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Thrombin Hemostatic

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21. Hemostatic Matrix (FloSeal) as Treatment for Urethral Crush Injury After Failure of Traditional Hemostatic Technique. (PubMed)

Hemostatic Matrix (FloSeal) as Treatment for Urethral Crush Injury After Failure of Traditional Hemostatic Technique. We report a case of traumatic arterial hemorrhage from the posterior urethral artery, refractory to traditional hemostatic technique, and successfully managed with intraurethral thrombin hemostatic matrix (FloSeal [Baxter Healthcare Corporation, Deerfield, Illinois, US]). We believe that this demonstrates a safe, effective therapy for urethral hemorrhage that may be accomplished

2016 Annals of Emergency Medicine

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

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

23. Evaluation of a lyophilized platelet-derived hemostatic product. (PubMed)

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

24. Hemostatic characteristics of thawed, pooled cryoprecipitate stored for 35 days at refrigerated and room temperatures. (PubMed)

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

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2019 Transfusion

25. Optimizing whole blood storage: hemostatic function of 35-day stored product in CPD, CP2D, and CPDA-1 anticoagulants. (PubMed)

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

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2019 Transfusion

26. Effect of leukoreduction and pathogen reduction on the hemostatic function of whole blood. (PubMed)

(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

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2019 Transfusion

27. Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface bleeding severity scale. (PubMed)

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

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2019 Journal of cardiac surgery Controlled trial quality: uncertain

28. Dynamin 2 is required for GPVI signaling and platelet hemostatic function in mice. (PubMed)

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

29. Increased Clot Formation in the Absence of Increased Thrombin Generation in Patients with Peripheral Arterial Disease: A Case–Control Study (PubMed)

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

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2017 Frontiers in cardiovascular medicine

30. Thrombin generation and platelet activation in cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy - A prospective cohort study. (PubMed)

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

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2018 PLoS ONE

31. Fatal dysfunction and disintegration of thrombin-stimulated platelets. (PubMed)

Fatal dysfunction and disintegration of thrombin-stimulated platelets. Platelets play a key role in formation of hemostatic clots and obstructive thrombi as well as in other biological processes. In response to physiological stimulants, including thrombin, platelets change their morphology, express adhesive molecules, undergo aggregation, and secrete bioactive substances, but their subsequent fate is largely unknown. Here we examine late-stage structural, metabolic, and functional consequences (...) of thrombin-induced platelet activation. Using a combination of confocal microscopy, scanning and transmission electron microscopy, flow cytometry, biochemical and biomechanical measurements, we show that thrombin-induced activation is followed by time-dependent platelet dysfunction and disintegration. After ~30 minutes of incubation with thrombin, unlike with collagen or ADP, human platelets underwent disintegration into cellular fragments containing organelles, such as mitochondria, glycogen granules

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2019 Haematologica

32. Thrombin generating potential, plasma clot formation and clot lysis are impaired in patients with bleeding of unknown cause. (PubMed)

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

33. The central role of thrombin in bleeding disorders. (PubMed)

The central role of thrombin in bleeding disorders. Maintaining normal hemostasis relies on a regulated system of procoagulant and anticoagulant pathways, and disruption of these processes leads to the loss of hemostatic control, with the potential for excessive bleeding or thrombosis. Evaluation of bleeding disorders has conventionally been achieved by laboratory assays that measure the activity of individual coagulation factors. While such assays have proven effective for detecting (...) abnormalities of the coagulation system and aiding diagnosis, inherent limitations prevent them from capturing a complete picture of hemostatic function. An improved understanding of thrombin activity and its central role in hemostasis and bleeding disorders has led to the clinical development of global assays that are more physiologically relevant than traditional assays; furthermore, these global assays are able to monitor responses to therapy. In this review, we provide an overview of the role

2019 Blood reviews

34. Elevated thrombin generation in patients with congenital disorder of glycosylation and combined coagulation factor deficiencies. (PubMed)

Elevated thrombin generation in patients with congenital disorder of glycosylation and combined coagulation factor deficiencies. Congenital disorders of glycosylation are rare inherited diseases affecting many different proteins. The lack of glycosylation notably affects the hemostatic system and leads to deficiencies of both procoagulant and anticoagulant factors.To assess the hemostatic balance in patients with multiple coagulation disorders by using a thrombin generation assay.We performed (...) conventional coagulation assays and a thrombin generation assay on samples from patients with congenital disorder of glycosylation. The thrombin generation assay was performed before and after activation of the protein C system by the addition of soluble thrombomodulin.A total of 35 patients were included: 71% and 57% had low antithrombin and factor XI levels, respectively. Protein C and protein S levels were abnormally low in 29% and 26% of the patients, respectively, whereas only 11% displayed low factor

2019 Journal of Thrombosis and Haemostasis

35. Prospective, Randomized, Phase II, Non-Inferiority Study to Evaluate the Safety and Efficacy of Topical Thrombin (Human) Grifols as Adjunct to Hemostasis During Vascular, Hepatic, Soft Tissue, and Spinal Open Surgery. (PubMed)

Prospective, Randomized, Phase II, Non-Inferiority Study to Evaluate the Safety and Efficacy of Topical Thrombin (Human) Grifols as Adjunct to Hemostasis During Vascular, Hepatic, Soft Tissue, and Spinal Open Surgery. Thrombin-based formulations have been used for topical hemostasis in surgery for decades. However, the number of randomized clinical trials comparing bovine vs human thrombin is limited.A randomized, double-blind, non-inferiority phase II study evaluated the hemostatic efficacy (...) in vascular, hepatic, soft tissue, and spinal operations ranged from 75.0% to 82.5% for TTH-Grifols and from 54.5% to 91.7% for BT-JMI. No significant differences in adverse events were observed between treatment groups. Antibodies to bovine factor V antigen were detected in 2 patients exposed to BT-JMI and in none exposed to TTH-Grifols.The TTH-Grifols was safe and well tolerated as a local hemostatic agent and was non-inferior to BT-JMI. No antibodies to thrombin developed in TTH-Grifols-treated

2019 Journal of the American College of Surgeons Controlled trial quality: predicted high

36. In vitro analysis of growth patterns of invasive fungal species on commonly used endonasal hemostatic agents. (PubMed)

In vitro analysis of growth patterns of invasive fungal species on commonly used endonasal hemostatic agents. Previous studies have not examined the potential role of endonasal hemostatic agents in facilitating growth of fungal species. We aim to determine the possibility of these to serve as a nutrient source for fungal growth.Cultures of Aspergillus, Fusarium, and Mucor were harvested and placed in solution in sterile saline at standardized high and low concentrations. Thrombin gelatin matrix (...) Fusarium growth was noted on all packing material by day three. Carboxyl methylcellulose also supported growth of high-concentration Mucor appreciated on day five. The potato starch derivative supported fulminant growth of all fungal species.Endonasal hemostatic agents may be nutrient sources that facilitate growth of fungal species. This may be a consideration in a surgeon's decision to use a hemostatic agent. Prompt initial post-operative debridement may be warranted in select patients. Our findings

2018 American Journal of Otolaryngology

37. Hemostatic profile under fluid resuscitation during rivaroxaban anticoagulation: an in vitro survey. (PubMed)

, prothrombin complex concentrate (PCC), and combinations thereof on the hemostatic profile of rivaroxaban-anticoagulated whole blood and plasma. We used rivaroxaban-spiked whole blood and plasma from healthy donors, as well as plasma from patients on rivaroxaban, and mimicked a resuscitation approach in a 50% plasma dilution setting. Thromboelastography, thrombin generation, and fibrin generation clot lysis test were assessed using tissue factor to initiate coagulation and tissue plasminogen activator (...) Hemostatic profile under fluid resuscitation during rivaroxaban anticoagulation: an in vitro survey. Uncontrollable bleeding is the leading cause of death in traumatically injured patients. The extent to which direct factor Xa inhibitors interfere with the applied resuscitation measures is presently unknown.In this study, we investigated the effect of the resuscitation fluids saline, albumin, fresh frozen plasma (FFP) and solvent/detergent (S/D)-treated plasma, fibrinogen concentrate

2018 Transfusion

38. Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations

sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures. Active Comparator: FLOSEAL (Hemostatic Device) Bleeding sites will be treated with FLOSEAL per its approved Indications for Use Device: FLOSEAL The FLOSEAL Matrix consists of a bovine-derived Gelatin Matrix (...) component, a human-derived Thrombin component, applicator tips, and several mixing accessories. FLOSEAL is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. Outcome Measures Go to Primary Outcome Measures : 3 minute hemostasis - hemostatic success (yes/no) at 3 minutes [ Time Frame: Intraoperative ] The primary endpoint of this study is the superiority of HEMOBLAST™ relative

2018 Clinical Trials

39. Pleiotropic effects of the hemostatic system. (PubMed)

Pleiotropic effects of the hemostatic system. Atherothrombosis is characterized by the inflammatory process of atherosclerosis combined with a hypercoagulable state leading to superimposed thrombus formation. In atherosclerotic plaques, cell signaling can occur via protease-activated receptors (PARs), four of which have been identified so far (PAR1-PAR4). Proteases that are able to activate PARs can be produced systemically, but also at the sites of lesions, and they include thrombin

2018 Journal of Thrombosis and Haemostasis

40. Platelet packing density is an independent regulator of the hemostatic response to injury. (PubMed)

Platelet packing density is an independent regulator of the hemostatic response to injury. Essentials Platelet packing density in a hemostatic plug limits molecular movement to diffusion. A diffusion-dependent steep thrombin gradient forms radiating outwards from the injury site. Clot retraction affects the steepness of the gradient by increasing platelet packing density. Together, these effects promote hemostatic plug core formation and inhibit unnecessary growth.Background Hemostasis studies (...) performed in vivo have shown that hemostatic plugs formed after penetrating injuries are characterized by a core of highly activated, densely packed platelets near the injury site, covered by a shell of less activated and loosely packed platelets. Thrombin production occurs near the injury site, further activating platelets and starting the process of platelet mass retraction. Tightening of interplatelet gaps may then prevent the escape and exchange of solutes. Objectives To reconstruct the hemostatic

2018 Journal of Thrombosis and Haemostasis

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