Grant V Bochicchio1, Navyash Gupta2, Robert J Porte3, Kenneth L Renkens4, Piet Pattyn5, Baki Topal6, Roberto Ivan Troisi7, William Muir8, Ian Chetter9, Daniel L Gillen10, Linda A Zuckerman11, Paul A Frohna12. 1. Department of Surgery, Section of Acute and Critical Care Surgery, Washington University School of Medicine, St Louis, MO. 2. Department of Vascular Surgery, North Shore University Health System, Skokie, IL. 3. Department of Hepato-Pancreato-Biliary Surgery and Liver Transplantation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. 4. Indiana Spine Group, Indianapolis, IN. 5. Department of Surgery, University Hospital Ghent, Ghent, Belgium. 6. Department of Abdominal Surgery, UZ Gasthuisberg, Leuven, Belgium. 7. Department of General and Hepatobiliary Surgery, UZ Ghent, Ghent, Belgium. 8. Spine Surgery, Las Vegas, NV. 9. Department of Vascular Surgery, University of Hull, East Yorkshire, United Kingdom. 10. Department of Statistics, University of California, Irvine, CA. 11. Clinical Development, ProFibrix Inc. and The Medicines Company, Seattle, WA. Electronic address: linda.zuckerman@themedco.com. 12. Clinical Development, ProFibrix Inc. and The Medicines Company, Seattle, WA.
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.
RCT Entities:
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.
Authors: Daniel J Del Gaizo; William D Spotnitz; Rachel W Hoffman; Mark Christopher Hermann; Linda S Sher; Russell H Spotnitz; Yuri S Genyk; Ian J Schorn; Daniel L Gillen; Bobby L White; Bruce G Miller; Roberto J Manson Journal: Clin Appl Thromb Hemost Date: 2020 Jan-Dec Impact factor: 2.389