title: Fibrocaps for surgical hemostasis: two randomized, controlled phase II trials.
abstract: BACKGROUND
  Fibrocaps, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen, is being developed as an adjunct for surgical hemostasis.
  
  
  METHODS
  Safety and efficacy of Fibrocaps applied directly or by spray device, in combination with gelatin sponge, was compared with that of gelatin sponge-alone in two randomized, single-blind controlled trials: FC-002 US (United States) and FC-002 NL (the Netherlands). A total of 126 adult patients were randomized (Fibrocaps: n = 47 [FC-002 US], n = 39 [FC-002 NL]; gelatin sponge alone: n = 23 [FC-002 US], n = 17 [FC-002 NL). One bleeding site was treated during a surgical procedure (n = 125). Time to hemostasis (primary end point) was measured, with a 28-d safety follow-up. Four surgical indications included hepatic resection (n = 58), spinal procedures (n = 37), peripheral vascular procedures (n = 30), and soft tissue dissection (n = 1).
  
  
  RESULTS
  Mean (standard deviation) time to hemostasis was significantly shorter after Fibrocaps treatment than after gelatin sponge alone (FC-002 US: 1.9 [1.3] versus 4.8 min [3.1], P < 0.001; FC-002 NL: 2.2 [1.3] versus 4.4 min [3.1], P = 0.004). The incidence of hemostasis was greater after Fibrocaps compared with that of gelatin sponge alone within 3 min (FC-002 US: 83% versus 35%, P < 0.001; FC-002 NL: 77% versus 53%, P = 0.11), 5 min (94% versus 61%, P = 0.001; 95% versus 71%, P = 0.022), and 10 min (100% versus 78%, P = 0.003; 100% versus 82%, P = 0.025). Adverse events were consistent with surgical procedures performed and patients' underlying diseases and generally similar between treatment arms; most were mild or moderate in severity. Non-neutralizing antithrombin antibodies were detected in 5% of Fibrocaps-treated patients on day 29.
  
  
  CONCLUSIONS
  Fibrocaps had good safety and efficacy profiles, supporting continuing clinical development as a novel fibrin sealant.
authors.affiliation: Department of Surgical Oncology, Erasmus Medical Center Cancer Institute, Rotterdam, The Netherlands.
authors.forename: Cornelis
authors.initials: C
authors.lastname: Verhoef
authors.affiliation: Department of Anesthesia, Lotus Clinical Research, Huntington Hospital, Pasadena, California.
authors.forename: Neil
authors.initials: N
authors.lastname: Singla
authors.affiliation: Division of Vascular Surgery, Oregon Health & Science University Hospital and Clinic, Portland, Oregon.
authors.forename: Greg
authors.initials: G
authors.lastname: Moneta
authors.affiliation: William S. Muir MD Spine Surgery, Las Vegas, Nevada.
authors.forename: William
authors.initials: W
authors.lastname: Muir
authors.affiliation: Department of Surgery, Amphia Hospital, Breda, The Netherlands.
authors.forename: Arjen
authors.initials: A
authors.lastname: Rijken
authors.affiliation: Bluegrass Orthopedics, Lexington, Kentucky.
authors.forename: Harry
authors.initials: H
authors.lastname: Lockstadt
authors.affiliation: Division of Surgical Oncology and Gastrointestinal Surgery, Radboud Univeristy Medical Center, Nijmegen, The Netherlands.
authors.forename: Johannes H W
authors.initials: JHW
authors.lastname: de Wilt
authors.affiliation: Department of Surgery, University of North Texas Health Science Center, Fort Worth, Texas.
authors.forename: Albert
authors.initials: A
authors.lastname: O-Yurvati
authors.affiliation: Department of Clinical Research, ProFibrix BV, The Medicines Company, Seattle, Washington. Electronic address: linda.zuckerman@themedco.com.
authors.forename: Linda A
authors.initials: LA
authors.lastname: Zuckerman
authors.affiliation: Department of Clinical Research, ProFibrix BV, The Medicines Company, Seattle, Washington.
authors.forename: Paul
authors.initials: P
authors.lastname: Frohna
authors.affiliation: Department of Surgery, Section Surgery and Liver Transplantation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Porte
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000276:immunology / Q000627:therapeutic use*; D005781:Gelatin Sponge, Absorbable; D006488:Hemostasis, Surgical / Q000295:instrumentation*; D006490:Hemostatics / Q000276:immunology / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D015718:Fibrin Tissue Adhesive; D006490:Hemostatics
keywords: Dry powder; Fibrin sealant; Fibrinogen and thrombin; Hepatic surgery; Soft tissue dissection; Spinal surgery; Vascular surgery