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Thrombin Hemostatic

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21. Veraseal - human fibrinogen / human thrombin

pharmacodynamic studies and no studies on pharmacodynamic drug interactions were performed since FS Grifols’ components (Fibrinogen and Thrombin) are normal constituents of human plasma, which is agreed. Specific non-clinical conventional safety pharmacology studies of FS Grifols were not conducted, which is, due to the nature of the product, considered appropriate. Overall, the presented preclinical studies reveal evidence that FS Grifols will exert hemostatic effects as desired. 3.2.2. Pharmacokinetics (...) Veraseal - human fibrinogen / human thrombin 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged. 22 October 2015 EMA/674875/2015 Committee for Medicinal Products for Human Use (CHMP) Assessment report Veraseal International non

2015 European Medicines Agency - EPARs

22. Coagulation status of critically ill patients with and without liver disease assessed using a novel thrombin generation analyzer. Full Text available with Trip Pro

Coagulation status of critically ill patients with and without liver disease assessed using a novel thrombin generation analyzer. The liver synthesizes the majority of pro- and anti-coagulant and fibrinolytic proteins, and during liver dysfunction synthesis of these proteins is reduced. The end point of conventional hemostatic tests, such as the prothrombin time (PT), occurs when only 5% of thrombin generation (TG) has taken place and is not sensitive to the effects of natural anti-coagulants

2020 Journal of Thrombosis and Haemostasis

23. Therapeutic doses of recombinant factor VIIa in hemophilia generates thrombin in platelet-dependent and -independent mechanisms. (Abstract)

Therapeutic doses of recombinant factor VIIa in hemophilia generates thrombin in platelet-dependent and -independent mechanisms. In hemophilia bypass therapy, a platelet-dependent mechanism is believed to be primarily responsible for recombinant factor VIIa (rFVIIa)'s hemostatic effect. rFVIIa may also possibly interact with other cells through its binding to endothelial cell protein C receptor (EPCR) or cell surface phospholipids.We aim to investigate the relative contribution of platelet (...) -dependent and platelet-independent mechanisms in rFVIIa-mediated thrombin generation in hemophilic conditions at the injury site.Platelets were depleted in acquired and genetic hemophilia mice using anti-platelet antibodies. The mice were subjected to the saphenous vein injury, and the hemostatic effect of pharmacological concentrations of rFVIIa was evaluated by measuring thrombin generation at the injury site.Administration of anti-mouse CD42 antibodies to mice depleted platelets by more than 95

2020 Journal of Thrombosis and Haemostasis

24. Non-additive effect on thrombin generation when a plasma-derived factor VIII/von Willebrand factor (FVIII/VWF) is combined with emicizumab in vitro. Full Text available with Trip Pro

Non-additive effect on thrombin generation when a plasma-derived factor VIII/von Willebrand factor (FVIII/VWF) is combined with emicizumab in vitro. Emicizumab is an alternative non-factor approach for treating patients with hemophilia A. However, there is a potential risk of thrombotic events when emicizumab is concomitantly administered with pro-hemostatic therapies.To assess the hemostatic effect in vitro when a plasma-derived factor VIII concentrate containing von Willebrand factor (pdFVIII (...) /VWF) was added to hemophilia A plasma (HAp) in combination with emicizumab.HAp and HAp with FVIII inhibitors (HAp-i) samples with different concentrations of emicizumab (50 and 100 μg/mL) were combined with activated prothrombin complex concentrate at 0.5 to 1 U/mL, recombinant activated factor VII (rFVIIa) at 0.5 to 7 μg/mL, and pdFVIII/VWF at 0.1 to 4.5 IU/mL. Thrombin generation (TG; thrombin peak and endogenous thrombin potential) was determined using a Calibrated Automated Thrombogram

2020 Journal of Thrombosis and Haemostasis

25. Thrombin generation predicts for early recurrence in breast cancer patients. (Abstract)

Thrombin generation predicts for early recurrence in breast cancer patients. Cancer patients present with a hypercoagulable state often associated with poor disease prognosis.This study aims to evaluate whether thrombin generation (TG), a global coagulation test, may be a useful tool to improve the identification of patients at high risk of early disease recurrence (i.e. E-DR within 2 years) after breast cancer surgery.A cohort of 522 newly diagnosed patients with surgically resected high-risk (...) breast cancer were enrolled in the ongoing prospective HYPERCAN study. TG potential was measured in plasma samples collected before starting systemic chemotherapy. Significant predictive hemostatic and clinic-pathological parameters were identified in the derivation cohort by Cox-regression analysis. A risk prognostic score for E-DR was generated in the derivation and tested in the validation cohort.After a median observation period of 3.4 years, DR occurred in 51 patients, 28 of whom were E-DR. E-DR

2020 Journal of Thrombosis and Haemostasis

26. Controlled Multifactorial Coagulopathy: Effects of Dilution, Hypothermia, and Acidosis on Thrombin Generation In Vitro. (Abstract)

Controlled Multifactorial Coagulopathy: Effects of Dilution, Hypothermia, and Acidosis on Thrombin Generation In Vitro. Coagulopathy and hemostatic abnormalities remain a challenge in patients following trauma and major surgery. Coagulopathy in this setting has a multifactorial nature due to tissue injury, hemodilution, hypothermia, and acidosis, the severity of which may vary. In this study, we combined computational kinetic modeling and in vitro experimentation to investigate the effects (...) of multifactorial coagulopathy on thrombin, the central enzyme in the coagulation system.We measured thrombin generation in platelet-poor plasma from 10 healthy volunteers using the calibrated automated thrombogram assay (CAT). We considered 3 temperature levels (31°C, 34°C, and 37°C), 3 pH levels (6.9, 7.1, and 7.4), and 3 degrees of dilution with normal saline (no dilution, 3-fold dilution, and 5-fold dilution). We measured thrombin-generation time courses for all possible combinations of these conditions

2020 Anesthesia and Analgesia

27. Intravenous tranexamic acid versus topical thrombin in shoulder arthroplasty. (Abstract)

of stay (LOS) and 90-day readmission for each treatment group was obtained.283 TSA cases were included for final analysis. There was no statistically significant difference in the baseline characteristics with age, BMI or ASA. Postoperative Hgb (mg/dL) was higher in the group that received either IV TXA or thrombin compared to no hemostatic agents (p=0.001). Calculated blood loss in TSA was significantly higher in the group without hemostatic agents, 369.8 ml (59.5 SD) compared to IV TXA or topical (...) thrombin, 344.3 ml (67.1 SD) and 342.9 ml (65.6 SD) (p=0.03). Operative time was highest in the group that received no hemostatic agents, 2.3 hours (0.6 SD) (p=0.01). Transfusion rate for TSA treated with IV TXA or topical thrombin was equivalent (2.2%) but significantly lower than no intervention group (12%) (p=0.01). Odd's ratio for transfusion with IV TXA was 0.16 (95% CI 0.07-0.40, p = 0.001), and topical thrombin was 0.1 (95% CI 0.02-0.42, p = 0.02).Topical thrombin is an effective adjunct

2020 Journal of Shoulder and Elbow Surgery

28. Thrombin generation and bleeding in cardiac surgery: a clinical narrative review. (Abstract)

Thrombin generation and bleeding in cardiac surgery: a clinical narrative review. This narrative review discusses the role of thrombin generation in coagulation and bleeding in cardiac surgery, the laboratory methods for clinical detection of impaired thrombin generation, and the available hemostatic interventions that can be used to improve thrombin generation. Coagulopathy after cardiopulmonary bypass (CPB) is associated with excessive blood loss and adverse patient outcomes. Thrombin plays (...) a crucial role in primary hemostasis, and impaired thrombin generation can be an important cause of post-CPB coagulopathy. Existing coagulation assays have significant limitations in assessing thrombin generation, but whole-blood assays designed to measure thrombin generation at the bed-side are under development. Until then, clinicians may need to institute therapy empirically for non-surgical bleeding in the setting of normal coagulation measures. Available therapies for impaired thrombin generation

2020 Canadian Journal Of Anaesthesia

29. Pharmacodynamic monitoring of factor VIII replacement therapy in hemophilia A: combining thrombin and plasmin generation. Full Text available with Trip Pro

Pharmacodynamic monitoring of factor VIII replacement therapy in hemophilia A: combining thrombin and plasmin generation. Clinical severity of hemophilia A (HA) varies possibly due to interplay of many factors in the hemostatic pathway. Pharmacokinetic monitoring of FVIII replacement therapy in HA patients consists of measuring FVIII activity levels and subsequent dose adjustment. The Nijmegen Hemostasis Assay (NHA) measures thrombin generation (TG) and plasmin generation (PG).Determine (...) minutes after administration and decreased to 15 IU/dL (10-26) at 24 hours. TG was enhanced simultaneously, with thrombin peak height (TPH) increasing from 22nM (15-35) to 222nM (159-255), and thrombin potential (TP) from 404nM/min (undetectable-876) to 1834nM/min (1546-2353). Twenty-four hours after infusion, TG parameters remained high [TPH 73nM (58.5-126.3); TP 1394nM/min (1066-1677)] compared to FVIII activity level. PG showed hyperfibrinolysis in severe HA patients compared to mild patients

2020 Journal of Thrombosis and Haemostasis

30. Coordination of platelet agonist signaling during the hemostatic response in vivo Full Text available with Trip Pro

Coordination of platelet agonist signaling during the hemostatic response in vivo The local microenvironment within an evolving hemostatic plug shapes the distribution of soluble platelet agonists, resulting in a gradient of platelet activation. We previously showed that thrombin activity at a site of vascular injury is spatially restricted, resulting in robust activation of a subpopulation of platelets in the hemostatic plug core. In contrast, adenosine 5'-diphosphate (ADP)/P2Y12 signaling (...) platelet activation in the hemostatic plug core, where thrombin activity is highest. In contrast, epinephrine signaling is dispensable even in the presence of a P2Y12 antagonist. Finally, dual P2Y12 and thrombin inhibition does not substantially inhibit hemostatic plug core formation any more than thrombin inhibition alone, providing further evidence that thrombin is the primary driver of platelet activation in this region. Taken together, these studies show for the first time how thrombin, P2Y12

2017 Blood advances

31. Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface bleeding severity scale. Full Text available with Trip Pro

Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface bleeding severity scale. The safety and efficacy of a hemostatic powder (HP) versus a control agent, absorbable gelatin sponge and thrombin (G + T), were assessed, using a validated, quantitative bleeding severity scale.Subjects were randomized to receive HP (256 subjects) or G + T (132 subjects) for treatment of minimal, mild, or moderate bleeding at 20 investigational sites. The primary efficacy

2019 Journal of cardiac surgery Controlled trial quality: uncertain

32. Evaluation of a lyophilized platelet-derived hemostatic product. Full Text available with Trip Pro

Evaluation of a lyophilized platelet-derived hemostatic product. Current limitations of platelet shelf life to 5 days have led to an increasingly greater demand for hemostatic agents with greater longevity. The objective of this study was to evaluate the function of a lyophilized platelet-derived hemostatic product (thrombosome [TS]) as a potential alternative to fresh platelets.Platelets were collected from whole blood from healthy donors. TSs were reconstituted with water and added to various (...) platelets (p < 0.001 for all agonists). Flow cytometry measures demonstrated significant decreases in glycoprotein Ib expression and increases in phosphatidylserine expression in the TS group (p < 0.01). The calibrated automated thrombogram assay was suggestive (lag time and peak thrombin) that the TSs might have some thrombogenic properties. Measurements of mitochondrial function revealed that TSs had no functional mitochondria.In this study, TSs were shown to have nonfunctional mitochondria. ROTEM

2019 Transfusion

33. Hemostatic characteristics of thawed, pooled cryoprecipitate stored for 35 days at refrigerated and room temperatures. Full Text available with Trip Pro

Hemostatic characteristics of thawed, pooled cryoprecipitate stored for 35 days at refrigerated and room temperatures. Cryoprecipitate's shelf life is limited due to concerns over decreased clotting factor activity and contamination with extended storage. Hemostatic characteristics of thawed cryoprecipitate stored up to 35 days at refrigerated and room temperatures were assessed.Pooled cryoprecipitate was thawed and aliquoted for storage at 1-6°C or 21-24°C. Samples were tested immediately (...) after thawing and at 4 h, 24 h, 72 h, and weekly for 35 days. At each time point fibrinogen, factor VIII (FVIII), and von Willebrand factor (vWF) were assessed. Thrombin generation and rotational thromboelastometry (ROTEM) were also performed. Further, packed red cells, platelet concentrates, frozen plasma, and stored cryoprecipitate were combined (1:1:1:1) to simulate massive transfusion and analyzed by ROTEM. Day 35 samples were cultured for bacterial contamination.Precipitation was observed

2019 Transfusion

34. Optimizing whole blood storage: hemostatic function of 35-day stored product in CPD, CP2D, and CPDA-1 anticoagulants. Full Text available with Trip Pro

Optimizing whole blood storage: hemostatic function of 35-day stored product in CPD, CP2D, and CPDA-1 anticoagulants. Transitioning from whole blood (WB) to components developed from efforts to maximize donor yield. Components are advantageous for specific derangements, but treating hemorrhage with components requires significantly more volume to provide similar effects to WB. Because storage lesion and waste remain problematic, this study examined hemostatic function of refrigerated WB stored (...) for 35 days in anticoagulants citrate-phosphate-dextrose-adenosine (CPDA-1), citrate-phosphate-dextrose (CPD), or citrate-phosphate-double dextrose (CP2D).Refrigerated WB units from healthy donors were sampled over 35 days. Global hemostatic parameters were measured by thromboelastometry, thrombogram, platelet aggregometry, and platelet adhesion to collagen under shear conditions. The effects of transfusion filtration and mixing 35-day stored product with fresh WB were evaluated.Countable platelets

2019 Transfusion

35. Effect of leukoreduction and pathogen reduction on the hemostatic function of whole blood. Full Text available with Trip Pro

(n = 8 for each group): untreated, pathogen reduced (PR+ ), leukoreduced using an in-line filter (LR+ ), or PR+ LR+ . Units were stored without agitation for 21 days between 1° and 6°C, with sampling on days 0 (pre- and post-treatments), 1, 3, 5, 10, 15, and 21 for hemostatic function as assessed by thromboelastometry, thrombin generation, platelet activation factors, and platelet impedance aggregometry.From day 3 (D3) to D15 of storage, platelet count was reduced in PR+ /LR+ units compared to PR (...) - /LR- units. From D10 to D21 of storage, maximum clot firmness (MCF) was reduced in PR+ /LR+ units compared to PR- /LR- units. From D3 to D21 of storage, platelet aggregation was reduced in PR+ /LR+ units compared to PR- /LR- units. Total thrombin generation was similar in all groups from D0 to D21.The combination of LR with a platelet-sparing filter and PR significantly reduces hemostatic function compared to either treatment alone or untreated WB. The clinical consequences of LR and PR of WB

2019 Transfusion

36. Hemostatic properties of cold-stored whole blood leukoreduced using a platelet-sparing versus a non-platelet-sparing filter. (Abstract)

Hemostatic properties of cold-stored whole blood leukoreduced using a platelet-sparing versus a non-platelet-sparing filter. Whole blood (WB) is an appealing alternative to component-based transfusion in patients with significant bleeding. Historically, WB was transfused less than 48 hours after collection and was not leukoreduced (LR). However, LR components are now standard in many hospitals and LR WB is desirable. We investigated the effect of the type of LR filter used, as well as storage (...) duration, on coagulation laboratory testing of WB.Ten units of LR WB-5 units manufactured with a Food and Drug Administration (FDA)-approved platelet (PLT)-sparing filter (WB-PS) and 5 units manufactured with an FDA-approved non-PLT-sparing filter (WB-NPS)-underwent complete blood count, PLT function analyzer (PFA [PFA-100]), thromboelastography (TEG), prothrombin time (PT), partial thromboplastin time (PTT), Factor (F)V activity, chromogenic FVIII, thrombin generation, and microparticle quantification

2019 Transfusion

37. Dynamin 2 is required for GPVI signaling and platelet hemostatic function in mice. Full Text available with Trip Pro

to thrombin. Dnm2Plt-/- platelets lacked fibrinogen in their α-granules, but retained von Willebrand factor. Taken together, the data show that dynamin 2 plays a proximal role in signaling via the collagen receptor GPVI and is required for fibrinogen uptake and normal platelet hemostatic function.Copyright © 2019, Ferrata Storti Foundation. (...) Dynamin 2 is required for GPVI signaling and platelet hemostatic function in mice. Receptor-mediated endocytosis, which contributes to a wide range of cellular functions, including receptor signaling, cell adhesion, and migration, requires endocytic vesicle release by the large GTPase dynamin 2. Here, the role of dynamin 2 was investigated in platelet hemostatic function using both pharmacological and genetic approaches. Dnm2fl/f PF4-Cre (Dnm2Plt-/-) mice specifically lacking dynamin 2 within

2019 Haematologica

38. Increased Clot Formation in the Absence of Increased Thrombin Generation in Patients with Peripheral Arterial Disease: A Case–Control Study Full Text available with Trip Pro

Increased Clot Formation in the Absence of Increased Thrombin Generation in Patients with Peripheral Arterial Disease: A Case–Control Study In peripheral arterial disease (PAD), activation of the hemostatic system may contribute to atherosclerosis progression and atherothrombotic events.This case-control study assesses the overall coagulation status in PAD patients by evaluating coagulation markers in combination with thrombin generation potential, whole blood (WB) clot formation (...) , and fibrinolysis.In blood from 40 PAD patients (n = 20 with cardiovascular event within 1 year after initial diagnosis, n = 20 without) and 40 apparently healthy controls, thrombin generation was determined in WB and platelet-poor plasma. Whole blood rotational thromboelastometry (ROTEM) measurements were triggered with tissue factor with/without tissue plasminogen activator.We observed increased levels of erythrocyte sedimentation rate, leukocytes, eosinophil granulocytes, vWF antigen, fibrinogen, and D-dimer

2017 Frontiers in cardiovascular medicine

39. Thrombin generation and platelet activation in cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy - A prospective cohort study. Full Text available with Trip Pro

Thrombin generation and platelet activation in cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy - A prospective cohort study. Cytoreductive surgery (CRS) with hyperthermic intraperitoneal peroperative chemotherapy (HIPEC), indicated for patients with peritoneal metastases from digestive or gynecological malignancies alike, demonstrates a considerable impact on hemostatic metabolism, both on platelet and on coagulation level. The potential hemostatic interference (...) in CRS and HIPEC is phase dependent. The hypothesis of this prospective cohort study is that the procedure exposed an increased thrombotic risk, resulting in a faster and increased thrombin generation and hyper platelet function.This study explores the combined use of ROTEM (rotational thromboelastometry), PACT (platelet activation test) and CAT (thrombin generation test) assays during CRS and HIPEC with a follow-up of 7 days postoperative in 27 patients with confirmed histological diagnosis

2018 PLoS ONE

40. Thrombin generating potential, plasma clot formation and clot lysis are impaired in patients with bleeding of unknown cause. Full Text available with Trip Pro

clot lysis time (CLT) than in healthy controls. Comparing patients with FVIII activity ≤ 50% to those with BUC, parameters of thrombin generation and clot formation and lysis were either stronger or comparably impaired. Bleeding severity did not correlate with parameters of thrombin generation, clot formation, or clot lysis.Patients with BUC have an impaired hemostatic capacity reflected by a lower thrombin-generation potential, a lower clot formation rate, increased clot turbidity, and shorter (...) Thrombin generating potential, plasma clot formation and clot lysis are impaired in patients with bleeding of unknown cause. In a large proportion of patients with a mild to moderate bleeding tendency no diagnosis can be established (bleeding of unknown cause, BUC).To investigate possible dysfunctions in thrombin generation and plasma clot formation and lysis in patients with BUC from the Vienna Bleeding Biobank (VIBB).Thrombin generation and plasma clot properties of 382 BUC patients were

2019 Journal of Thrombosis and Haemostasis

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