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A Randomized Trial of Aprotinin-Free Fibrin Sealant Versus Absorbable Hemostat.
MedLine Citation:
PMID:  21873356     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Background: This study evaluated the safety and hemostatic effectiveness of a tranexamic acid- and aprotinin-free fibrin sealant versus an absorbable hemostat in soft tissue during elective retroperitoneal or intra-abdominal surgery. Materials and Methods: This randomized, active-controlled, multicenter study enrolled patients who were undergoing elective retroperitoneal or intra-abdominal surgery and required adjunctive hemostatic measures at the target bleeding site (TBS). Patients were randomized (time = 0 minutes) to receive fibrin sealant or absorbable hemostat. The primary endpoint was the absence of bleeding at the TBS at 10 minutes. Secondary endpoints included the absence of bleeding at 4 and 7 minutes and the incidence of treatment failure (bleeding at 10 minutes or brisk bleeding requiring additional hemostatic measures), and the incidence of complications potentially related to bleeding. Adverse events were assessed. Results: Patients (N = 124) were randomized to receive fibrin sealant (n = 62) or absorbable hemostat (n = 62). A higher percentage of patients who received fibrin sealant versus absorbable hemostat achieved hemostasis within 10 minutes (95.2% vs 82.3%; 95% CI, 1.02-1.35) and also at 4 (74.2% vs 54.8%; 95% CI, 1.04-1.80) and 7 (90.3% vs 77.4%; 95% CI, 1.00-1.39) minutes. A lower incidence of treatment failure was observed for patients receiving fibrin sealant. Similar incidences of adverse events and complications potentially related to bleeding were observed. Conclusions: This tranexamic acid- and aprotinin-free fibrin sealant is safe and effective for achieving hemostasis in soft tissue during elective retroperitoneal or intra-abdominal surgery.
Authors:
Craig P Fischer; Christopher G Wood; Jessica Shen; Jonathan Batiller; James C Hart; Bababhai Patel; David M Albala
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-8-25
Journal Detail:
Title:  Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis     Volume:  -     ISSN:  1938-2723     ISO Abbreviation:  -     Publication Date:  2011 Aug 
Date Detail:
Created Date:  2011-8-29     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9508125     Medline TA:  Clin Appl Thromb Hemost     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
The Methodist Hospital and Weill Medical College of Cornell University, Houston, TX, USA.
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