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Thrombin Hemostatic

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302. Rixubis - nonacog gamma

factor and it is synthesised in the liver. Factor IX is activated by factor XIa in the intrinsic coagulation pathway and by factor VII/tissue factor complex in the extrinsic pathway. Activated factor IX, in combination with activated factor VIII, activates factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot is formed. The Applicant applied for the following indication which was finally approved: Rixubis is indicated (...) such as the thrombin generation assay, as well as the efficiency of activation by FXIa and FVIIa in the presence of tissue factor and the capacity to bind to phospholipid vesicles sufficiently support primary PD of nonacog gamma as discussed under Quality aspects Secondary pharmacodynamic studies Secondary pharmacodynamic studies have not been submitted. Safety pharmacology programme Three in vivo safety pharmacology studies were conducted in rabbits and monkeys to assess the thrombogenic potential of nonacog

2014 European Medicines Agency - EPARs

303. Hemostasis stimulates lymphangiogenesis through release and activation of VEGFC. (Abstract)

Hemostasis stimulates lymphangiogenesis through release and activation of VEGFC. Hemostasis associated with tissue injury is followed by wound healing, a complex process by which damaged cellular material is removed and tissue repaired. Angiogenic responses are a central aspect of wound healing, including the growth of new lymphatic vessels by which immune cells, protein and fluid are transported out of the wound area. The concept that hemostatic responses might be linked to wound healing (...) responses is an old one, but demonstrating such a link in vivo and defining specific molecular mechanisms by which the two processes are connected has been difficult. In the present study we demonstrate that the lymphangiogenic factors VEGFC and VEGFD are cleaved by thrombin and plasmin, serine proteases generated during hemostasis and wound healing. Using a new tail wounding assay to test the relationship between clot formation and lymphangiogenesis in mice, we find that platelets accelerate lymphatic

2019 Blood

304. All-Trans Retinoic Acid Impairs Platelet Function and Thrombus Formation and Inhibits Protein Kinase CßI/δ Phosphorylation. (Abstract)

All-Trans Retinoic Acid Impairs Platelet Function and Thrombus Formation and Inhibits Protein Kinase CßI/δ Phosphorylation. All-trans retinoic acid (ATRA) is widely used for induction of complete remission in patients with acute promyelocytic leukemia (APL). ATRA also regulates protein kinase C (PKC) activity. Therapeutic use of ATRA reportedly interferes with hemostatic function in APL patients, including effects on coagulation or other vascular cells, although effects of ATRA on platelets (...) and adenosine triphosphate release induced by collagen (5 μg/mL) or thrombin (0.05 U/mL) in a dose-dependent manner without affecting P-selectin expression or surface levels of glycoprotein (GP) Ibα, GPVI, or αIIbβ3. ATRA-treated platelets demonstrated reduced spreading on immobilized fibrinogen or collagen and reduced thrombin-induced clot retraction together with reduced phosphorylation of Syk and PLCγ2. In addition, ATRA-treated mice displayed significantly impaired hemostasis and arterial thrombus

2019 Thrombosis and haemostasis

305. Platelet-derived extracellular vesicles released after trauma promote hemostasis and contribute to DVT in mice. Full Text available with Trip Pro

and function of PEVs generated following traumatic injury.PEV content and quantity in circulation following trauma in humans and mice was measured using flow cytometry, size exclusion chromatography, and nanoparticle tracking analysis. PEVs were isolated from circulation and the effects on thrombin generation, bleeding time, hemorrhage control, and thrombus formation were determined. Finally, the effect of hydroxychloroquine (HCQ) on PEV release and thrombosis were examined.Human and murine trauma results (...) in a significant release of PEVs into circulation compared with healthy controls. These PEVs result in abundant thrombin generation, increased platelet aggregation, decreased bleeding times, and decreased hemorrhage in uncontrolled bleeding. Conversely, PEVs contributed to enhanced venous thrombus formation and were recruited to the developing thrombus site. Interestingly, HCQ treatment resulted in decreased platelet aggregation, decreased PEV release, and reduced deep vein thrombosis burden in mice.These data

2019 Journal of Thrombosis and Haemostasis

306. Intrinsic differences between FVIIIa mimetic bispecific antibodies and FVIII prevent assignment of FVIII-equivalence. Full Text available with Trip Pro

capacity to assess hemostatic potential of bsAb therapies.Activated factor VIII (FVIIIa) mimetic bsAbs aim to enable prophylactic treatment of hemophilia A patients with and without inhibitors. With different mechanisms of action, benchmarking their activity against FVIII to determine efficacious yet safe dosage is difficult.To compare the activities of sequence identical emicizumab (SI-Emi) and another bsAb, BS-027125, to recombinant FVIII (rFVIII) using clinical and nonclinical assays and to evaluate (...) our ability to assign a FVIII-equivalent value to bsAbs and implications thereof.Activities of SI-Emi, BS-027125, and rFVIII were measured by one-stage clotting assay, chromogenic factor Xa generation assay, and thrombin generation assay. We also assessed the activity of anti-FIXa and anti-FX bivalent homodimers of each bsAb and probed the effect of different reagents in thrombin generation assay (TGA).The FVIII-like activity of SI-Emi and BS-027125 ranged greatly across each assay, varying both

2019 Journal of Thrombosis and Haemostasis

307. Long-Term Dabigatran Treatment Delays Alzheimer's Disease Pathogenesis in the TgCRND8 Mouse Model. Full Text available with Trip Pro

Long-Term Dabigatran Treatment Delays Alzheimer's Disease Pathogenesis in the TgCRND8 Mouse Model. Alzheimer's disease (AD) is a multifactorial neurodegenerative disorder with important vascular and hemostatic alterations that should be taken into account during diagnosis and treatment.This study evaluates whether anticoagulation with dabigatran, a clinically approved oral direct thrombin inhibitor with a low risk of intracerebral hemorrhage, ameliorates AD pathogenesis in a transgenic mouse (...) thrombin and the formation of occlusive thrombi in AD; preserved cognition, cerebral perfusion, and BBB function; and ameliorated neuroinflammation and amyloid deposition in AD mice. Our results open a field for future investigation on whether the use of direct oral anticoagulants might be of therapeutic value in AD.Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.

2019 Journal of the American College of Cardiology

308. Vascular PAR4 upregulation, increased platelet aggregation, and coronary lipid deposits induced by long-term dabigatran administration-results from a diabetes animal model. (Abstract)

atherosclerotic and atherothrombotic risk. SUMMARY: Background Besides its role in the coagulation cascade, thrombin contributes to platelet aggregation and to a plethora of non-hemostatic functions. Objectives To assess the impact of long-term thrombin inhibition with dabigatran etexilate (DE) on platelet aggregation and on extrahemostatic thrombin-related functions in diabetic and control rats. Methods Markers of inflammation, endothelial dysfunction, oxidative stress, angiogenesis and cell adhesion (...) Vascular PAR4 upregulation, increased platelet aggregation, and coronary lipid deposits induced by long-term dabigatran administration-results from a diabetes animal model. Essentials The impact of long-term thrombin inhibition outside the coagulation cascade is far from clear. We aimed to assess the impact of dabigatran etexilate (DE) in diabetic and control rats. In diabetic rats, DE increased platelet aggregation and lead to coronary lipid deposits. Long-term thrombin inhibition may increase

2019 Journal of Thrombosis and Haemostasis

309. Targeting of Antithrombin in Hemophilia A or B with RNAi Therapy. Full Text available with Trip Pro

Targeting of Antithrombin in Hemophilia A or B with RNAi Therapy. Current hemophilia treatment involves frequent intravenous infusions of clotting factors, which is associated with variable hemostatic protection, a high treatment burden, and a risk of the development of inhibitory alloantibodies. Fitusiran, an investigational RNA interference (RNAi) therapy that targets antithrombin (encoded by SERPINC1), is in development to address these and other limitations.In this phase 1 dose-escalation (...) . A reduction in the antithrombin level of more than 75% from baseline resulted in median peak thrombin values at the lower end of the range observed in healthy participants.Once-monthly subcutaneous administration of fitusiran resulted in dose-dependent lowering of the antithrombin level and increased thrombin generation in participants with hemophilia A or B who did not have inhibitory alloantibodies. (Funded by Alnylam Pharmaceuticals; ClinicalTrials.gov number, NCT02035605 .).

2017 NEJM Controlled trial quality: uncertain

310. Thromboinflammation: Challenges of Therapeutically Targeting Coagulation and other Host Defence Mechanisms. Full Text available with Trip Pro

in the microvasculature. α-Thrombin plays a critical role in coordinating thrombotic and inflammatory responses and has long been considered an attractive therapeutic target to reduce thromboinflammatory complications. This review focuses on the role of basic aspects of coagulation and α-thrombin in promoting thromboinflammatory responses and discusses insights gained from clinical trials on the effects of various inhibitors of coagulation on thromboinflammatory disorders. Studies in sepsis patients have been (...) prothrombotic and proinflammatory functions independent of their hemostatic effects.© 2019 by The American Society of Hematology.

2019 Blood

311. Voncento - human coagulation factor VIII / human von willebrand factor

. VWF and FVIII are two distinct glycoproteins that circulate in plasma in the form of a non-covalently bound complex. Both factors are essential for normal haemostasis in humans. Deficiencies in FVIII or VWF lead to two distinct hereditary coagulation disorders: haemophilia A and von Willebrand disease (VWD). Voncento belongs to the pharmacological class of hemostatic agents. The product is administered by intravenous infusion to raise FVIII and VWF levels in patients with corresponding

2013 European Medicines Agency - EPARs

312. Hemostatic proteins and their association with hematoma growth in patients with acute intracerebral hemorrhage. Full Text available with Trip Pro

Hemostatic proteins and their association with hematoma growth in patients with acute intracerebral hemorrhage. We tested the hypothesis that proteins of hemostasia could be associated with hematoma growth (HG) in patients with acute intracerebral hemorrhage.We prospectively studied patients with spontaneous supratentorial intracerebral hemorrhage within the first 6 hours after the onset of symptoms. HG was defined as an increase > 33% in the volume of hematoma on CT obtained 24 to 72 hours (...) after the onset of symptoms in comparison with the CT obtained at admission. We collected admission and follow-up blood samples. We measured fibrinogen, factor XIII, thrombin activatable fibrinolysis inhibitor, plasminogen activator inhibitor, plasminogen, α₂-antiplasmin, tissue plasminogen activator, d-dimer, thrombomodulin, thrombin-antithrombin complex, and plasmin-antiplasmin complex.We included 90 patients with a mean age of 71 ± 10.8 years; 61% were men. HG was observed in 35 (39

2010 Stroke

313. [Comparison of hemostatic markers under different techniques for anesthesia-analgesia in total hip or knee replacement]. (Abstract)

[Comparison of hemostatic markers under different techniques for anesthesia-analgesia in total hip or knee replacement]. Surgery promotes a state of hypercoagulability, predisposing to the possibility of postoperative thromboembolic complications. Our aim was to determine whether certain combinations of techniques (neuraxial, intravenous or both) for anesthesia and analgesia might be associated with attenuation of the prethrombotic state following total hip or knee replacement.Prospective (...) of prothrombin activation fragments 1 and 2, thrombin-antithrombin III complex, and D-dimer.No statistically significant between-group differences were found in patient demographic, clinical, surgical or postoperative data. No symptomatic thromboembolic complications or deaths were recorded in the 30 days after surgery. Statistically significant differences were found in laboratory results for samples taken 36 hours after surgery. Patients who received spinal-epidural anesthesia and analgesia had lower

2010 Revista española de anestesiología y reanimación Controlled trial quality: uncertain

314. An open-label, comparative study of the effects of a dose-reduced oral contraceptive containing 0.02 mg ethinylestradiol/2 mg chlormadinone acetate on hemostatic parameters and lipid and carbohydrate metabolism variables. (Abstract)

An open-label, comparative study of the effects of a dose-reduced oral contraceptive containing 0.02 mg ethinylestradiol/2 mg chlormadinone acetate on hemostatic parameters and lipid and carbohydrate metabolism variables. The study was conducted to compare the effects of 0.02 mg ethinylestradiol (EE)/2 mg chlormadinone acetate (CMA), given for 24 days each cycle, with those of 0.02 mg EE/0.15 mg desogestrel (DSG) and 0.03 mg EE/0.15 mg levonorgestrel (LNG), given for 21 days each cycle (...) , on hemostatic, lipid, and carbohydrate metabolism parameters in healthy subjects, over six medication cycles.A randomized, multicentre, open-label, Phase II trial measured markers of hemostasis, and of lipid and carbohydrate metabolism in 165 subjects randomly assigned to treatment with one of three combined oral contraceptives (COCs).EE/CMA and EE/DSG had a similar effect on hemostatic parameters, the EE/LNG group showed comparatively smaller increases in the activity of factor VII [8.1% vs. 36.6% (EE/CMA

2010 Contraception Controlled trial quality: uncertain

315. A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women

A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have (...) reached the maximum number of saved studies (100). Please remove one or more studies before adding more. A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT01252186

2010 Clinical Trials

316. Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose Design 9 System

Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose Design 9 System Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose Design 9 System - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies (...) before adding more. Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose Design 9 System The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT01121510 Recruitment Status : Withdrawn (medical center difficulties in recruiting patients for the study in a timely fashion) First Posted : May

2010 Clinical Trials

317. CD14 inhibition efficiently attenuates early inflammatory and hemostatic responses in Escherichia coli sepsis in pigs Full Text available with Trip Pro

preserved the leukocyte count and significantly reduced granulocyte enzyme matrix metalloproteinase-9 release and expression of the granulocyte membrane activation molecule wCD11R3 (pig CD11b). The hemostatic markers thrombin-antithrombin III complexes and plasminogen activator inhibitor-1 were significantly attenuated. Anti-CD14 did not affect LPS or E. coli DNA levels. This study documents that CD14 inhibition efficiently attenuates the proinflammatory cytokine response and granulocyte activation (...) CD14 inhibition efficiently attenuates early inflammatory and hemostatic responses in Escherichia coli sepsis in pigs Sepsis is a severe infection-induced systemic inflammatory syndrome. Inhibition of downstream inflammatory mediators of sepsis, e.g., TNF-alpha, has failed in clinical trials. The aim of this study was to investigate the effects of inhibiting CD14, a key upstream innate immunity molecule, on the early inflammatory and hemostatic responses in a pig model of gram-negative sepsis

2010 The FASEB Journal

318. Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel)

. Device: Vitagel Vitagel (by Stryker) is a topical surgical hemostat spray that results in coagulation. The components are as follows: autogenous blood is drawn and centrifuged to produce a sample of platelets and growth factors; this is combined with a bovine thrombin and collagen solution. When the two are applied together, it produces the hemostatic effect. Procedure: Standard of care Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels (...) Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel) Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel) - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies

2010 Clinical Trials

319. Comparison of acute and convalescent biomarkers of inflammation in patients with acute pulmonary embolism treated with systemic fibrinolysis vs. placebo. (Abstract)

), myeloperoxidase (MPO)] and hemostatic [plasminogen activator inhibitor-1 (PAI-1), fibrinogen, thrombin-activatable fibrinolysis inhibitor and D-dimer] biomarkers were quantified. The median values of the biomarkers of inflammation (IL-6, CRP, MPO) were all significantly decreased at 3-month follow-up, ranging from a 60 to 91% reduction over this time period. Concentrations of PAI-1 and fibrinogen did not change significantly. D-dimer concentration at 3-month follow-up was lower in patients treated (...) Comparison of acute and convalescent biomarkers of inflammation in patients with acute pulmonary embolism treated with systemic fibrinolysis vs. placebo. : Previous studies have associated biomarkers indicative of acute inflammation with pulmonary embolism, which may amplify coagulation, inhibit fibrinolysis and increase risk of venous thromboembolism (VTE) recurrence. The aim of this study was to measure inflammatory and hemostatic biomarkers in acute submassive pulmonary embolism at diagnosis

2018 Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis Controlled trial quality: uncertain

320. Better platelet function, less fibrinolysis and less hemolysis in re-transfused residual pump blood with the Ringer's chase technique - a randomized pilot study. (Abstract)

Better platelet function, less fibrinolysis and less hemolysis in re-transfused residual pump blood with the Ringer's chase technique - a randomized pilot study. Residual pump blood from the cardiopulmonary bypass (CPB) circuit is often collected into an infusion bag (IB) and re-transfused. An alternative is to chase the residual blood into the circulation through the arterial cannula with Ringer's acetate. Our aim was to assess possible differences in hemostatic blood quality between these two (...) were comparable with the two methods, as were soluble platelet activation markers P-selectin and soluble glycoprotein VI (GPVI). Platelet aggregation (U) in the IB blood was significantly lower compared to the RC blood, with the agonists adenosine diphosphate (ADP) 24 (10-32) vs 46 (33-65), p<0.01, thrombin receptor activating peptide (TRAP) 50 (29-73) vs 69 (51-92), p=0.04 and collagen 24 (17-28) vs 34 (26-59), p<0.01. The IB blood had higher amounts of free hemoglobin (mg/L) (1086 (891-1717) vs

2018 Perfusion Controlled trial quality: uncertain

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