A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis
Description
Brief Summary
The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as
compared to gelatin sponge alone, for achieving hemostasis.
The investigational products were used in participants with mild to moderate surgical
bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to
moderate bleeding by standard surgical techniques is ineffective and/or impractical.
Phase
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
- Has signed an institutional review board/independent ethics committee (IRB/IEC)-approved informed consent document
- Is undergoing one of the 4 surgical procedures described
- Is at least 18 years old at time of consent
- If female and of child-bearing potential, has negative pregnancy test during screening and is not breast-feeding
- If able to reproduce, agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits when engaging in heterosexual intercourse
- Has not received blood transfusion between screening and study treatment
- Has mild to moderate surgical bleeding
- Does not have intra-operative complications
- Has not used a topical hemostat containing thrombin prior to study treatment
- Has an approximate bleeding site surface area of less than or equal to 100 cm^2
- Has known antibodies or hypersensitivity to thrombin or other coagulation factors
- Has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required)
- Has known allergy to gelatin sponge
- Is unwilling to receive blood products
- Has liver enzymes appropriate for the study, considering their disease
- Has appropriate level of platelets per liter (PLT/L) during screening
- 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 during screening that are not explained by current drug treatment (e.g., warfarin, heparin)
Sites
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California
- University of Southern California/Norris Comprehensive Cancer Center, Los Angeles, California, 90033
- University of Southern California, Keck School of Medicine, Los Angeles, California, 90033
- Lotus Clinical Research, LLC, Pasadna, California, 91105
- Vascular Interventional Specialists of Orange County, Orange, California, 92868
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Nevada
- William Muir MD Spine Surgery, Las Vegas, Nevada, 89144
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Utah
- Physician's Research Options, Sandy, Utah, 84070
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Colorado
- Spine Colorado, Durango, Colorado, 81303
- Boulder Neurological Institute, Boulder, Colorado, 80304
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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
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Texas
- University of North Texas Health Sciences Center, Fort Worth, Texas, 76107
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Oklahoma
- The University of Oklahoma - Tulsa, Tulsa, Oklahoma, 74135
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Missouri
- Washington University School of Medicine, St. Louis, Missouri, 63110
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Illinois
- Southern Illinois University School of Medicine, Springfield, Illinois, 62702
- NorthShore University HealthSystem, Skokie, Illinois, 60077
- Northwestern University, Chicago, Illinois, 60611
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Alabama
- University of Alabama at Birmingham, Birmingham, Alabama, 35233
- Cardio-Thoracic Surgeons, PC, Birmingham, Alabama, 35242
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Indiana
- Indiana Spine Group, Carmel, Indiana, 46032
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Michigan
- Borgess Research Institute, Kalamazoo, Michigan, 49048
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Kentucky
- Bluegrass Orthopedics, Lexington, Kentucky, 40509
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