title: A prospective, randomized trial of topical hemostasis patch use following percutaneous coronary and peripheral intervention.
abstract: 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.affiliation: Division of Cardiology, University of Rochester School of Medicine and Dentistry, Rochester, NY 14642, USA. craig_narins@urmc.rochester.edu
authors.forename: Craig R
authors.initials: CR
authors.lastname: Narins
authors.forename: Wojciech
authors.initials: W
authors.lastname: Zareba
authors.forename: Vicki
authors.initials: V
authors.lastname: Rocco
authors.forename: Scott
authors.initials: S
authors.lastname: McNitt
mesh_terms: D000287:Administration, Topical; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects*; D003029:Coagulants / Q000008:administration & dosage*; D004434:Early Ambulation; D005260:Female; D005263:Femoral Artery; D006470:Hemorrhage / Q000517:prevention & control*; D006488:Hemostasis, Surgical / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011312:Pressure; D011446:Prospective Studies; D011677:Punctures / Q000009:adverse effects*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D003029:Coagulants