Grant V. Bochicchio
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
Navyash Gupta
Robert J. Porte
Kenneth L. Renkens
Piet Pattyn
Baki Topal
Roberto Ivan Troisi
William Muir
Professor Ian Chetter I.Chetter@hull.ac.uk
Professor of Vascular Surgery
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. |
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