TY - JOUR
T1 - The FINISH-3 trial
T2 - A phase 3, international, randomized, single-blind, controlled trial of topical fibrocaps in intraoperative surgical hemostasis
AU - Bochicchio, Grant V.
AU - Gupta, Navyash
AU - Porte, Robert J.
AU - Renkens, Kenneth L.
AU - Pattyn, Piet
AU - Topal, Baki
AU - Troisi, Roberto Ivan
AU - Muir, William
AU - Chetter, Ian
AU - Gillen, Daniel L.
AU - Zuckerman, Linda A.
AU - Frohna, Paul A.
N1 - Funding Information:
Principal investigators enrolling patients in this trial: Thomas Biehl, MD, Virginia Mason Medical Center, Seattle, WA; Stephen Blair, MS, FRCS, Arrowe Park Hospital, Wirral, UK; Grant Bochicchio, MD, MPH, Washington University School of Medicine, St Louis, MO; William Chapman, MD, Washington University School of Medicine, St Louis, MO; Ian Chetter, MD, PhD, Hull Royal Infirmary, Hull, UK; Johannes de Wilt, MD, PhD, St Radboud University Medical Centre, Nijmegen, NL; Olivier DeWitte, MD, PhD, Hôpital Erasme, Bruxelles, BE; Patrick Fransen, MD, Clinique du Park Léopold, CHRIEC, Brussels, BE; Robert Geelkerken, MD, PhD, Medisch Spectrum Twente, Enschede, NL; Kathleen Gibson, MD, Lake Washington Vascular Surgeons, Bellevue, WA; Navyash Gupta, MD, FACS, North Shore University Health System, Skokie, IL; Jacob Hamming, MD, PhD, Leiden University Medical Center, Leiden, NL; Stephen Hansen, MD, The Smart Clinic, Sandy, UT; Paul Hayes, MD, Addenbrooke's Hospital, Cambridge, UK; Nigel Heaton, MD, BS, FRCS, King's College Hospital, London, UK; Kim Hodgson, MD, Memorial Medical Center, Springfield, IL; Christopher Imray, PhD FRCS, FRCP, MB, BS, University Hospital, Coventry, UK; William Jordan, MD, University Hospital, Birmingham, AL; Joost Klaase, MD, PhD, Medisch Spectrum Twente, Enschede, NL; Shankar Lakshman, MD, Lotus Clinical Research, LLC, Pasadena, CA; Jan Willem Lardenoije, MD, Rijnstate Ziekenhuis - Locatie Arnhem, NL; Max Lehfeldt, MD, Lotus Clinical Research, LLC, Pasadena, CA; Harry Lockstadat, MD, Bluegrass Orthopaedics & Hand Care Research, Lexington, KY; Ian Loftus, MD, St Georges University London, London, UK; Charles McCollum, MD, University Hospital of South Manchester, Manchester, UK; Gregory Moneta, MD, Oregon Health & Science University, Portland, OR; William Morris, MD, MultiCare Health System Research Institute, Tacoma, WA; William Muir, MD, Spine Surgery, Las Vegas, NV; Albert O-Yurvati, DO, FACOS, FICS, FAHA, University of North Texas Health Science Center at Fort Worth, Fort Worth, TX; Ashit Patel, MD, Overlake Hospital Medical Center, Bellevue, WA; Piet Pattyn, MD, PhD, University Hospital Ghent, Ghent, BE; William Pearce, MD, Northwestern University, Chicago, IL; Woolagasen Pillay, FCS(SA), MMedSc, Doncaster Royal Infirmary, Doncaster, UK; Robert Porte, MD, PhD, University Medical Center Groningen, NL; Kenneth Renkens, MD, Indiana Spine Group, Carmel, IN; Arjen Rijken, MD, PhD, Amphia Hospital, Breda, NL; Thomas Rose, MD, Militair Hospitaal Koningin Astrid, Brussels, BE; David Russell, MD, Leeds General Infirmary, Leeds, UK; Surendra Shenoy, MD, Washington University School of Medicine, St Louis, MO; Linda Sher, MD, Keck Medical Center of USC, Los Angeles, CA; Neil Singla, MD, Lotus Clinical Research, LLC, Pasadena, CA; Sonia Singla, DO, Lotus Clinical Research, LLC, Pasadena, CA; Gerard Stansby, BA, MD, Chir MA, FRCS, M Chir, Freeman Hospital, Newcastle Upon Tyne, UK; Robert Sutcliffe, MD, Queen Elizabeth Hospital, Birmingham UK; Thomas Taylor, MD, Lotus Clinical Research, LLC, Pasadena, CA; Andrew Thompson, MD, The York Hospital, York, UK; Antioine Tohmeh, MD, Northwest Orthopaedic Specialists, PS, Spokane, WA; Baki Topal, MD, PhD, UZ Gasthuisberg, Leuven, BE; Roberto Ivan Troisi, MD, PhD, FEBS, UZ Ghent, Ghent, BE; Lijckle van der Laan, MD, PhD, Amphia Hospital, Breda, NL; Jordanus van Der Vliet, MD, PhD, St Radboud University Medical Centre, Nijmegen, NL; Cornelis Verhoef, MD, PhD, Erasmus MC, Rotterdam NL; Alan Villavicencio, MD, Boulder Neurosurgical Associates, Boulder, CO; Karen Woo, MD, Keck Medical Center of USC, Los Angeles, CA; Clark Zeebregts, MD, PhD, University Medical Center, Groningen, NL. Members of the independent data monitoring committee: Scott Emerson, MD, PhD, University of Washington, Seattle, WA; Brian Davidson, MD, FRCS, University College London, London, UK; Thomas Reynolds, MD, PhD, Seattle Genetics, Bothell, WA; Peter Whang, MD, Yale University School of Medicine, New Haven, CT; and Samuel Wilson, MD, University of California, Irvine, Orange, CA. The authors thank John Pribble, PharmD of The Medicines Company for his assistance with the manuscript. Kate Loughney, PhD, provided medical writing assistance under the sponsorship of ProFibrix Inc/The Medicines Company.
PY - 2015/1/1
Y1 - 2015/1/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84916897878&partnerID=8YFLogxK
U2 - 10.1016/j.jamcollsurg.2014.09.019
DO - 10.1016/j.jamcollsurg.2014.09.019
M3 - Article
C2 - 25458801
AN - SCOPUS:84916897878
SN - 1072-7515
VL - 220
SP - 70
EP - 81
JO - Journal of the American College of Surgeons
JF - Journal of the American College of Surgeons
IS - 1
ER -