title: Randomized trial of a dry-powder, fibrin sealant in vascular procedures.
abstract: OBJECTIVE
  Topical hemostats are important adjuncts for stopping surgical bleeding. The safety and efficacy of Fibrocaps, a dry-powder, fibrin sealant containing human plasma-derived thrombin and fibrinogen, was evaluated in patients undergoing vascular surgical procedures.
  
  
  METHODS
  In this single-blind trial (clinicaltrials.gov: NCT01527357), adult patients were randomized 2:1 to Fibrocaps plus gelatin sponge (Fibrocaps) vs gelatin sponge alone. Results are presented for the patient subset undergoing vascular procedures with suture hole bleeding. The primary efficacy endpoint compared time to hemostasis (TTH) over 5 minutes. Safety follow-up continued to day 29.
  
  
  RESULTS
  A total of 175 patients were randomized and treated (Fibrocaps, 117; gelatin sponge, 58). Patients were predominately male (69%) and underwent arterial bypass (81%), arteriovenous graft formation (9%), or carotid endarterectomy (9%). Fibrocaps significantly reduced TTH compared with gelatin sponge (hazard ratio [HR], 2.1; 95% confidence interval [CI], 1.5-3.1; median TTH, 2 minutes; 95% CI, 1.5-2.5 vs 4 minutes; 95% CI, 3.0-5.0; P < .002). Significant reductions were also observed in patients receiving concomitant antiplatelet agents alone (HR, 2.8; 95% CI, 1.0-7.4; P = .03; n = 33), anticoagulants alone (HR, 2.0; 95% CI, 1.0-4.0; P = .04; n = 43), or both antiplatelet agents and anticoagulants (Fibrocaps vs gelatin sponge, HR, 2.3; 95% CI, 1.2-4.3; P = .008; n = 65). Incidences of common adverse events (procedural pain, nausea, constipation) were generally comparable between treatment arms. Anti-thrombin antibodies developed in 2% of Fibrocaps-treated patients and no-gelatin-sponge patients.
  
  
  CONCLUSIONS
  Fibrocaps, a ready-to-use, dry-powder fibrin sealant, was well-tolerated and reduced TTH in patients undergoing vascular procedures, including those receiving antiplatelet agents and/or anticoagulants, demonstrating its safety and usefulness as an adjunct to hemostasis.
authors.affiliation: Division of Vascular Surgery, NorthShore University HealthSystem, Skokie, Ill.
authors.forename: NavYash
authors.initials: N
authors.lastname: Gupta
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 Vascular Surgery, Addenbrooke's Hospital, Cambridge, United Kingdom.
authors.forename: Paul
authors.initials: P
authors.lastname: Hayes
authors.affiliation: Department of Surgery, University of North Texas Health Science Center, Fort Worth, Tex.
authors.forename: Albert H
authors.initials: AH
authors.lastname: O-Yurvati
authors.affiliation: Division of Vascular Surgery, Oregon Health & Science University Hospital & Clinic, Portland, Ore.
authors.forename: Gregory L
authors.initials: GL
authors.lastname: Moneta
authors.affiliation: Division of General Surgery, Section of Transplantation Surgery, Washington University School of Medicine, St. Louis, Mo.
authors.forename: Surendra
authors.initials: S
authors.lastname: Shenoy
authors.affiliation: The Medicines Company, Seattle, Wash.
authors.forename: John P
authors.initials: JP
authors.lastname: Pribble
authors.affiliation: The Medicines Company, Seattle, Wash. Electronic address: linda.zuckerman@themedco.com.
authors.forename: Linda A
authors.initials: LA
authors.lastname: Zuckerman
mesh_terms: D000287:Administration, Topical; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000008:administration & dosage* / Q000009:adverse effects; D005781:Gelatin Sponge, Absorbable; D006489:Hemostatic Techniques; D006490:Hemostatics / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D011208:Powders; D012307:Risk Factors; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D014481:United States; D014656:Vascular Surgical Procedures / Q000009:adverse effects*
chemical_list: D000925:Anticoagulants; D015718:Fibrin Tissue Adhesive; D006490:Hemostatics; D010975:Platelet Aggregation Inhibitors; D011208:Powders