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Thrombin Hemostatic

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1181. A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. (PubMed)

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

1182. Relative purity of thrombin-based hemostatic agents used in surgery. (PubMed)

Relative purity of thrombin-based hemostatic agents used in surgery. Hemostatic agents used in surgery contain thrombin isolated from either a bovine or human source. The use of thrombin derived from a bovine source has been associated with the development of an abnormal immune response, but a study of the immunoreactivity of the various commercially available thrombin preparations has not been conducted. This study determined the relative purity of commercially available thrombin preparations (...) , if humans have natural antibodies that recognize these preparations, and if elicited antibodies against bovine thrombin cross-react with other bovine or human hemostatic agents.The purity of hemostatic agents was determined by protein and substrate assays, electrophoresis, and immunoblotting. The natural antigenicity and cross-reactivity of elicited antibodies were measured by ELISA using serum samples from 82 donors from the Red Cross and serum collected from patients exposed to bovine thrombin

2003 Journal of the American College of Surgeons

1183. Use of gelatin matrix thrombin tissue sealant as an effective hemostatic agent during laparoscopic partial nephrectomy. (PubMed)

Use of gelatin matrix thrombin tissue sealant as an effective hemostatic agent during laparoscopic partial nephrectomy. We describe a technique for achieving effective hemostasis during laparoscopic partial nephrectomy using gelatin matrix thrombin tissue sealant.Between June 2002 and April 2003, 6 patients underwent laparoscopic partial nephrectomy using the 2-component tissue sealant. Median patient age was 59 years (range 28 to 71) and followup time ranged from 1 to 10 months (median 4.3 (...) ). The tumor was at least 50% exophytic on preoperative computerized tomography and the diameter ranged from 2 to 3 cm (median 2.5). The 2-component tissue sealant, consisting of a gelatin matrix granula component and a thrombin component, was applied after resection of the tumor and before reperfusion of the kidney. Time until complete hemostasis was achieved, postoperative bleeding, estimated blood loss, warm ischemia time and length of surgery were recorded.Hemostasis was immediate in all cases after

2004 Journal of Urology

1184. Thrombin generation in non-cardioembolic stroke subtypes: the Hemostatic System Activation Study. (PubMed)

Thrombin generation in non-cardioembolic stroke subtypes: the Hemostatic System Activation Study. The association between hemostatic activation, stroke mechanism, and outcome is poorly defined. The Hemostatic System Activation Study (HAS) investigators measured serial levels of prothrombin fragment F1.2, a marker of thrombin generation, in patients enrolled in the Warfarin Aspirin Recurrent Stroke Study (WARSS).HAS enrolled 631 of the 2,206 patients in WARSS. Strokes were subtyped according (...) underlying stroke pathophysiology influence thrombin generation in the post-acute stroke period. F1.2 levels were suppressed by warfarin in a dose-dependent fashion. Additional research is needed to determine the predictive value of F1.2 after stroke.

2004 Neurology

1185. Anti-adhesion properties of a thrombin-based hemostatic gelatin in a canine laminectomy model: a biomechanical, biochemical, and histologic study. (PubMed)

Anti-adhesion properties of a thrombin-based hemostatic gelatin in a canine laminectomy model: a biomechanical, biochemical, and histologic study. An in vivo study on the effects of an agent for scar prevention in a dog laminectomy model.To examine the anti-adhesion properties of a thrombin-based hemostatic gelatin (FLOSEAL; Baxter International Inc., Deerfield, IL).Postlaminectomy dural adhesion sometimes causes symptomatic problems. Although a new type of hemostatic agent, a thrombin-based (...) hemostatic gelatin, has been developed, its effect on postlaminectomy scar prevention is unknown.A 4-level lumbar laminectomy was performed on 11 adult mongrel dogs. There were 2 levels randomly chosen to receive the thrombin-based hemostatic gelatin treatment, while the remaining levels were untreated (control). Dogs were euthanized 8 weeks after surgery. To assess the tenacity of adhesion between the dura and scar, peel-off testing was performed. Gross, biochemical, and histologic analyses were

2006 Spine

1186. The effects of argatroban on thrombin generation and hemostatic activation in vitro. (PubMed)

The effects of argatroban on thrombin generation and hemostatic activation in vitro. We evaluated argatroban, a direct thrombin inhibitor, as a heparin adjunct for anticoagulation. Platelet-poor plasma (PPP) was isolated from blood collected from 12 volunteers. Thrombin generation measurements were performed in donor PPP that was mixed with antithrombin (AT)-poor plasma to yield AT levels of 0%, 20%, 60%, and 100%. Effects of argatroban (0-1.0 microg/mL), heparin (0.25 U/mL), or the combination (...) of argatroban (0.5 microg/mL) and heparin were also studied. The addition of increasing concentrations of argatroban, heparin, or both to donor PPP (AT level approximately 100%) caused progressive decreases in the lag time and peak formation of thrombin generation. Heparin (0.25 U/mL) at small AT concentrations had a minimal effect on lag time or peak thrombin formation; its effectiveness of inhibiting thrombin was directly correlated with the concentration of AT. Argatroban at 0.5 microg/mL was effective

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2004 Anesthesia and Analgesia

1187. Hemostatic efficacy of a recombinant thrombin-coated polyglycolic acid sheet coupled with liquid fibrinogen, evaluated in a canine model of pulmonary arterial hemorrhage. (PubMed)

Hemostatic efficacy of a recombinant thrombin-coated polyglycolic acid sheet coupled with liquid fibrinogen, evaluated in a canine model of pulmonary arterial hemorrhage. In thoracic surgery, although infrequent, we encounter unexpected damage to the pulmonary artery (PA). In the present study, we evaluated the hemostatic efficacy of a newly developed fibrin-based sheet material, thrombin sheet, coupled with liquid fibrinogen (TSF), in an experimental model of PA hemorrhage.Female beagles (n (...) in the vicinity of PA, in either group. Histologically, the vessel lumen was well sustained in both groups, with no apparent stenosis or thrombus formation.The hemostatic efficacy of TSF was superior to TC in this particular experiment. Single application of TSF was sufficient to achieve hemostasis in all but one animal. Compression time of approximately 1 minute was also very short albeit that the bleeding was from the PA and not an artery. These results were presumably because the adhesion was stronger

2007 Journal of Trauma

1188. The effectiveness of a fibrinogen-thrombin-collagen-based hemostatic agent in an experimental arterial bleeding model. (PubMed)

The effectiveness of a fibrinogen-thrombin-collagen-based hemostatic agent in an experimental arterial bleeding model. The hemostyptic agent used in this study is a recently developed material that consists of a collagen fleece containing fibrinogen, thrombin, and aprotinin integrated into its surface (FTCH) with excellent topical hemostyptic properties. The potential use of this substance for cardiovascular surgery was evaluated in a canine arterial bleeding model, which allowed comparison (...) and there was no evidence of recurrent bleeding, thrombosis formation, or aneurysmatic changes. Histologic examinations showed well-healed vascular lesions covered by cell-depleted collagen tissue and a partially resorped hemostyptic. FTCH will not replace adequate surgical techniques but could be useful as a quickly available and easily applicable hemostatic means in otherwise uncontrollable diffuse or acute bleeding in cardiovascular surgery.

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1987 Annals of Surgery

1189. Gelatin-thrombin-based hemostatic sealant for intraoperative bleeding in vascular surgery. (PubMed)

Gelatin-thrombin-based hemostatic sealant for intraoperative bleeding in vascular surgery. Vascular surgical procedures may be prolonged because of intraoperative bleeding that is not easily controlled by cautery or suture ligation. This trial compared the ability of a new hemostat, FloSealTM Matrix (FM), with a known hemostat, Gelfoam(R) plus thrombin (GT), to control intraoperative bleeding. Patients undergoing vascular surgery procedures at four institutions were entered in the trial. After (...) at 30 days and 6-8 weeks after the operation. Analysis was performed on an intent-to-treat basis for analysis of hemostasis at 10 min and on protocol-valid patients for analysis of time to hemostasis. From our results we concluded that for patients undergoing vascular surgery procedures, the new topical hemostat, FloSeal Matrix, provides more rapid and effective hemostasis than Gelfoam plus thrombin.

2002 Annals of vascular surgery Controlled trial quality: uncertain

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