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

Bochicchio, Grant V.; Gupta, Navyash; Porte, Robert J.; Renkens, Kenneth L.; Pattyn, Piet; Topal, Baki; Troisi, Roberto Ivan; Muir, William; Chetter, Ian; Gillen, Daniel L.; Zuckerman, Linda A.; Frohna, Paul A.

Authors

Grant V. Bochicchio

Navyash Gupta

Robert J. Porte

Kenneth L. Renkens

Piet Pattyn

Baki Topal

Roberto Ivan Troisi

William Muir

Daniel L. Gillen

Linda A. Zuckerman

Paul A. Frohna



Abstract

Background This 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 Design Adults 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. Results Patients 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. Conclusions Fibrocaps 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.

Citation

Bochicchio, G. V., Gupta, N., Porte, R. J., Renkens, K. L., Pattyn, P., Topal, B., …Frohna, P. A. (2015). The FINISH-3 trial: A phase 3, international, randomized, single-blind, controlled trial of topical fibrocaps in intraoperative surgical hemostasis. Journal of The American College of Surgeons, 220(1), 70-81. https://doi.org/10.1016/j.jamcollsurg.2014.09.019

Journal Article Type Article
Acceptance Date Sep 19, 2014
Online Publication Date Oct 13, 2014
Publication Date 2015-01
Journal Journal of the American College of Surgeons
Print ISSN 1072-7515
Electronic ISSN 1879-1190
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 220
Issue 1
Pages 70-81
DOI https://doi.org/10.1016/j.jamcollsurg.2014.09.019
Keywords Surgery
Public URL https://hull-repository.worktribe.com/output/432715
Publisher URL http://www.sciencedirect.com/science/article/pii/S1072751514017165?_rdoc=1&_fmt=high&_origin=gateway&_docanchor=&md5=b8429449ccfc9c30159a5f9aeaa92ffb
Additional Information This article is maintained by: Elsevier; Article Title: The FINISH-3 Trial: A Phase 3, International, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps in Intraoperative Surgical Hemostasis; Journal Title: Journal of the American College of Surgeons; CrossRef DOI link to publisher maintained version: http://dx.doi.org/10.1016/j.jamcollsurg.2014.09.019; Content Type: article; Copyright: Copyright © 2015 American College of Surgeons. Published by Elsevier Inc. All rights reserved.