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Thrombin Hemostatic

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1201. Serological analysis of patients treated with a new surgical hemostat containing bovine proteins and autologous plasma. (Abstract)

Serological analysis of patients treated with a new surgical hemostat containing bovine proteins and autologous plasma. A randomized, controlled clinical study of the management of diffuse bleeding with CoStasis surgical hemostat, a new hemostat containing bovine thrombin and collagen with the patient's own plasma, included patients undergoing cardiac, hepatic, iliac, and general surgery. Sera from 92 patients treated with CoStasis and 84 control patients were collected preoperatively (...) study, CoStasis was shown to be a safe and effective hemostatic product containing bovine thrombin and bovine collagen and no pooled human blood products.Copyright 2001 John Wiley & Sons, Inc.

2001 Journal of biomedical materials research Controlled trial quality: uncertain

1202. Evaluation of a novel hemostatic device in an ovine parenchymal organ bleeding model of normal and impaired hemostasis. (Abstract)

Evaluation of a novel hemostatic device in an ovine parenchymal organ bleeding model of normal and impaired hemostasis. Bleeding is a problem encountered by many surgeons, often complicated by the presence of coagulopathy or anticoagulant. The hemostatic effectiveness of CoStasis Surgical Hemostat (with bovine collagen, bovine thrombin, and autologous plasma) was evaluated and compared to a collagen sponge and to two investigational fibrin-sealant preparations under conditions of normal (...) (investigational fibrin sealant 2) had comparable mean times to hemostasis, and CoStasis-treated sites exhibited lowered average blood loss compared to investigational fibrin-sealant-2 treated sites. CoStasis-treated sites demonstrated higher levels of tissue repair (lower inflammation, more extensive tissue repair, and less residual implant) compared to fibrin-sealant- or collagen-sponge-treated sites in Phases I and II. These findings demonstrate that CoStasis is a highly effective hemostatic agent

2002 Journal of biomedical materials research

1203. Markers of hemostatic system activation during treatment of deep vein thrombosis with subcutaneous unfractionated or low-molecular weight heparin. (Abstract)

Markers of hemostatic system activation during treatment of deep vein thrombosis with subcutaneous unfractionated or low-molecular weight heparin. Prothrombin fragments (F1+2), thrombin-antithrombin complexes (TAT) and D-dimers, markers of hemostatic system activation, were measured in 59 consecutive patients with deep vein thrombosis (DVT). Patients were randomly treated either with subcutaneous unfractionated heparin (UH) administered in two to three subcutaneous doses adjusted to activated (...) and TAT significantly decreased to reference values in almost all patients (in 64/66 determinations of both F1+2 and TAT) and remained low on the seventh day of treatment. Compared to pretreatment values, a nonsignificant decrease of D-dimer was noted in both groups, but all values remained above the cut-off value. When markers of hemostatic system activation in the UH and LMWH groups were compared, no significant differences were observed. It was concluded that subcutaneous UH in an APTT-adjusted

2002 Thrombosis research Controlled trial quality: uncertain

1204. Hemostatic activation and inflammatory response during cardiopulmonary bypass: impact of heparin management. (Abstract)

Hemostatic activation and inflammatory response during cardiopulmonary bypass: impact of heparin management. Cardiac surgery involving cardiopulmonary bypass (CPB) leads to fulminant activation of the hemostatic-inflammatory system. The authors hypothesized that heparin concentration-based anticoagulation management compared with activated clotting time-based heparin management during CPB leads to more effective attenuation of hemostatic activation and inflammatory response. In a randomized (...) prospective study, the authors compared the influence of anticoagulation with a heparin concentration-based system (Hepcon HMS; Medtronic, Minneapolis, MN) to that of activated clotting time-based management on the activation of the hemostatic-inflammatory system during CPB.Two hundred elective patients (100 in each group) undergoing standard cardiac surgery in normothermia were enrolled. No antifibrinolytic agents or aprotinin and no heparin-coated CPB systems were used. Samples were collected after

2002 Anesthesiology Controlled trial quality: uncertain

1205. Hemostatic effect of Vivostat patient-derived fibrin sealant on split-thickness skin graft donor sites. (Abstract)

Hemostatic effect of Vivostat patient-derived fibrin sealant on split-thickness skin graft donor sites. Topical hemostatic agents are used frequently to control bleeding of skin graft donor sites. In this study, the hemostatic properties of Vivostat (Vivolution A/S, Birkerød, Denmark) patient-derived fibrin sealant were compared with a control group of spray thrombin solution, which is considered an industry standard for topical hemostasis. Treatments were applied simultaneously to two randomly (...) (medians: Vivostat, 31 seconds; thrombin, 58 seconds; p=0.0012). No abnormalities in wound healing were reported for either treatment site 1 week after the operation. Vivostat (Vivolution A/S) sealant is a more rapidly effective topical hemostatic agent than thrombin on split-thickness skin graft donor sites.

2003 Annals of plastic surgery Controlled trial quality: uncertain

1206. Management of heparin resistance during cardiopulmonary bypass: the effect of five different anticoagulation strategies on hemostatic activation. (Abstract)

Management of heparin resistance during cardiopulmonary bypass: the effect of five different anticoagulation strategies on hemostatic activation. Attenuation of hemostatic activation is a central goal during CPB. However, this poses a problem in patients insensitive to heparin. The present investigation was performed to assess different strategies of managing patients with heparin resistance during CPB.A randomized, prospective clinical investigation.A major European heart center.Five groups (...) with 20 patients each were investigated.The groups were handled as follows: (1). maintenance of a target ACT, (2). maintenance of the target unfractionated heparin (UFH) level and supplementation of a UFH level-based strategy with (3). AT III, (4). the direct thrombin inhibitor r-hirudin, or (5). the short-acting platelet glycoprotein (GP) IIb/IIIa antagonist tirofiban. Platelet count and generation of contact factor XIIa, thrombin, and soluble fibrin were assessed. Samples were obtained before CPB

2003 Journal of cardiothoracic and vascular anesthesia Controlled trial quality: uncertain

1207. The effects of seven monophasic oral contraceptive regimens on hemostatic variables: conclusions from a large randomized multicenter study. (Abstract)

The effects of seven monophasic oral contraceptive regimens on hemostatic variables: conclusions from a large randomized multicenter study. We investigated the effects of ethinylestradiol dose (50, 30 and 20 microg) and progestogen type [desogestrel (DSG), gestodene (GSD), levonorgestrel (LNG) and norgestimate (NGM)] in oral contraceptives on 24 hemostatic variables. In a multicenter, randomized, comparative study, 707 healthy, nonsmoking, nulliparous women were treated for six cycles with one (...) of the seven monophasic oral contraceptives tested. Significantly greater increases in prothrombin fragment 1+2 and factor VII (activity and antigen), were found in the DSG, NGM and GSD groups compared to the LNG group. Similarly, significantly lower levels of protein S (free and total) and increased APC-sr (endogenous thrombin potential based) were found in the same groups compared with the LNG group. In addition, the estradiol dose (50 vs. 30 microg) significantly influenced these parameters. All changes

2003 Contraception Controlled trial quality: uncertain

1208. Comparison of general and spinal anesthesia and their influence on hemostatic markers in patients undergoing total hip arthroplasty. (Abstract)

Comparison of general and spinal anesthesia and their influence on hemostatic markers in patients undergoing total hip arthroplasty. To evaluate the profile of molecular hemostatic markers in patients receiving either spinal or balanced general anesthesia for total hip arthroplasty.Open, randomized, observational study.Orthopedic unit and central laboratory of a university hospital.26 consenting ASA physical status II and III inpatients undergoing total hip arthroplasty with general balanced (...) centrifuged within 1 hour of collection at 2,300 g for 15 minutes at 4 degrees C. Hemoglobin, hematocrit, platelets, fibrinogen, prothrombin time, thrombin time, activated partial thromboplastin time, antithrombin, and protein C were measured immediately on arrival at the laboratory. Specimens were then aliquoted and stored at -70 degrees C. Within 2 weeks, samples were thawed and prepared for the following assays: thrombin-antithrombin complexes (TAT complexes), D-dimers, plasminogen activator inhibitor

2003 Journal of clinical anesthesia Controlled trial quality: uncertain

1209. Effects of low-dose oral and transdermal estrogen replacement therapy on hemostatic factors in healthy postmenopausal women: a randomized placebo-controlled study. (Abstract)

Effects of low-dose oral and transdermal estrogen replacement therapy on hemostatic factors in healthy postmenopausal women: a randomized placebo-controlled study. This study was undertaken to investigate the effect of transdermal and oral estrogen replacement therapy in healthy postmenopausal women on markers of coagulation and fibrinolysis associated with coronary artery disease.In a randomized, placebo-controlled, double-blind study, healthy hysterectomized postmenopausal women received (...) daily either placebo (n=49), transdermal 17beta-estradiol (E(2)) 50 microg (tE(2) group, n=33), oral E(2) 1 mg (oE(2) group, n=37), or oral E(2) 1 mg combined with gestodene 25 microg (oE(2)+G group, n=33) for thirteen 28-day treatment cycles. Hemostatic variables were measured in blood samples collected at baseline and in cycles 4 and 13.No significant changes versus baseline and placebo were found in the tE(2) group, except for plasminogen activator inhibitor type-1 (PAI-1) in cycle 13 (-32.4%, P

2003 American journal of obstetrics and gynecology Controlled trial quality: uncertain

1210. Heparin-level-based anticoagulation management during cardiopulmonary bypass: a pilot investigation on the effects of a half-dose aprotinin protocol on postoperative blood loss and hemostatic activation and inflammatory response. (Abstract)

during CPB. Postoperative blood loss was determined after 12 h. Heparin and antithrombin activity were evaluated by an anti-Xa assay and measurement of antithrombin III activity. Hemostatic activation was evaluated by adenosine diphosphate-stimulated platelet aggregometry and by measurements of the generation/release of beta-thromboglobulin (beta-TG), soluble P-selectin (sPS), thrombin (TAT), prothrombin 1 and 2 fragments (PTF1+2), factor XIIa (FXIIa), plasmin (PAP), and D-dimers. Inflammatory (...) Heparin-level-based anticoagulation management during cardiopulmonary bypass: a pilot investigation on the effects of a half-dose aprotinin protocol on postoperative blood loss and hemostatic activation and inflammatory response. Cardiac surgery involving cardiopulmonary bypass (CPB) leads to activation of the hemostatic/inflammatory system. We compared the influence of a half-dose aprotinin regimen on postoperative blood loss and the activation of the hemostatic/inflammatory system during CPB

2004 Anesthesia and analgesia Controlled trial quality: uncertain

1211. Effects of depressive symptoms and anxiety on hemostatic responses to acute mental stress and recovery in the elderly. (Abstract)

Effects of depressive symptoms and anxiety on hemostatic responses to acute mental stress and recovery in the elderly. Depression and anxiety are prospectively associated with cardiac morbidity and mortality. Increased clotting diathesis may mediate this link. We hypothesized that there would be an association between mood and hemostatic changes that occur during and following recovery from acute mental stress. Forty-eight community-dwelling elderly subjects underwent a laboratory speech (...) stressor task. Plasma von Willebrand factor (vWF), thrombin/antithrombin III (TAT) complexes, D-dimer, tissue-type plasminogen activator (t-PA), and type I plasminogen activator inhibitor (PAI-1) were measured at rest, after conclusion of the speech, and 14 min afterwards (recovery). Mood was assessed with the Hamilton Rating Scales for Depression (Ham-D) and Anxiety (Ham-A). Mental stress elicited a hypercoagulable state as evidenced by increases in TAT and D-dimer, and by a decrease in t-PA. Overall

2004 Psychiatry research Controlled trial quality: uncertain

1212. Effects of unfractionated and low molecular weight heparins on plasma levels of hemostatic factors in patients with acute coronary syndromes. (Abstract)

Effects of unfractionated and low molecular weight heparins on plasma levels of hemostatic factors in patients with acute coronary syndromes. Unfractionated heparin (UFH) and enoxaparin (low molecular weight heparin) constitute fundamental therapies in the treatment of patients with acute coronary syndrome (ACS). Since enoxaparin appears to offer clinical advantages over UFH in managing ACS, markers of thrombin generation, endothelial function and acute phase response could manifest different (...) responses to UFH or enoxaparin. The purpose of the present study was to investigate the effect that treatment with either UFH or enoxaparin has on plasma hemostatic markers in 24 patients with ACS.The patients were randomized to receive 5,000 IU intravenous bolus and continuous infusion of 18 IU/Kg/h UFH (n=11) or 1 mg/kg/12h subcutaneous enoxaparin (n=13). The plasma levels of fibrinogen (Fg), prothrombin fragment 1+2 (F1+2), thrombin antithrombin complex (TAT), von Willebrand factor (vWF), tissue

2001 Haematologica Controlled trial quality: uncertain

1213. Effect of four oral contraceptives on hemostatic parameters. (Abstract)

Effect of four oral contraceptives on hemostatic parameters. This is the first double-blind, controlled, randomized study comparing the effect of different estrogen components in oral contraceptives (OCs) on hemostasis variables. Four groups of 25 women each were treated for six cycles with monophasic combinations containing 21 tablets with either 30 microg ethinylestradiol (EE) + 2 mg dienogest (DNG) (30EE/DNG), 20 microg EE + 2 mg DNG (20EE/DNG), 10 microg EE + 2 mg estradiol valerate (EV (...) inhibitor (PAI), and a slight decrease in the sensitivity to activated protein C, but no significant change in that of the thrombin-antithrombin complex. In users of the DNG-containing OCs, the reduction in total and free protein S, and in t-PA and PAI was dependent on the EE dose, while factor VII activity was elevated, but not significantly different from EE/LNG. The results are in agreement with those of previous studies. The effects of EE/EV/DNG on total and free protein S and on t-PA and PAI were

2004 Contraception Controlled trial quality: uncertain

1214. Hemostatic function and progressing ischemic stroke: D-dimer predicts early clinical progression. Full Text available with Trip Pro

recruited. Progressing stroke was defined by deterioration in components of the Scandinavian Stroke Scale. Hemostatic markers (coagulation factors VIIc, VIIIc, and IXc, prothrombin fragments 1+2 [F1+2], thrombin-antithrombin complexes [TAT], D-dimer, fibrinogen, von Willebrand factor [vWF] and tissue plasminogen activator) were measured within 24 hours of symptom recognition.Fifty-four (25%) of the 219 patients met criteria for progressing stroke. F1+2 (median 1.28 versus 1.06 nmol/L, P=0.01), TAT (5.28 (...) predictors of progressing stroke.There is evidence of excess thrombin generation and fibrin turnover in patients with progressing ischemic stroke. Measurement of D-dimer levels can identify patients at high risk for stroke progression. Further research is required to determine whether such patients benefit from acute interventions aimed at modifying hemostatic function.

2004 Stroke

1215. Venous thrombosis and changes of hemostatic variables during cross-sex hormone treatment in transsexual people. Full Text available with Trip Pro

with cyproterone acetate (CPA) only, and with CPA in combination with td E(2), oral EE, or oral E(2) on a number of hemostatic variables [activated protein C (APC) resistance and plasma levels of protein S, protein C, and prothombin], all of which are documented risk factors for venous thrombosis. APC resistance was determined by quantification of the effect of APC on the amount of thrombin generated during tissue factor-initiated coagulation; plasma levels of total and free protein S were determined (...) Venous thrombosis and changes of hemostatic variables during cross-sex hormone treatment in transsexual people. The incidence of venous thrombosis associated with estrogen treatment in male-to-female (M-->F) transsexuals is considerably higher with administration of oral ethinyl estradiol (EE) than with transdermal (td) 17-beta-estradiol (E(2)). To find an explanation for the different thrombotic risks of oral EE and td E(2) use, we compared the effects of treatment of M-->F transsexuals

2003 Journal of Clinical Endocrinology and Metabolism

1216. Effect of Nigella sativa on blood hemostatic function in rats. (Abstract)

Effect of Nigella sativa on blood hemostatic function in rats. Nigella sativa (NS) is consumed excessively in Saudi Arabia and Gulf Countries but few studies were conducted on its effects on hemostasis. The effects of NS on blood coagulation and some liver function tests of normal adult male albino rats were investigated. Equivalent (180mg NS/kg rat/day), half, double, and triple doses of NS powdered seeds incorporated in a flour dough were administered for 1, 2, and 4 weeks. Controls received (...) plain flour dough. At the end of each feeding period, platelet count, prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), levels of fibrinogen, antithrombin III (AT III), and albumin, and activity levels aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were determined. As compared to the control, the equivalent dose of NS induced significant hyperfibrinogenemia (14%) after 4 weeks while the double dose induced significant transient PT

2003 Journal of Ethnopharmacology

1217. Reducing hemostatic activation during cardiopulmonary bypass: a combined approach. (Abstract)

Reducing hemostatic activation during cardiopulmonary bypass: a combined approach. Interventions such as heparin-coated circuits, epsilon-aminocaproic acid, and reduced shed blood reinfusion have shown mixed results when applied individually for limiting hemostatic activation during cardiopulmonary bypass (CPB). We compared coagulation and fibrinolytic activation during conventional CPB (control) (CTRL) using noncoated circuits, no antifibrinolytics, and open cardiotomy with a combined strategy (...) (HAC) that used heparin-coated circuits, epsilon-aminocaproic acid, and closed cardiotomy. Blood samples were drawn before, during, and after CPB for primary coronary bypass grafting surgery from 9 CTRL patients and 10 HAC patients. Thrombin-antithrombin complex and fibrinopeptide A levels (markers of thrombin and fibrin generation) were reduced in the HAC versus CTRL group after 30 min of CPB (P < 0.05). Average tissue plasminogen activator (tPA) levels were significantly lower in the HAC group

2004 Anesthesia and Analgesia

1218. A Study to Compare Human Thrombin Against Bovine Thrombin in Its Ability to Stop Bleeding After Surgery

Verified: August 2007 Additional relevant MeSH terms: Layout table for MeSH terms Thrombin Hemostatics Coagulants (...) A Study to Compare Human Thrombin Against Bovine Thrombin in Its Ability to Stop Bleeding After Surgery A Study to Compare Human Thrombin Against Bovine Thrombin in Its Ability to Stop Bleeding After Surgery - 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

2005 Clinical Trials

1219. A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. (Abstract)

A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. Plasma-derived bovine thrombin is used as a topical agent to improve surgical hemostasis, but development of antibodies to bovine hemostatic proteins has been associated with increased bleeding and thrombotic complications. Recombinant human thrombin could reduce the risk of these complications.The objective of this randomized, double (...) -blind, comparative trial was to compare the efficacy, safety, and antigenicity of recombinant human thrombin (rhThrombin) and bovine thrombin as adjuncts to hemostasis in liver resection, spine, peripheral arterial bypass, and dialysis access surgery. Blinded study drug was applied topically to bleeding sites with an absorbable gelatin sponge. The primary efficacy end point was time to hemostasis, summarized as the incidence of hemostasis within 10 minutes. Safety analyses were conducted for 1 month

2007 Journal of the American College of Surgeons. Controlled trial quality: uncertain

1220. Rapid purification of high purity thrombin and preparation of a novel hemostat for clinical purposes Full Text available with Trip Pro

Rapid purification of high purity thrombin and preparation of a novel hemostat for clinical purposes Thrombin was prepared from crude prothrombin enriched plasma by activation using Russell's viper venom. Prothrombin was prepared by barium sulphate adsorption and elution of prothrombin enriched fraction using high concentrations of sodium citrate. This fraction was directly activated with venom and thrombin was purified by SP Sepharose ion-exchange chromatography and subsequently over Phenyl (...) -sepharose column. This product exhibits a purity of >98% with an activity of at least 6000U/mg or higher. The Thrombin was further used in the preparation of a novel bio-absorbable hemostat using Calcium Alginate fiber sheet which acts as an absorbable hemostat. The present hemostat is highly porous, easy to use and has faster clotting time due to higher solubility of calcium fibers and thereby releasing thrombin.

2008 Indian Journal of Hematology & Blood Transfusion

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