• J. Am. Coll. Surg. · Jan 2015

    Randomized Controlled Trial Multicenter Study Comparative Study

    The FINISH-3 trial: a phase 3, international, randomized, single-blind, controlled trial of topical fibrocaps in intraoperative surgical hemostasis.

    • Grant V Bochicchio, Navyash Gupta, Robert J Porte, Kenneth L Renkens, Piet Pattyn, Baki Topal, Roberto Ivan Troisi, William Muir, Ian Chetter, Daniel L Gillen, Linda A Zuckerman, and Paul A Frohna.
    • Department of Surgery, Section of Acute and Critical Care Surgery, Washington University School of Medicine, St Louis, MO.
    • J. Am. Coll. Surg.. 2015 Jan 1;220(1):70-81.

    BackgroundThis Phase 3, international, randomized, single-blind, controlled trial (FINISH-3) compared the efficacy and safety of Fibrocaps, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen, vs gelatin sponge alone for use as a hemostat for surgical bleeding in 4 indications (ie, spinal, hepatic, vascular, soft tissue dissection).Study DesignAdults with mild to moderate surgical bleeding (randomized 2:1; Fibrocaps vs gelatin sponge) were treated at a single bleeding site (day 1). Time to hemostasis (TTH) during 5 minutes was compared (log-rank statistic) within each indication. Safety follow-up continued to day 29.ResultsPatients were treated (Fibrocaps, n = 480; gelatin sponge, n = 239) when undergoing spinal (n = 183), vascular (n = 175), hepatic (n = 180), or soft-tissue (n = 181) procedures. Fibrocaps was applied by spray device in 53% of all procedures (94% of hepatic and soft-tissue procedures). Fibrocaps significantly reduced TTH compared with gelatin sponge; estimated hazard ratios were 3.3, 2.1, 2.3, and 3.4 for the 4 surgical indications, respectively (each p < 0.001; primary end point). Fibrocaps significantly reduced median TTH for each indication (p < 0.001) and was superior for secondary efficacy end points of restricted mean TTH (p < 0.001) and probability of hemostasis at 3 (p < 0.001) and 5 (p ≤ 0.002) minutes. Adverse event incidences were generally similar between treatment arms. Non-neutralizing, anti-thrombin antibodies developed in 2% of Fibrocaps-treated and 3% of gelatin sponge-treated patients.ConclusionsFibrocaps was well tolerated and significantly reduced TTH relative to gelatin sponge alone in all 4 surgical indications. These findings demonstrate the broad utility of Fibrocaps as a hemostatic agent for mild to moderate surgical bleeding.Copyright © 2015 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

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