Clinical Trials and Studies

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The primary objective of the study is to demonstrate the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis in subjects with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery. This is a Phase 3, international, multi-center, randomized, single-blind, controlled trial that will be conducted at clinical trial sites in the European Union and United States.


Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion Criteria

  • Subject has signed an institutional review board/independent ethics committee (IRB/IEC)-approved informed consent document
  • Subject is undergoing one of the 4 surgical procedures described
  • Subject age is >18 years at time of consent
  • If female and of child-bearing potential, subject has negative pregnancy test during screening and is not breast-feeding
  • If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
  • Subject has not received blood transfusion between screening and study treatment
  • Presence of mild to moderate surgical bleeding
  • Absence of intra-operative complications
  • No intra-operative use of a topical hemostat containing thrombin prior to study treatment
  • Approximate bleeding site surface area of less than or equal to 100 cm2

  • Subject has known antibodies or hypersensitivity to thrombin or other coagulation factors
  • Subject has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required)
  • Subject has known allergy to porcine gelatin
  • Subject is unwilling to receive blood products
  • Has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the Investigator, or baseline abnormalities of INR > 2.5 or aPTT > 100 seconds during screening that are not explained by current drug treatment (e.g., warfarin, heparin)
  • Aspartate Aminotransferase (ASAT/AST ) or Alanine aminotransferase (ALAT/ALT) > 3 x upper limit normal range during screening, except for subjects undergoing liver resection surgery or with a diagnosis of liver metastases where there is no upper limit for these analytes due to the nature of their disease
  • Platelets < 100 x109 PLT/L during screening


  • California

    • University of Southern California, Keck School of Medicine, Los Angeles, California, 90033
    • University of Southern California/Norris Comprehensive Cancer Center, Los Angeles, California, 90033
    • Lotus Clinical Research, LLC, Pasadna, California, 91105
    • Vascular Interventional Specialists of Orange County, Orange, California, 92868
  • Nevada

    • William Muir MD Spine Surgery, Las Vegas, Nevada, 89144
  • Utah

    • Physician's Research Options, Sandy, Utah, 84070
  • Colorado

    • Spine Colorado, Durango, Colorado, 81303
    • Boulder Neurological Institute, Boulder, Colorado, 80304
  • Washington

    • Multicare Neuroscience Center of Washington, Tacoma, Washington, 98405
    • Northwest Orthopaedic Specialists, P.S., Spokane, Washington, 99208
    • Overlake Hospital Medical Center, Bellevue, Washington, 98004
    • Virginia Mason Medical Center, Seattle, Washington, 98101
  • Texas

    • University of North Texas Health Sciences Center, Fort Worth, Texas, 76107
  • Oklahoma

    • The University of Oklahoma - Tulsa, Tulsa, Oklahoma, 74135
  • Missouri

    • Washington University School of Medicine, St. Louis, Missouri, 63110
  • Illinois

    • Southern Illinois University School of Medicine, Springfield, Illinois, 62702
    • NorthShore University HealthSystem, Skokie, Illinois, 60077
    • Northwestern University, Chicago, Illinois, 60611
  • Alabama

    • University of Alabama at Birmingham, Birmingham, Alabama, 35233
    • Cardio-Thoracic Surgeons, PC, Birmingham, Alabama, 35242
  • Indiana

    • Indiana Spine Group, Carmel, Indiana, 46032
  • Michigan

    • Borgess Research Institute, Kalamazoo, Michigan, 49048
  • Kentucky

    • Bluegrass Orthopedics, Lexington, Kentucky, 40509
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