Document Detail

A prospective randomized study comparing fibrin sealant to manual compression for the treatment of anastomotic suture-hole bleeding in expanded polytetrafluoroethylene grafts.
MedLine Citation:
PMID:  22633423     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: The ideal hemostatic agent for treatment of suture-line bleeding at vascular anastomoses has not yet been established. This study evaluated whether the use of a fibrin sealant containing 500 IU/mL thrombin and synthetic aprotinin (FS; marketed in the United States under the name TISSEEL) is beneficial for treatment of challenging suture-line bleeding at vascular anastomoses of expanded polytetrafluoroethylene (ePTFE) grafts, including those further complicated by concomitant antiplatelet therapies.
METHODS: Over a 1-year period ending in 2010, ePTFE graft prostheses, including arterio-arterial bypasses and arteriovenous shunts, were placed in 140 patients who experienced suture-line bleeding that required treatment after completion of anastomotic suturing. Across 24 US study sites, 70 patients were randomized and treated with FS and 70 with manual compression (control). The primary end point was the proportion of patients who achieved hemostasis at the study suture line at 4 minutes after start of application of FS or positioning of surgical gauze pads onto the study suture line.
RESULTS: There was a statistically significant difference in the comparison of hemostasis rates at the study suture line at 4 minutes between FS (62.9%) and control (31.4%) patients (P < .0001), which was the primary end point. Similarly, hemostasis rates in the subgroup of patients on antiplatelet therapies were 64.7% (FS group) and 28.2% (control group). When analyzed by bleeding severity, the hemostatic advantage of FS over control at 4 minutes was similar (27.8% absolute improvement for moderate bleeding vs 32.8% for severe bleeding). Logistic regression analysis (accounting for gender, age, intervention type, bleeding severity, blood pressure, heparin coating of ePTFE graft, and antiplatelet therapies) found a statistically significant treatment effect in the odds ratio (OR) of meeting the primary end point between treatment groups (OR, 6.73; P < .0001), as well as statistically significant effects for intervention type (OR, 0.25; P = .0055) and bleeding severity (OR, 2.59; P = .0209). The safety profile of FS was excellent as indicated by the lack of any related serious adverse events.
CONCLUSIONS: The findings from this phase 3 study confirmed that FS is safe and its efficacy is superior to manual compression for hemostasis in patients with peripheral vascular ePTFE grafts. The data also suggest that FS promotes hemostasis independently of the patient's own coagulation system, as shown in a representative population of patients with vascular disease under single- or dual-antiplatelet therapies.
Sibu P Saha; Satish Muluk; Worthington Schenk; James W Dennis; Bettina Ploder; Ani Grigorian; Isabella Presch; Andreas Goppelt
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Publication Detail:
Type:  Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2012-05-25
Journal Detail:
Title:  Journal of vascular surgery     Volume:  56     ISSN:  1097-6809     ISO Abbreviation:  J. Vasc. Surg.     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-07-03     Completed Date:  2012-09-20     Revised Date:  2012-10-03    
Medline Journal Info:
Nlm Unique ID:  8407742     Medline TA:  J Vasc Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  134-41     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.
Division of Cardiovascular and Thoracic Surgery, Department of Surgery, University of Kentucky, Lexington, KY, USA.
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MeSH Terms
Aged, 80 and over
Anastomosis, Surgical
Blood Loss, Surgical / prevention & control*
Blood Vessel Prosthesis*
Blood Vessel Prosthesis Implantation*
Chi-Square Distribution
Fibrin Tissue Adhesive / therapeutic use*
Hemostasis, Surgical / methods*
Hemostatics / therapeutic use*
Logistic Models
Middle Aged
Platelet Aggregation Inhibitors / therapeutic use
Prospective Studies
Risk Factors
Single-Blind Method
Suture Techniques
Treatment Outcome
Reg. No./Substance:
0/Fibrin Tissue Adhesive; 0/Hemostatics; 0/Platelet Aggregation Inhibitors; 9002-84-0/Polytetrafluoroethylene

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

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