Randomized trial of a dry-powder, fibrin sealant in vascular procedures Abstract based on results presented at Society of Academic and Research Surgery meeting, Durham University, Durham, UK, January 7-8, 2015.

Nav Yash Gupta, Ian Chetter, Paul Hayes, Albert H. Albert, Gregory L. Moneta, Surendra Shenoy, John P. Pribble, Linda A. Zuckerman

    Research output: Contribution to journalArticle

    8 Scopus citations

    Abstract

    Objective Topical hemostats are important adjuncts for stopping surgical bleeding. The safety and efficacy of Fibrocaps, a dry-powder, fibrin sealant containing human plasma-derived thrombin and fibrinogen, was evaluated in patients undergoing vascular surgical procedures. Methods In this single-blind trial (clinicaltrials.gov: NCT01527357), adult patients were randomized 2:1 to Fibrocaps plus gelatin sponge (Fibrocaps) vs gelatin sponge alone. Results are presented for the patient subset undergoing vascular procedures with suture hole bleeding. The primary efficacy endpoint compared time to hemostasis (TTH) over 5 minutes. Safety follow-up continued to day 29. Results A total of 175 patients were randomized and treated (Fibrocaps, 117; gelatin sponge, 58). Patients were predominately male (69%) and underwent arterial bypass (81%), arteriovenous graft formation (9%), or carotid endarterectomy (9%). Fibrocaps significantly reduced TTH compared with gelatin sponge (hazard ratio [HR], 2.1; 95% confidence interval [CI], 1.5-3.1; median TTH, 2 minutes; 95% CI, 1.5-2.5 vs 4 minutes; 95% CI, 3.0-5.0; P <.002). Significant reductions were also observed in patients receiving concomitant antiplatelet agents alone (HR, 2.8; 95% CI, 1.0-7.4; P =.03; n = 33), anticoagulants alone (HR, 2.0; 95% CI, 1.0-4.0; P =.04; n = 43), or both antiplatelet agents and anticoagulants (Fibrocaps vs gelatin sponge, HR, 2.3; 95% CI, 1.2-4.3; P =.008; n = 65). Incidences of common adverse events (procedural pain, nausea, constipation) were generally comparable between treatment arms. Anti-thrombin antibodies developed in 2% of Fibrocaps-treated patients and no-gelatin-sponge patients. Conclusions Fibrocaps, a ready-to-use, dry-powder fibrin sealant, was well-tolerated and reduced TTH in patients undergoing vascular procedures, including those receiving antiplatelet agents and/or anticoagulants, demonstrating its safety and usefulness as an adjunct to hemostasis.

    Original languageEnglish (US)
    Pages (from-to)1288-1295
    Number of pages8
    JournalJournal of vascular surgery
    Volume62
    Issue number5
    DOIs
    StatePublished - Nov 2015

    ASJC Scopus subject areas

    • Surgery
    • Cardiology and Cardiovascular Medicine

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