title: The FINISH-3 trial: a phase 3, international, randomized, single-blind, controlled trial of topical fibrocaps in intraoperative surgical hemostasis.
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).
  
  
  METHODS
  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.affiliation: Department of Surgery, Section of Acute and Critical Care Surgery, Washington University School of Medicine, St Louis, MO.
authors.forename: Grant V
authors.initials: GV
authors.lastname: Bochicchio
authors.affiliation: Department of Vascular Surgery, North Shore University Health System, Skokie, IL.
authors.forename: Navyash
authors.initials: N
authors.lastname: Gupta
authors.affiliation: Department of Hepato-Pancreato-Biliary Surgery and Liver Transplantation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Porte
authors.affiliation: Indiana Spine Group, Indianapolis, IN.
authors.forename: Kenneth L
authors.initials: KL
authors.lastname: Renkens
authors.affiliation: Department of Surgery, University Hospital Ghent, Ghent, Belgium.
authors.forename: Piet
authors.initials: P
authors.lastname: Pattyn
authors.affiliation: Department of Abdominal Surgery, UZ Gasthuisberg, Leuven, Belgium.
authors.forename: Baki
authors.initials: B
authors.lastname: Topal
authors.affiliation: Department of General and Hepatobiliary Surgery, UZ Ghent, Ghent, Belgium.
authors.forename: Roberto Ivan
authors.initials: RI
authors.lastname: Troisi
authors.affiliation: Spine Surgery, Las Vegas, NV.
authors.forename: William
authors.initials: W
authors.lastname: Muir
authors.affiliation: Department of Vascular Surgery, University of Hull, East Yorkshire, United Kingdom.
authors.forename: Ian
authors.initials: I
authors.lastname: Chetter
authors.affiliation: Department of Statistics, University of California, Irvine, CA.
authors.forename: Daniel L
authors.initials: DL
authors.lastname: Gillen
authors.affiliation: Clinical Development, ProFibrix Inc. and The Medicines Company, Seattle, WA. Electronic address: linda.zuckerman@themedco.com.
authors.forename: Linda A
authors.initials: LA
authors.lastname: Zuckerman
authors.affiliation: Clinical Development, ProFibrix Inc. and The Medicines Company, Seattle, WA.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Frohna
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016063:Blood Loss, Surgical / Q000517:prevention & control* / Q000706:statistics & numerical data; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000627:therapeutic use*; D005500:Follow-Up Studies; D005780:Gelatin; D006488:Hemostasis, Surgical / Q000379:methods*; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011446:Prospective Studies; D016037:Single-Blind Method; D015503:Surgical Sponges; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D015718:Fibrin Tissue Adhesive; D006490:Hemostatics; D005780:Gelatin