| A prospective, randomized trial of topical hemostasis patch use following percutaneous coronary and peripheral intervention. | |
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MedLine Citation:
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PMID: 18987396 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Craig R Narins; Wojciech Zareba; Vicki Rocco; Scott McNitt |
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Publication Detail:
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Type: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The Journal of invasive cardiology Volume: 20 ISSN: 1557-2501 ISO Abbreviation: J Invasive Cardiol Publication Date: 2008 Nov |
Date Detail:
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Created Date: 2008-11-06 Completed Date: 2009-03-19 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8917477 Medline TA: J Invasive Cardiol Country: United States |
Other Details:
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Languages: eng Pagination: 579-84 Citation Subset: IM |
Affiliation:
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Division of Cardiology, University of Rochester School of Medicine and Dentistry, Rochester, NY 14642, USA. craig_narins@urmc.rochester.edu |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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0/Coagulants |
| Comments/Corrections | |
Comment In:
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J Invasive Cardiol. 2008 Nov;20(11):585-6
[PMID:
18987397
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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