the 1.5 ng/mL samples (19%) than in the 0.5 ng/mL samples (5%) (P = 0.001). All coagulation pathways showed a hypercoagulable state as the concentration of dexmedetomidine increased. Nevertheless, most of the values of ROTEM were maintained within the reference ranges. Clinical Trial NCT04269278.

Maximum clot firmness (MCF) is the main parameter of thromboelastography (TEG) reflecting the stability of a clot. In this work, we looked for markers that can influence the enhancement of MCF and detec­ted molecular markers and blood clotting parameters that can be involved in such mechanisms. Blood samples of pregnant women with placental disorders were collected in the Kyiv Perinatal Center. TEG was performed on whole blood in EXTEM and INTEM tests. APTT, INR, fibrinogen concentration and platelet aggregation were measured using traditional laboratory approaches. D-dimer was detected in sandwich ELISA using monoclonal antibodies III-3B and II-4D. The relative cross-linking activity of factor XIIIa was measured by the direct quantification of the cross-linked γ-chain of fibrin using Western-Blotting with monoclonal antibody II-4D. D-dimer and fibrinogen concentrations, clotting time in the APTT test, INR and rate of platelet aggregation did not correlate with the MCF. However, we found positive correlations of MCF with factor XIIIa activity: 0.51 and 0.87 for EXTEM and INTEM, respectively. These data indicate that for normal and slightly increased fibrinogen concentrations, fibrin clot firmness will depend mostly on the activity of factor XIIIa. Thus the direct determination of factor XIIIa activity in blood plasma of patients can be relevant for predicting the risk of intravascular coagulation. Evaluation of the content and activity of individual clotting factors or other components of the coagulation system can be useful additions to the TEG diagnostics and should not be neglected.

Patients with severe coronavirus disease-2019 (COVID-19) frequently have hypercoagulability caused by the immune response to the severe acute respiratory syndrome coronavirus-2 infection. The pathophysiology of COVID-19 associated hypercoagulability is not fully understood, but characteristic changes include: increased fibrinogen concentration, increased Factor VIII activity, increased circulating von Willebrand factor, and exhausted fibrinolysis. Anticoagulant therapy improves outcomes in mechanically ventilated patients with COVID-19 and viscoelastic coagulation testing offers an opportunity to tailor anticoagulant therapy based on an individual patient's coagulation status. In this narrative review, we summarize clinical manifestations of COVID-19, mechanisms, monitoring considerations, and anticoagulant therapy. We also review unique considerations for COVID-19 patients who are on extracorporeal membrane oxygenation.

Aims of the present study were to define reference intervals for viscoelastic analyses of canine haemostasis using the ROTEM® delta analyser, and as a secondary aspect to determine the precision (repeatability) of this method. Blood samples from 125 clinically healthy dogs were included. Measurements were performed with commercially available activating reagents (ex-tem, in-tem and kaolin solution) as well as without activation. Additional fourfold measurements were done in 3 of the normal blood samples and in 3 samples with haemostatic alterations to evaluate the precision of the method. Coefficients of variation (CVs) for most of the ROTEM variables were

One of the significant challenges to translation of intravenously administered nanomaterials has been complement-mediated infusion reactions which can be lethal. Slow infusions can reduce infusion reactions, but slow infusions are not always possible in applications like controlling bleeding following trauma. Thus, avoiding complement activation and infusion responses is essential to manage bleeding. We identified nanocapsules based on polyurethane as candidates that did not activate C5a and explored their PEGylation and functionalization with the GRGDS peptide to create a new class of hemostatic nanomaterials. Using the clinically relevant rotational thromboelastography (ROTEM), we determined that nanocapsules promote faster clotting than controls and maintain the maximum clot firmness, which is critical for reducing bleeding. Excitingly, these polyurethane-based nanocapsules did not activate complement or the major pro-inflammatory cytokines. This work provides critical evidence for the role of modulating the core material in developing safer nanomedicines for intravenous applications.

Background: Although respiratory distress syndrome (RDS) constitutes a postnatal risk factor for bleeding and thromboembolic events in neonates, few studies have addressed this issue. We aimed to evaluate the hemostatic profile of neonates with RDS using rotational thromboelastometry (ROTEM). Methods: An observational study was conducted from November 2018 to November 2020 in the NICU of General Hospital of Nikaia “Aghios Panteleimon”. Preterm and term neonates with RDS hospitalized in the NICU were included and EXTEM (tissue factor-triggered extrinsic pathway), INTEM (ellagic acid activated intrinsic pathway), and FIBTEM (with platelet inhibitor cytochalasin D) assays were performed at the onset of the disease. Results: A hypocoagulable profile was noted in neonates with RDS compared to controls, expressed as significant prolongation of EXTEM CT (clotting time) and CFT (clot formation time), lower EXTEM A10 (amplitude at 10 min), MCF (maximum clot firmness), and LI60 (lysis index). Furthermore, prolongation of INTEM CFT and FIBTEM CT, and decreased INTEM and FIBTEM A10 and MCF were found in neonates with RDS. Multivariable logistic regression analysis showed that RDS is an independent factor for the recorded alterations in ROTEM variables. Conclusions: RDS is associated with a hypocoagulable profile and greater hyperfibrinolytic potential compared to healthy neonates.

Background Rotational thrombo-elastometry (ROTEM®) is a point-of-care coagulation test. Reference ranges in non-labouring women have recently been established from a cohort of women presenting for elective caesarean delivery using the recommended minimum sample size of 120. This study aimed to present baseline parameters for labouring and non-labouring women and to compare the mean values of these ROTEM® parameters. Methods Ethical approval was granted for an opt-out recruitment approach for labouring women and written consent was obtained from non-labouring women (data published previously). ROTEM® testing was performed in these two cohorts at term gestation. Women with any condition affecting coagulation were excluded. ROTEM® Delta reference ranges were derived by calculating the 2.5 and 97.5 percentiles for INTEM/EXTEM/FIBTEM amplitude at 5 minutes (A5), coagulation time (CT), maximum clot firmness (MCF) and clot formation time (CFT). Results One hundred and twenty-one labouring and 132 non-labouring women met inclusion criteria. The mean values for selected ROTEM® parameters for labouring and non-labouring women respectively were: FIBTEM A5, 21.05 and 19.7 mm (P=0.008); EXTEM A5, 54.8 and 53.2 mm (P=0.025); and EXTEM CT, 52.2 and 53.7 s (P=0.049). Significant differences between the groups were observed in measures of clotting onset and clot firmness. Conclusions We demonstrated a significant decrease in the mean time-to-clotting onset in labouring women compared with non-labouring women. Mean values for measures of clot firmness were greater in labouring women. In comparison to previously established ROTEM® baseline parameters for non-labouring women, this study provides evidence that there is greater hypercoagulability in labouring women.

Oxidative stress is a potential mechanism involved in the pathogenesis of iron deficiency anaemia (IDA). Although a tendency for hypercoagulability has been reported in IDA, its underlying mechanism is yet to be elucidated. This study investigated the probable relationship between oxidative stress and hypercoagulability in children with IDA. This study included 57 children diagnosed with IDA (IDA group) between October 2016 and October 2017 in addition to 48 healthy children (control group). The maximum clot firmness (MCF) index, and clot formation time (CFT) index, which are indicators of hypercoagulability in rotational thromboelastometry assays [intrinsic TEM (INTEM) and extrinsic TEM (EXTEM)] derived from our previous study, were recorded. Total oxidant status (TOS), total antioxidant capacity (TAC) and oxidative stress index (OSI) were analysed from serum samples of the individuals. In IDA group, OSI and TOS levels were higher and TAC level was lower compared to the control group (P

Objective To conduct a comprehensive evaluation of coagulation profiles-via traditional and whole blood thromboelastometry tests-in coronavirus disease 2019 (COVID-19)-positive vs COVID-19-negative patients admitted to medical wards for acute pneumonia. Patients and Methods We enrolled all consecutive patients admitted to internal medicine wards of Padova University Hospital between 7 March and 30 April, 2020, for COVID-19-related pneumonia (cases) vs non-COVID-19 pneumonia (controls). A group of healthy individuals acted as baseline for thromboelastometry parameters. Results Fifty-six cases (mean age, 64±15 years; male/female, 37/19) and 56 controls (mean age, 76±11 years; male/female, 35/21) were enrolled. Cases and controls exhibited markedly hypercoagulable thromboelastometry profiles vs healthy individuals, mainly characterized by a significantly shorter propagation phase of coagulation (clot formation time) and significantly increased maximum clot firmness (P

The coagulopathy of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is well documented in adults, with increases in D-dimer and prothrombin time found to be strong predictors of mortality, and anticoagulation shown to decrease this mortality. Viscoelastic parameters such as elevations in maximum clot firmness (MCF) on rotational thromboelastometry (ROTEM) have correlated with a hypercoagulable state in adults with SARS-CoV-2. We report our experience in children infected with SARS-CoV-2, with noted elevations in D-dimer and MCF on ROTEM (indicating hypercoagulability). Exploration of viscoelastic testing to provide additional laboratory-based evidence for pediatric-specific risk assessment for thromboprophylaxis in SARS-CoV-2 is warranted.

Background: Cryopreserved platelet products can be stored for years and are mainly used in military settings. Following thawing, cryopreserved platelets are activated, resulting in faster clot formation but reduced aggregation in vitro, rendering their efficacy in bleeding unknown. Also, concerns remain on the safety of these products. The aim was to investigate the efficacy and safety of cryopreserved platelets in a rat model of traumatic hemorrhage. Study Design and Methods: After 1 hour of shock, rats (n = 13/group) were randomized to receive a balanced transfusion pack (1:1:1 red blood cell:plasma: platelet) made from syngeneic rat blood, containing either liquid stored platelets or cryopreserved platelets. Primary outcome was the transfusion volume required to obtain a mean arterial pressure (MAP) of 60 mmHg. Secondary outcomes were coagulation as assessed by thromboelastometry (ROTEM®) and organ failure as assessed by biochemistry and histopathology. Results: The transfusion volume to obtain a MAP of 60 mmHg was lower in animals receiving cryopreserved platelets (5.4 [4.1-7.1] mL/kg) compared to those receiving liquid stored platelets (7.5 [6.4-8.5] mL/kg, p < 0.05). ROTEM® clotting times were shorter (45 [41-48] vs. 49 [45-53]sec, p < 0.05), while maximum clot firmness was slightly lower (68 [67-68] vs. 69 [69-71]mm, p < 0.01). Organ failure was similar in both groups. Conclusions: Use of cryopreserved platelets required less transfusion volume to reach a targeted MAP compared to liquid stored platelets, while organ injury was similar. These results provide a rationale for clinical trials with cryopreserved platelets in (traumatic) bleeding.

Summary Viscoelastic assays such as TEG ® and ROTEM ® are increasingly used to guide transfusion of blood products. The EXTEM assay maximum clot firmness (MCF) is a ROTEM measure available after 25–29 min used to guide early decisions. EXTEM A10, the clot firmness at 10 min, is an accepted early surrogate, but investigators differ on whether A5, the clot firmness at 5 min, is acceptable. We re‐examined this in a retrospective observational analysis of 1146 trauma patients in one centre who had ROTEM data recorded. A5 and A10 both correlated well with maximum clot firmness, with Pearson coefficients of r = 0.92 and r = 0.96, respectively. The correlations of A5, A10 and maximum clot firmness with requirement for massive transfusion were all similarly high, with c‐stats of 0.87, 0.89 and 0.90, respectively. The correlations with mortality were also similar but weaker, with c‐stats of 0.67, 0.69 and 0.69, respectively. Using a previously validated cut‐off of A5 < 35 mm to predict massive transfusion gave a sensitivity of 95%, specificity 83%, positive predictive value 9.3% and negative predictive value 100%. Using a value of A5 < 29 mm, for a pragmatic positive predictive value of 20%, gave a sensitivity of 67%, specificity 95% and negative predictive value 99%. Whether aiming for a high sensitivity or a strong predictive value, A5 was non‐inferior to A10 and actually missed fewer cases needing massive transfusion. A5 has similar utility to both A10 and maximum clot firmness as an early measure of clot firmness, and a low A5 value is strongly predictive of the need for massive transfusion.

Background Thromboelastometry may reduce red blood cell (RBC) transfusion in liver transplantation (LT). Fibrinogen concentration is a primary determinant of FIBTEM maximum clot firmness (MCF), but several factors could affect the correlation between FIBTEM MCF and fibrinogen values. We aimed to investigate (1) the concordance between fibrinogen level and FIBTEM MCF and (2) the association of fibrinogen level and FIBTEM MCF with RBC transfusion during LT. Methods A post hoc analysis of data from a randomized, multicentre, double-blind, saline/fibrinogen trial was used (NCT01539057). A total of 86 adult patients were included. Results The Lin concordance coefficient (LCC) between FIBTEM MCF and fibrinogen levels with the model formula 1·3679 + 0·05414* FIBTEM MCF was poor overall (LLC [95% CI]: 0·387 [0·340 to 0·432]) and moderate for the preperfusion period (LLC [95% CI]: 0·789 [0·747 to 0·824]), but very poor for the postreperfusion period (LLC [95% CI] 0·170 [0·105 to 0·233]). The model assessed for RBC transfusion for FIBTEM MCF showed an area under the curve of 0·788 [0·745-0·832]. Patients with FIBTEM MCF values 8 mm during the LT procedure is associated with less RBC transfusion. FIBTEM MCF values over 10 mm could lead to unnecessary fibrinogen administration.

Background. Both fibrinogen level and rotational thromboelastometry (ROTEM®) are accurate tests to demonstrate a bleeding tendency. FIBTEM® is one type of ROTEM test to determine the function of fibrinogen. An advantage of FIBTEM is helping physicians make proper decisions for blood component transfusions. However, the correlation between fibrinogen level and FIBTEM is still unclear. Objective. The aim of this study was to demonstrate a correlation between maximum clot firmness (MCF) in FIBTEM and fibrinogen level in critical trauma patients. Methods. Data were retrospectively collected from 87 patients who visited the emergency department between May 2017 and January 2019 in Songklanagarind Hospital. Blood specimens were sent for both ROTEM evaluation and fibrinogen level. The data were analysed with STATA program version 12.1. Results. Eighty-seven patients were enrolled in the study over the 21-month period. The patients consisted of 73 males (83.9%) with a median age of 40 years. Seventy-three patients (83.9%) were still alive. The following equation from FIBTEM MCF was used to predict fibrinogen level: fibrinogen level = 138 + (15.2 × FIBTEM MCF) (Lin’s concordance correlation coefficient of 0.52, P<0.001). The results showed a good correlation of FIBTEM MCF to predict patients with hypofibrinogenemia (area under ROC curve = 0.81). Patients with normal fibrinogen levels received significantly fewer units of all types of blood components. Conclusion. FIBTEM MCF had poor prediction of fibrinogen level; however, it can help to identify patients who have hypofibrinogenemia.

The study objectivs were to evaluate the correlation between platelet count (PLT) and rotational thromboelastometry (ROTEM) parameters and to determine ROTEM cut-off values for identification of thrombocytopenia in dogs. Medical records of 113 dogs with concurrent EXTEM (ROTEM activated by proprietary tissue factor), FIBTEM (EXTEM with added cytochalasin D) analysis and PLT were retrospectively reviewed. Signalment, treatment prior to analysis, hematocrit (HCT), EXTEM/FIBTEM maximum clot firmness (MCFEXTEM, MCFFIBTEM), EXTEM/FIBTEM maximum clot elasticity (MCEEXTEM, MCEFIBTEM) and EXTEM maximum lysis (MLEXTEM) were extracted from patient records and ROTEM database. Delta (Δ) MCF was calculated as MCFEXTEM−MCFFIBTEM and ΔMCE as MCEEXTEM−MCEFIBTEM. The PLT was correlated to MCFEXTEM, MCEEXTEM, ΔMCF and ΔMCE using Spearman-Rho analysis. Correlations were further analyzed in thrombocytopenic dogs. The ability to predict thrombocytopenia was evaluated with receiver operating characteristics (ROC). Thirty-seven samples (32.7%) showed thrombocytopenia ( 97% for all 4 parameters. In conclusion, PLT in dogs correlated moderately but significantly with all evaluated ROTEM parameters. All parameters were able to rule out thrombocytopenia

Background: Diagnostic tests for early allograft dysfunction (EAD) after living donor liver transplantation (LDLT) vary widely. We aimed to evaluate the predictive value of rotational thromboelastometry (ROTEM)-derived parameters in EAD. Materials and Methods: A total of 121 patients were reviewed. The definition of EAD proposed by Olthoff et al. included the presence of any of the following at postoperative day 7: bilirubin level ≥ 10 mg/dL, INR ≥ 1.6, or serum AST or ALT levels &gt, 2000 IU/L. All patients underwent ROTEM assay, which consisted of an extrinsically activated thromboelastometric test (EXTEM) before and 24 h after LDLT. Results: The 1-year/2-year OS were 68.%8/64.5% and 94.4%/90.8% for the EAD and non-EAD groups, respectively (p = 0.001). Two independent risks were identified for EAD, the postoperative clotting time (CT, p = 0.026) and time to maximum clot firmness (maximum clot firmness (MCF)-t, p = 0.009) on the EXTEM. CT yielded a specificity of 82.0% and negative predictive value of 83.0%, and MCF-t displayed a specificity of 76.4% and negative predictive value of 81.9% in diagnosing EAD. The use of the 24 h post-LDLT ROTEM increased the effectiveness of predicting overall survival (OS) compared to using the Olthoff’s EAD criteria alone (p &lt, 0.001). Conclusion: We conclude that CT and MCF on EXTEM were independent predictors of EAD. The 24 h post-LDLT ROTEM can be used with conventional laboratory tests to diagnose EAD. It increases the effectiveness of predicting OS.

Hemorrhage is the leading cause of preventable death in military conflicts. Different types of hemostatic dressings have been compared in animal studies for their ability to control bleeding. However, the effects of hemostatic agents in animals may be different from those in humans. The aim of this study was to assess the efficacy of hemostatic dressings in human blood.Clotting time, clot formation time, α-angle, maximum clot firmness, and lysis index of human blood incubated with QuikClot Gauze, Celox Gauze, QuikClot ACS+, and standard gauze, were compared using rotational thromboelastometry (ROTEM). Nonactivated, intrinsically activated, extrinsically activated, and fibrin-based ROTEM were used to elucidate different mechanisms of action of those dressings.QuikClot Gauze was the most efficacious hemostatic dressing, followed by Celox Gauze and standard gauze. QuikClot ACS+ was clearly outperformed.Modern hemostatic dressings such as QuikClot Gauze and Celox Gauze should be preferred to previous generations of hemostatic dressings, such as QuikClot ACS+. In vitro studies like ROTEM can provide valuable information about the mechanisms of action of hemostatic dressings. A combination of different mechanisms of action may increase the efficacy of hemostatic dressings.

Background To prevent the spread of drug-resistant bacteria, a rapid and accurate antimicrobial susceptibility test (AST) is necessary. Recently, morphokinetic microscopy approaches have been reported as a rapid AST method. However, these still require several hours to obtain a minimum inhibitory concentration (MIC). Adenosine triphosphate (ATP) luminescence has also been reported as a rapid AST method that can detect bacterial growth more rapidly than morphokinetic approaches, since ATP in bacteria increases prior to bacterial division. In this study, we designed a new machine learning-based algorithm that predicts MIC rapidly, using a dataset that contains ATP luminescence patterns and conventional MICs determined by turbidity. Essential agreement (EA) rates between rapid and conventional MIC were then evaluated. Methods Sixty-three strains of E. coli (ATCC 25922 and clinical isolates from Toyama University Hospital) were tested. Bacterial suspensions were diluted 500-fold in Mueller–Hinton broth from 0.5 McF solutions, and the final concentration of bacteria was 3×105 CFU/mL. The suspensions were dispensed into a 96-well microplate, which had 12 antimicrobials in two-fold dilution series, and the microplate was incubated at 35°C. At each measurement time point, the amount of ATP in a 10 μL aliquot from each well was evaluated by our original measurement system, which can sensitively detect ATP luminescence equivalent to a single bacterium. After 22 hours, MIC was determined conventionally by measuring turbidity. A rapid MIC for each bacterium was estimated by the algorithm based on the dataset consisting of the rest of the 62 strains (leave-one-out cross validation). Results Table 1 shows the EA rate for the 12 antimicrobials; EA rates > 90% were achieved for 7 antimicrobials in 2 hours and for 12 antimicrobials in 3 hours. In 6 hours, an average EA rate > 97% was achieved. Conclusion Using the dataset, our new machine learning-based algorithm predicted MIC rapidly within 2 hours with an EA rate > 90% for 7 antimicrobials. The rapid AST detected by the ATP luminescence method will contribute toward both appropriate antimicrobial treatment and reduction in medication and admission charges. In the future, other species of bacteria will be evaluated by our ATP method. Disclosures All authors: No reported disclosures.

Objective To evaluate blood coagulation using thromboelastometry in dogs following orthopedic surgery. Design Longitudinal observational study. Setting University veterinary teaching hospital. Animals Thirty-four adult client-owned dogs. Measurements and Main Results Dogs undergoing elective or emergency orthopedic surgery had whole blood collected before (T0), at 24 hours (T1), and 1 week (T2) after surgery. Whole blood from each dog was collected by jugular venipuncture using a 20-Ga needle and minimum venous stasis. The blood was placed into tubes containing 3.8% trisodium citrate (1 part citrate: 9 parts blood) and rested at 37°C. Coagulation was evaluated by means of thromboelastometry using the in-TEM, ex-TEM, and fib-TEM assays. Statistically significant increases (P < 0.05) in maximum clot firmness (MCF) from T0 to T1 in the in-TEM and fib-TEM profiles (both P = 0.0001), from T0 to T2 in the in-TEM, ex-TEM, and fib-TEM profiles (P = 0.012, P = 0.037, and P = 0.0001, respectively), and from T1 to T2 in the fib-TEM profile (P = 0.039) were noted. The α angle increased from T0 to T2 in the in-TEM and ex-TEM profiles (P = 0.019 and P = 0.036, respectively). All results were, however, within the institutional reference ranges. Conclusions In this study, unlike the hypercoagulability observed in human orthopedic patients, a hypercoagulable state as measured by thromboelastometry did not develop in dogs following orthopedic surgery.

FIBTEM parameters might predict the amount of postoperative hemorrhage following total knee arthroplasty (TKA), because fibrin polymerization and fibrinolysis have a central role in postoperative hemorrhage following TKA. This study retrospectively evaluated 54 patients who had undergone unilateral primary TKA. Laboratory coagulation parameters, including FIBTEM, were recorded before anesthesia induction and after admission to the postanesthetic care unit. The decrease in hemoglobin (Hb), amount of hemorrhage via closed suction drainage, fluid administration, and amount transfused were reviewed postoperatively. The preoperative FIBTEM amplitudes 10 (A10) and 20 (A20) minutes after clotting time and maximum clot firmness (MCF) had the highest correlations with the postoperative decrease in Hb (p = 0.001, p = 0.002, and p = 0.003, respectively). The preoperative FIBTEM A10 3.0 g/dL postoperative Hb decrement from the postanesthetic Hb value (p = 0.004, p = 0.007, and p = 0.012, respectively). Preoperative FIBTEM can predict the amount of postoperative hemorrhage following TKA.

Objective: To observe how a short vigorous exercise influences certain coagulation and fibrinolytic parameters in sportsmen and sportswomen.Design: Pre-post parallel-groups.Setting: Heart Centre and Department of Laboratory of Medicine, University Pecs, H-7623, HungaryParticipants: A total of 31 healthy individuals (mean age [+SD] 35 + 8 years; 18 males, 13 female), participated in the study at the Heart Centre of the University of Pecs. Participants were active and well-trained active sportsmen (and women) continuously involved in competitive sports activities (basketball, handball or water polo) for at least 10 years.Main Outcome Measures: All participants performed an exercise test on a cycle ergometer. Venous blood samples were obtained for rotational thrombelastometry (ROTEM).Results: In the case of sportsmen significant differences were obtained related to physical exercise in certain nonactivated thrombelastometry (NATEM) measurements. After exercise, the mean clotting time (CT) was shorter (329.3 ± 85.3 vs. 276.7 ± 91.7 seconds, P=0.041) and the maximum clot firmness (MCF) was broader (53.7 ± 4. vs. 60.4 ± 13.7 mm, P=0.034) than before exercise. In sportswomen mean CT was shorter (292.9 ± 65.2 vs. 247.8 ± 105.9 seconds, P=0.04), and the MCF was broader after exercise (59.0 ± 4.1 vs. 65.2 ± 9.7 mm, P=0.04) by NATEM measurements.Conclusions: A tendency for a post-exercise hypercoagulation state following a short-term strenuous exercise has been documented.

Prophylactic platelet concentrates transfusion represents a therapeutic choice in patients with chemotherapy-induced thrombocytopenia. This prospective, non-interventional study evaluated the effects of platelet concentrates transfusion on thromboelastometric parameters of platelet function in 36 transfusion occasions for 11 thrombocytopenic children undergoing chemotherapy. Pre- and posttransfusion (1-2 hours) blood samples were analyzed using standard coagulation tests and thromboelastometry (ROTEM) measurements (EXTEM and FIBTEM tests). Platelet component of the clot was calculated based on the EXTEM and FIBTEM maximum clot elasticity (MCE) results. After transfusion, mean platelet count increased from 16.5 × 109/L to 43.0 × 109/L ( P < .001) and platelet component increased from 34.1 to 73.0 ( P < .001). Statistically significant increases for posttransfusion EXTEM parameters A10, A20, and maximum clot firmness (MCF) were observed compared to pretransfusion values ( P < .001). The EXTEM α-angle values increased posttransfusion ( P < .05). The FIBTEM measurements were comparable pre- and posttransfusion. The study showed that platelet concentrates transfusion in thrombocytopenic children undergoing chemotherapy improves platelet-related coagulation pattern.

Viscoelastic tests such as functional fibrinogen polymerization assays (FFPAs) in thrombelastography (TEG(®)) or thromboelastometry (ROTEM(®)) measure the elasticity of extrinsically activated clotting under conditions of platelet inhibition. There are no reports on whether components of the FFPAs have any effects on fibrin polymerization, aside from the effects of platelet inhibition.Using various platelet-free plasma (PFP) preparations, we compared the extrinsically activated EXTEM thromboelastometric assay with 3 FFPAs: FIBTEM, FIBTEM PLUS, and the Functional Fibrinogen Test(®) (FFTEG). These FFPAs activate coagulation extrinsically but additionally inhibit platelet function. We used calibration plasma (Instrumentation Laboratory and Siemens), pooled fresh-frozen plasma (Octaplas) and freshly prepared PFP from a healthy volunteer. EXTEM and all FFPAs were run in parallel on a ROTEM device.Median (interquartile range) maximum clot firmness (MCF) values for all plasma preparations were: 20.5 mm (17.25-22.0 mm) in EXTEM, 23.0 mm (18.5-24.0 mm) in FIBTEM, 23.0 mm (18.25-24.75 mm) in FIBTEM PLUS, and 18.0 mm (16.0-19.0 mm) in FFTEG. Compared with EXTEM, FIBTEM and FIBTEM PLUS (P0.01) showed increased MCF values whereas FFTEG (P0.001) showed decreased MCF values. Further experiments in PFP showed that the platelet inhibitors used in the FFPAs (cytochalasin D or the glycoprotein-IIb/IIIa inhibitor abciximab) were not causing these alterations in MCF. However, reducing the activating tissue factor concentration (by diluting the extrinsic assay) decreased the MCF.We speculate that FIBTEM and FIBTEM PLUS may contain stabilizing agents that enhance fibrin polymerization whereas FFTEG might contain less tissue factor than the ROTEM assays.

To what extent haematocrit levels (Hct) and platelet counts (PLT) influence the measurement of parameters of thromboelastometry when assessed with the ROTEM® device is unclear. We investigated to what extent thromboelastometry measurements depend on Hct and PLT.Whole blood samples were taken for in-vitro preparations of mixtures with three different levels of PLT and a varying Hct. Maximum clot firmness (MCF), clotting time (CT), clot formation time (CFT) and alpha angle (α) for INTEM, EXTEM, FIBTEM and APTEM was recorded.Measurements depended substantially on Hct and PLT. MCF readings were systematically lower with increasing Hct (0.2 vs. 0.4: -7.8 (-8.3 to -7.2); p0.001, 0.2 vs. 0.55: -14.5 (-17.3 to -14.3); p0.001) but higher with increasing PLT (50 vs. 125×10(9)/l: 8.2 (4.2 to 12.3); p=0.005, 50 vs. 250×10(9)/l: 12.0 (7.2 to 16.8); p=0.002). CT readings were systematically higher with increasing Hct (0.2 vs. 0.4: 9.2 (6.2 to 12.1); p=0.001, 0.2 vs. 0.55: 38.2 (21.5 to 54.9); p=0.003) while increasing PLT had no influence. CFT readings were also systematically higher with increasing Hct (0.2 vs. 0.4: 83.8 (40.2 to 127.6); p=0.006, 0.2 vs. 0.55: 226.2 (110.7 to 341.7); p=0.006) but systematically lower with increasing PLT (50 vs. 125×10(9)/l: -144.0 (-272.3 to -15.6); p=0.036, 50 vs. 250×10(9)/l: -189.2 (-330.4 to -48.0); p=0.02); readings of the alpha angle showed a similar pattern.Our results suggest that readings of thromboelastometry parameters need to be adjusted by Hct and PLT to avoid potential confounding and miss-interpretations in clinical practice.

Background: We aimed to characterize the coagulation disturbances which may increase the risk of bleeding, thrombosis or death shortly after implantation of an extracorporeal membrane oxygenation (ECMO) or ventricular assist (VAD) device. Methods: Antithrombotic treatment was started in 23 VAD and 24 ECMO patients according to the hospital protocol. Additionally, conventional laboratory testing, rotational thromboelastometry (ROTEM®) and platelet function analysis (Multiplate®) were performed at predetermined intervals. Results: Four out of twenty-four (16.7%) of ECMO patients and 6/23 (26.1%) of VAD patients had severe bleeding after the procedure. When all the patients were analyzed together, low maximum clot firmness (MCF) in ExTEM and FibTEM analyses was associated with severe bleeding (pConclusion: Hypocoagulation shown by ROTEM® was associated with bleeding complications in patients with mechanical circulatory support. In contrast, hypercoagulation did not correlate with clinical thrombosis.

Introduction: Individuals with congenital afibrinogenemia can experience frequent and/or severe bleeding episodes (BE). Human fibrinogen concentrate (HFC) can correct the hemostatic defect and arrest bleeding. We investigated the efficacy, safety and pharmacokinetics (PK) of a new highly purified, double virus-inactivated HFC (Fibryga, Octapharma) in adolescent patients. Methods: Data were analyzed from two multinational, prospective, open-label studies. FORMA-01 studied the PK of the new HFC vs. comparator (Haemocomplettan P), as well as surrogate efficacy and safety, after single infusion of 70 mg/kg. Surrogate efficacy was defined as thromboelastometric maximum clot firmness (MCF). FORMA-02 was a Phase 3 study in which the primary endpoint was the hemostatic efficacy of the new HFC for on-demand treatment of the first bleeding event. A 4-point objective scale, which was adjudicated by an Independent Data Monitoring and Endpoint Adjudication Committee (IDMEAC), was used for evaluation of efficacy. In addition, MCF and safety were evaluated for all BEs that occurred during the study period. Results: Data were available for 12 patients aged 12-17 years with afibrinogenemia. FORMA-01 included 5 patients aged 12-17 years (1 was excluded due to a protocol deviation); PK data for new HFC vs. comparator are shown in Table 1. For comparison, in adults from the same study AUCnorm was also larger and clearance slower for new HFC vs. comparator (both p=0.0027). At 1 h following infusion of new HFC or comparator, mean±SD MCF (n=6) increased from 0 mm to 9.0±2.0 and 8.8±2.6 mm, respectively (9.9±3.3 and 10.4±4.9 mm in adults). In FORMA-02, 6 adolescent patients received new HFC individually dosed for treatment of a BE. Hemostatic efficacy for treatment of the first BE was rated as excellent for all patients (success: 100%; 90% CI: 0.655-1.000). When taking all BEs into account (n=23), efficacy was again classed as excellent for all patients. Mean MCF increased by 4.83±0.98 mm from baseline to 1 h after first infusion (7.06±3.36 mm in adults). There were no related serious adverse events, severe allergic, hypersensitivity reactions, or thromboembolic events, and no inhibitory anti-fibrinogen antibodies were detected. Conclusions: This analysis of data from two prospective studies demonstrated favorable efficacy, safety, and PK parameters of the new HFC in adolescents with afibrinogenemia. PK parameters were broadly comparable with those of the comparator HFC. After infusion of the new HFC, MCF increased statistically significantly and hemostatic efficacy was rated excellent in all patients. No safety concerns relating to the new HFC were identified in these study patients. Disclosures Peyvandi: Ablynx: Other: Member of Advisory Board, Speakers Bureau; Ablynx: Other: Member of Advisory Board, Speakers Bureau; Octapharma US: Honoraria; Ablynx: Other: Member of Advisory Board, Speakers Bureau; Octapharma US: Honoraria; Ablynx: Other: Member of Advisory Board, Speakers Bureau; Ablynx: Other: Member of Advisory Board, Speakers Bureau; Kedrion: Consultancy; Kedrion: Consultancy; Kedrion: Consultancy; Kedrion: Consultancy; Grifols: Speakers Bureau; Kedrion: Consultancy; Grifols: Speakers Bureau; Grifols: Speakers Bureau; Novo Nordisk: Speakers Bureau; Novo Nordisk: Speakers Bureau; Grifols: Speakers Bureau; Grifols: Speakers Bureau; Roche: Speakers Bureau; Novo Nordisk: Speakers Bureau; Roche: Speakers Bureau; Novo Nordisk: Speakers Bureau; Novo Nordisk: Speakers Bureau; Roche: Speakers Bureau; Shire: Speakers Bureau; Shire: Speakers Bureau; Roche: Speakers Bureau; Roche: Speakers Bureau; Shire: Speakers Bureau; Sobi: Speakers Bureau; Shire: Speakers Bureau; Sobi: Speakers Bureau; Sobi: Speakers Bureau; Shire: Speakers Bureau; Octapharma US: Honoraria; Sobi: Speakers Bureau; Sobi: Speakers Bureau; Octapharma US: Honoraria; Octapharma US: Honoraria. Schwartz:Octapharma US: Employment. Knaub:Octapharma AG: Employment.

Emicizumab is a factor (F) VIII(a) mimicking bispecific antibody to FIX(a) and FX, which is a new therapeutic agent for hemophilia A patients (PWHA) with inhibitor. Although the clinical effect and safety were confirmed in the clinical studies (NEJM 2016, NEJM 2017, Blood Adv. 2017), there exists difficulty in monitoring of emicizumab by APTT-based assay. In the present study, we challenged to establish a hemostatic monitoring system convertible to FVIII activity (FVIII:C) for PWHA under the emicizumab prophylaxis by utilizing non-activated rotational thromboelastometry (ROTEM). The studies were approved by local ethics committee and the informed consent was obtained from each patient. We firstly prepared the FVIII-deficient whole blood samples treated with a neutralizing anti-FVIII polyclonal IgG (30BU/mL), and compared the in vitro hemostatic response in the presence of emicizumab (0, 5 and 50µg/mL) spiked into these samples among three modes of ROTEM such as NATEM, EXTEM and INTEM. According to CaCl2 triggered-NATEM without any other activator, the sum of clot time and clot formation time (CT+CFT) was 1269 ± 197 sec (mean ± SD) for normal control and 6713 ± 855 sec for the samples without emicizumab. The value of CT+CFT was significantly shortened in the presence of emicizumab at 5 µg/ml and 50 µg/ml to 2157 ± 192 sec and 1521 ± 313 sec, respectively (p = 0.025). By contrast, measured by EXTEM utilizing tissue factor (0.5 pM) and CaCl2 as triggers, the values of CT+CFT for control, 0, 5 and 50 µg/mL of emicizumab were 552 ± 97 sec, 771 ± 186 sec, 658 ± 135 sec and 778 ± 90 sec, respectively. There was no significant difference (p = 0.44) among them. By INTEM, triggered by ellagic acid with CaCl2, the values of CT+CFT for control, 0, 5, and 50 µg/mL of emicizumab were 662 ± 202 sec, 5854 ± 705 sec, 951 ± 170 sec and 814 ± 216 sec, respectively. The value of CT+CFT was shortened in the presence of emicizumab, however, little difference was observed between two doses. The other parameters, maximum clot firmness and alpha angle, were not suitable for quantitative evaluation irrespective of the mode of measurement. These suggested that CT+CFT based on NATEM is a suitable parameter for the monitoring of emicizumab. In order to develop a NATEM-based hemostatic scale convertible to FVIII:C, we secondly measured CT+CFT in the samples (n = 81) from PWHA with various FVIII:C levels in our hospital. The samples were classified based on FVIII:C into three groups, such as Tertile (T)1 with undetectable FVIII:C ( By utilizing this NATEM scale, we investigated the hemostatic function of four PWHA with inhibitor (patient 1, 2, 3 and 5) and two without inhibitor (patient 4, 6) enrolled in the phase 1 study (ACE001JP) and its extension study (ACE002JP) with the different types of dosing-regimen (0.3, 1.0 and 3.0 mg/kg/week after loading dose) (Table). The baseline value of CT+CFT among all of the patients was 6502 ± 1297 sec in the range of T1-level classified as above. The value was shortened and maintained to T2-level at the concentration of ~10 μg/ml after emicizumab infusion at all three dosing. The value reached up to T3-level of ~20 μg/ml in 1.0 and 3.0 dosing groups. The hemostatic function reached up to T2- and T3-level during loading phase before achievement to the steady state. No joint bleeding was observed among the patients who achieved T3-level except for patient 5 and 6 who developed breakthrough bleedings in target joints. In conclusion, the global hemostatic function during emicizumab prophylaxis can be quantitatively evaluated by NATEM-based scaling before steady state among PWHA. Disclosures Yada: Shire Japan Co., Ltd.: Other: Teacher at a endowed course. Nogami:Chugai Pharmaceutical Co., Ltd: Consultancy, Membership on an entity's Board of Directors or advisory committees, Patents & Royalties: Anti-FIXa/X bispecific antibodies , Research Funding, Speakers Bureau. Kasai:Chugai Pharmaceutical Co., Ltd: Employment. Shima:Chugai Pharmaceutical Co., Ltd: Consultancy, Membership on an entity's Board of Directors or advisory committees, Patents & Royalties: Anti-FIXa/X bispecific antibodies , Research Funding, Speakers Bureau; F. Hoffmann-La Roche Ltd: Membership on an entity's Board of Directors or advisory committees.

Previous investigations in patients with coronary artery disease (CAD) revealed differences in thromboelastographic parameters indicating different states of coagulability. The aim of the present study was to investigate the coagulation status of patients with documented CAD and type II diabetes mellitus (DM) and non-diabetic patients with coronary artery disease with the PFA-100® and the ROTEM®. No differences were found in platelet function as measured with collagen/epinephrine (263.6 ± 70.6 s vs. 254.6 ± 65.3 s) and collagen/ADP cartridges (105.3 ± 63.2 s vs. 90.6 ± 47.3 s) in CAD patients with DM and CAD patients without DM. Measured with the EXTEM reagent of the ROTEM®, mean maximum clot elasticity (MCE) in patients with CAD and DM (233.6 ± 86.9) was significantly longer than in CAD patients without DM (186.7 ± 54.5), (p = 0.03). A similar result was seen using the INTEM reagent; patients with CAD and DM (234.4 ± 83.9) showed a higher value for MCE than CAD patients without DM (190.8 ± 57.8) which was of borderline significance (p = 0.053). Moreover, a weak trend for higher maximum clot firmness (MCF) was seen in CAD patients with DM compared with CAD patients without DM with the EXTEM reagent (68.1 ± 7.5 vs. 63.6 ± 8.6, p = 0.08) and the INTEM reagent (68.4 ± 7.2 vs. 64.1 ± 8.2, p = 0.09). The ROTEM® analysis indicates increased coagulability in patients with coronary artery disease and diabetes mellitus compared to non-diabetic CAD patients. Moreover, the ROTEM® device seems to be an appropriate and easy-to-use tool to describe the coagulation status in these patients groups.

Early clot amplitudes measured on thromboelastometry (ROTEM®) predict maximum clot firmness (MCF) in adults. In this multicentre, retrospective study, we aimed to confirm the suspected relationship between early ROTEM® variables and MCF, in children undergoing cardiac or non-cardiac surgery.4762 ROTEM® tests (e.g. EXTEM, INTEM, FIBTEM, APTEM, and HEPTEM) performed in children undergoing cardiac or non-cardiac surgery at three University hospitals between January 2011 and June 2014 were reviewed. To assess the correlation between clot amplitudes measured after 5, 10 and 15 min and MCF, each variable was compared with the corresponding MCF by calculating Spearman's correlation coefficient.For the EXTEM® test, we observed that amplitude measured after 5 min (A5: r=0.91, P0.001), 10 min (A10: r=0.95, P0.001) and 15 min (A15: r=0.96, P0.001) were strongly correlated to MCF. The same correlations were observed for INTEM® test (A5: r=0.93, P0.001; A10: r=0.97, P0.001; A15: r=0.97, P0.001), and FIBTEM® test (A5: r=0.93, P0.001; A10: r=0.94, P0.001; A15: r=0.96, P0.001). In addition, the amplitudes measured after five, 10 and 15 min were also strongly correlated with MCF in the APTEM® and the HEPTEM® tests. Receiver operating characteristics (ROC) analysis confirmed that A5, A10, A15 strongly predicted decreased MCF on all ROTEM® tests.This study confirmed that early values of clot amplitudes measured as soon as five, 10 or 15 min after clotting time could be used to predict maximum clot firmness in all ROTEM® tests.

Introduction Patients with multiple myeloma (MM) have an increased risk of thromboembolic events (TEE). Due to the complex nature of the prothrombotic state in MM, no single laboratory test has been designed to identify patients with the highest risk of developing TEE. Hence, this study is intended to assess the feasibility of using global hemostasis test rotation thromboelastometry (ROTEM) in MM patients to identify the presence of changes indicating hypercoagulability. Materials and Methods The study included 26 patients with MM at the time of diagnosis and 20 healthy volunteers. Clotting time (CT), clot formation time (CFT), alpha angle (α), maximum clot firmness (MCF) and maximum lysis (ML) were among the most important parameters recorded during the NATEM, INTEM, EXTEM, FIBTEM and APTEM tests. Results For the NATEM test, CT and CFT readings were markedly lower in MM patients than in controls (524 s v. 753 s; p = 0.0006 and 136 s v. 242 s; p = 0.02 respectively). However, no marked differences concerning these parameters were observed in the INTEM, EXTEM, FIBTEN or APTEM tests. α-angle values were significantly higher for MM samples according to the NATEM, EXTEM, FIBTEM and APTEM tests (64° v. 48.5°, p = 0.02; 77° v. 74°, p = 0.02; 80° v.69.5°, p = 0.00007; 77° v. 74°, p = 0.01 respectively). MCF readings were significantly higher in the FIBTEM test (22 mm v. 15.5 mm, p = 0.0003) in MM patients. Also, the NATEM test revealed a trend toward higher MCF values in MM samples (56 mm v. 49.5 mm, p = 0.055). No marked differences were seen in the INTEM, EXTEM and APTEM tests. ML readings were markedly lower (0 % v. 4.5 %, p = 0.0008) in MM samples than in controls according to the FIBTEM test. The studied clot lysis parameters did not differ markedly between analyzed groups in other tests. Marked negative correlations were noted between IgG concentration and CT (EXTEM, FIBTEM) and CFT (INTEM), as well as a significant positive correlation between IgG concentration and MCF (INTEM, FIBTEM) and α (INTEM) in MM IgG patients. Conclusions Our results suggest that patients with MM display changes in ROTEM tests at the time of diagnosis that may indicate a prothrombotic state.

Background Early detection of coagulopathy is important to prevent bleeding during liver transplantation (LT). Rotation thromboelastometry (ROTEM ® ) provides the earliest parameter of clot amplitudes at 5 min (A5). We evaluated whether A5 correlates with platelet count (PLT) and fibrinogen concentration (Fib) and can predict thrombocytopenia and hypofibrinogenaemia in hypocoagulable patients undergoing living-donor LT (LDLT). Methods A total of 3446 retrospective ROTEM ® measurements, including 1139 EXTEM, 1182 INTEM, and 1125 FIBTEM, with simultaneously measured PLT and Fib, were analysed during LDLT in 239 patients. The correlations between A5 and maximum clot firmness (MCF) index, PLT, and Fib were calculated. Receiver operating characteristic analysis with area under the curve (AUC) was used to assess A5 thresholds predictive of PLT and Fib. Results The median PLT was 47 000 mm −3 and the median Fib was 100 mg dl −1 during LDLT. The A5 parameters of EXTEM (A5 EXTEM ) and INTEM (A5 INTEM ) were highly correlated with MCF ( r =0.96 and r =0.95, respectively), PLT ( r =0.76 and r =0.77, respectively), and Fib ( r =0.63 and r =0.64, respectively). A5 of FIBTEM (A5 FIBTEM ) was also correlated with MCF ( r =0.91) and Fib ( r =0.75). A5 EXTEM thresholds of 15 and 19 mm predicted PLT −3 (AUC=0.90) and −3 (AUC=0.87), respectively, whereas A5 FIBTEM 4 mm predicted Fib −1 (AUC=0.86). Biases from A5 EXTEM and A5 FIBTEM to their MCFs were 16.4 and 1.3 mm, respectively. Conclusions A5 as an early variable of clot firmness is effective in detecting critically low PLT and Fib. A5 can therefore be a reliable fast index guiding transfusion therapy in hypocoagulable patients undergoing LDLT.

BACKGROUND The aim of this in-vitro pilot study was to assess the usefulness of the thrombelastograph ROTEM® for determining the anticoagulant activity of lepirudin. METHODS The ROTEM® parameters, clotting-time, clot formation time and maximum clot firmness were measured in the presence of increasing concentrations of lepirudin (10-4 μg/ml - 10 μg/ml). Citrated blood was obtained from 16 healthy male subjects. RESULTS Clotting-time increased from 79.1 ± 53.4 s at baseline to 194.1 ± 151.9 s at a drug concentration of 1μg/ml as measured with EXTEM (p < 0.0001). Borderline significance was found for the difference between maximum clot firmness at baseline (60.2 ± 4.3 mm) and after drug application (55.5 ± 6.5 mm). CONCLUSIONS This pilot investigation shows that the ROTEM® device may be suitable for monitoring lepirudin at low concentrations but the results should be confirmed in a larger study and the ROTEM® device validated against standard methods.

This study aimed to assess intrarater and interrater variability of coagulation point-of-care testing (POCT) using ROTEM delta operated by trained staff. Arterial blood samples were taken from 43 anesthetized piglets aged up to 6 weeks and weighing 4-6 kg. The following clotting measurements were recorded: clotting time, clot formation time (CFT), maximum clot firmness (MCF) and alpha angle using ROTEM delta assays ExTEM, InTEM, FibTEM and ApTEM. Intrarater variability was assessed when a single operator performed the same assay simultaneously in all four channels of the ROTEM device. Interrater variability was assessed by two different operators simultaneously performing the same assay. Variance components of the data were analyzed using linear mixed modeling. Three hundred and forty-three tests from 86 samples were loaded and analyzed. The intraclass correlation coefficient (ICC) was more than 0.7 for clotting measurements except for CFT and alpha in InTEM. For intrarater and interrater assessment, different relative variability for the ROTEM measurements were found with consistently higher variability for clotting time and CFT and lower variability of MCF and alpha angle. Interrater variability was not statistically significant as supported using Akaike's information criterion. Piglet coagulation testing using ROTEM delta showed a high ICC. Variability was significantly lower in MCF and angle alpha compared with clotting time and CFT. No further variability was added by a second user. Based on these data, ROTEM delta appears to be suitable as POCT.

Introduction: Although the pig is a standard model for the evaluation of various diseases in humans, including coagulopathy, it is not clear whether results in animals can be extrapolated to man. Materials and methods: In 75 anesthetized pigs, we assessed reagent-supported thrombelastometry (ExTEM®), platelet-blocked thrombelastometry (FibTEM®), and aprotinin thrombelastometry (ApTEM®). Results were compared to values from 13 anesthetized humans. Results (median, 95% CI): ExTEM®: While clot strength was comparable in pigs (66 mm, 65-67 mm) and in humans (64 mm, 60-68 mm; NS), clotting time in animals was longer (pigs 64 s, 62-66 s; humans 55 s, 49-71 s; P < 0.05) and clot formation time shorter (pigs 52 s, 49-54 s; humans 83 s, 67-98 s, P < 0.001). The clot lysis index at 30 minutes was lower in animals (96.9%, 95.1-97.3%) than in humans (99.5%, 98.6-99.9%; P < 0.001). ApTEM® showed no hyperfibrinolysis in animals. Modification of the anesthesia protocol in animals resulted in significant ExTEM® changes. FibTEM®: Complete platelet inhibition yielded significantly higher platelet contribution to clot strength in pigs (79%, 76-81%) than in humans (73%, 71-77%; P < 0.05), whereas fibrinogen contribution to clot strength was higher in humans (27%, 24-29%) than in animals (21%, 19-24%; P < 0.05). Conclusions: Maximum clot firmness is comparable in human and porcine blood. However, clot lysis, platelet and fibrinogen contribution to clot strength, as well as initiation and propagation of clotting, are considerably different between pigs and humans. In addition, anesthesic drugs seem to influence thrombelastometry in animals. Accordingly, coagulation abnormalities in pigs subjected to diseases may not necessarily represent the coagulation profile in sick patients. © 2011 Elsevier Ltd. All rights reserved. 128 5 477 482