Document Detail


Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures.
MedLine Citation:
PMID:  20730858     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: This study evaluated the safety and haemostatic effectiveness of a fibrin sealant (EVICEL(™) Fibrin Sealant (Human)) during vascular surgery.
METHODS: This prospective randomized controlled trial compared the haemostatic effectiveness of fibrin sealant (75 patients) or manual compression (72) in polytetrafluoroethylene (PTFE) arterial anastomoses. The primary endpoint was the absence of bleeding at the anastomosis at 4 min after randomization. Secondary endpoints included haemostasis at 7 and 10 min, treatment failures and the incidence of complications potentially related to bleeding. Adverse events were recorded.
RESULTS: A higher percentage of patients who received fibrin sealant versus manual compression achieved haemostasis at 4 min (85 versus 39 per cent respectively; odds ratio 11·34, 95 per cent confidence interval 4·67 to 27·52; P < 0·001). Similarly, a higher percentage of patients who received fibrin sealant achieved haemostasis at 7 and 10 min (both P < 0·001). The incidence of treatment failure was lower in the fibrin sealant group (P < 0·001). The rate of complications potentially related to bleeding was similar (P = 0·426). Some 64 per cent of patients who received fibrin sealant experienced at least one adverse event, compared with 71 per cent who received manual compression.
CONCLUSION: This fibrin sealant was safe, and significantly shortened the time to haemostasis in vascular procedures using PTFE. Registration number: NCT00154141 (http://www.clinicaltrials.gov).
Authors:
R T A Chalmers; R C Darling Iii; J T Wingard; I Chetter; B Cutler; J A Kern; J C Hart
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-08-20
Journal Detail:
Title:  The British journal of surgery     Volume:  97     ISSN:  1365-2168     ISO Abbreviation:  Br J Surg     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2010-11-08     Completed Date:  2010-12-27     Revised Date:  2011-01-26    
Medline Journal Info:
Nlm Unique ID:  0372553     Medline TA:  Br J Surg     Country:  England    
Other Details:
Languages:  eng     Pagination:  1784-9     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
Affiliation:
Royal Infirmary of Edinburgh, Edinburgh, UK. rod.chalmers@luht.scot.nhs.uk
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00154141
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Anastomosis, Surgical
Compression Bandages
Female
Fibrin Tissue Adhesive / adverse effects,  therapeutic use*
Great Britain
Hemostasis, Surgical / methods*
Hemostatics / adverse effects,  therapeutic use*
Humans
Male
Middle Aged
Prospective Studies
Tranexamic Acid / adverse effects*
Treatment Outcome
United States
Vascular Surgical Procedures / adverse effects*
Chemical
Reg. No./Substance:
0/Fibrin Tissue Adhesive; 0/Hemostatics; 1197-18-8/Tranexamic Acid
Comments/Corrections
Comment In:
Br J Surg. 2010 Dec;97(12):1790   [PMID:  21058350 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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