The FINISH-3 Trial: A Phase 3, International, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps in Intraoperative Surgical Hemostasis

• Published in: Journal of the American College of Surgeons Vol. 220; no. 1; pp. 70 - 81
• Main Authors: Bochicchio, Grant V., MD, MPH, FACS, Gupta, Navyash, MD, FACS, Porte, Robert J., MD, PhD, Renkens, Kenneth L., MD, FACS, Pattyn, Piet, MD, PhD, Topal, Baki, MD, PhD, Troisi, Roberto Ivan, MD, PhD, FEBS, Muir, William, MD, Chetter, Ian, MD, PhD, Gillen, Daniel L., PhD, Zuckerman, Linda A., PhD, Frohna, Paul A., MD, PhD, PharmD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 2015
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Blood Loss, Surgical - prevention & control; Blood Loss, Surgical - statistics & numerical data; Female; Fibrin Tissue Adhesive - therapeutic use; Follow-Up Studies; Gelatin; Hemostasis, Surgical - methods; Hemostatics - therapeutic use; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Proportional Hazards Models; Prospective Studies; Single-Blind Method; Surgery; Surgical Sponges; Treatment Outcome; Young Adult
• ISSN: 1072-7515; 1879-1190
• DOI: 10.1016/j.jamcollsurg.2014.09.019

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.