Document Detail


A prospective, randomized trial of topical hemostasis patch use following percutaneous coronary and peripheral intervention.
MedLine Citation:
PMID:  18987396     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The use of topical hemostasis patches has grown rapidly despite a paucity of evidence supporting their clinical utility. We performed a randomized, controlled trial to assess the efficacy of a topical hemostasis patch as a means to accelerate vascular hemostasis following percutaneous intervention. One hundred fifty (150) patients undergoing coronary or peripheral intervention through a 6 Fr femoral arterial sheath were randomized to sheath removal with either: (1) manual pressure and adjunctive use of a patch incorporating a polysaccharide based procoagulant material (SafeSeal Patch, Possis Medical Inc.); or (2) conventional manual pressure alone. Sheaths were removed when the activated clotting time (ACT) fell to < or = 250 seconds. Patients ambulated 2 hours after hemostasis was achieved. Time to hemostasis (duration of compression required until cessation of bleeding following sheath removal) was significantly lower in the hemostasis patch arm (11.8 +/- 3.6 vs. 13.8 +/- 5.8 minutes; p = 0.02). Attainment of hemostasis in < 15 minutes was also more likely among patients randomized to the hemostasis patch rather than manual compression alone (odds ratio = 2.5; 95% confidence intervals 1.2, 5.1; p = 0.014). The median time to ambulation (total duration from the end of the interventional procedure to ambulation) was significantly reduced among patients in the hemostasis patch arm (2.8 vs. 3.8 hours; p = 0.03). Bleeding complications were uncommon and did not differ between the study arms. In conclusion, this trial supports the concept that the polysaccharide-based SafeSeal Patch enhances access site hemostasis following endovascular intervention.
Authors:
Craig R Narins; Wojciech Zareba; Vicki Rocco; Scott McNitt
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Journal of invasive cardiology     Volume:  20     ISSN:  1557-2501     ISO Abbreviation:  J Invasive Cardiol     Publication Date:  2008 Nov 
Date Detail:
Created Date:  2008-11-06     Completed Date:  2009-03-19     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8917477     Medline TA:  J Invasive Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  579-84     Citation Subset:  IM    
Affiliation:
Division of Cardiology, University of Rochester School of Medicine and Dentistry, Rochester, NY 14642, USA. craig_narins@urmc.rochester.edu
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MeSH Terms
Descriptor/Qualifier:
Administration, Topical
Aged
Angioplasty, Transluminal, Percutaneous Coronary / adverse effects*
Coagulants / administration & dosage*
Early Ambulation
Female
Femoral Artery*
Hemorrhage / prevention & control*
Hemostasis, Surgical / methods*
Humans
Male
Middle Aged
Pressure
Prospective Studies
Punctures / adverse effects*
Time Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Coagulants
Comments/Corrections
Comment In:
J Invasive Cardiol. 2008 Nov;20(11):585-6   [PMID:  18987397 ]

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


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