A Study of Fibrocaps™ in Surgical Bleeding
- Conditions
- Mild or Moderate Surgical Bleeding
- Interventions
- Biological: Gelatin spongeBiological: Fibrocaps
- Registration Number
- NCT01527357
- Lead Sponsor
- Mallinckrodt
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 721
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gelatin Sponge Gelatin sponge Single application of gelatin sponge alone. Fibrocaps + Gelatin Sponge Fibrocaps Single application of Fibrocaps plus gelatin sponge. Fibrocaps + Gelatin Sponge Gelatin sponge Single application of Fibrocaps plus gelatin sponge.
- Primary Outcome Measures
Name Time Method Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery Within 5 minutes The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.
Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection Within 5 minutes The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.
Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery Within 5 minutes The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.
Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection Within 5 minutes The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Required Red Blood Cells Within 29 days Red blood cells are defined as including World Health Organization (WHO) DRUG terms of "Blood cells, packed human", "Blood, whole", "Red blood cells", "Red blood cells, concentrated" and "Red blood cells, leucocyte depleted".
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) Within 29 days An adverse event (AE) is any untoward medical occurrence (including clinically significant changes in laboratory values or other clinical tests) experienced by a participant administered a pharmaceutical product regardless of causal relationship with the treatment. A TEAE is any adverse event reported on the case report form that occurs after start of treatment or any adverse event with a missing start date.
Restricted Mean TTH Within 5 minutes Restricted mean TTH over 5 minutes is computed using Irwin's estimator, based on data collected by surgery type and treatment.
Number of Participants Who Require Alternative Hemostatic Agents at 5 Minutes At 5 minutes If hemostasis is not achieved within 5 minutes, the treatment is considered to have failed, and the surgeon is to implement additional hemostatic measures.
Trial Locations
- Locations (48)
University of Southern California, Keck School of Medicine
🇺🇸Los Angeles, California, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
University of Southern California/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Vascular Interventional Specialists of Orange County
🇺🇸Orange, California, United States
Lotus Clinical Research, LLC
🇺🇸Pasadena, California, United States
Boulder Neurological Institute
🇺🇸Boulder, Colorado, United States
Spine Colorado
🇺🇸Durango, Colorado, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
NorthShore University HealthSystem
🇺🇸Skokie, Illinois, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Indiana Spine Group
🇺🇸Carmel, Indiana, United States
Borgess Research Institute
🇺🇸Kalamazoo, Michigan, United States
Bluegrass Orthopedics
🇺🇸Lexington, Kentucky, United States
Lahey Clinic Medical Center
🇺🇸Burlington, Massachusetts, United States
Beaumont Health System
🇺🇸Royal Oak, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
New York-Presbyterian Hospital/Columbia University
🇺🇸New York, New York, United States
The University of Oklahoma - Tulsa
🇺🇸Tulsa, Oklahoma, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Physician's Research Options
🇺🇸Sandy, Utah, United States
University of North Texas Health Sciences Center
🇺🇸Fort Worth, Texas, United States
Northwest Orthopaedic Specialists, P.S.
🇺🇸Spokane, Washington, United States
Overlake Hospital Medical Center
🇺🇸Bellevue, Washington, United States
Militair Hospitaal Koningin Astrid
🇧🇪Brussells, Belgium
Multicare Neuroscience Center of Washington
🇺🇸Tacoma, Washington, United States
Clinique du Parc Leopold, Service de Neurochirurgie
🇧🇪Bruxelles, Belgium
Universitair Ziekenhuis Gent, Gasto-Intestinale Heelkunde
🇧🇪Gent, Belgium
Amphia Hospital
🇳🇱Breda, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
University Medical Centre Groningen
🇳🇱Groningen, Netherlands
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Radboud University Medical Center
🇳🇱Nijmegen, Netherlands
Hull Royal Infirmary
🇬🇧Hull, England, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, England, United Kingdom
King's College Hospital
🇬🇧London, England, United Kingdom
Universitair Ziekenhuis Leuven, Abdominale Heelkunde
🇧🇪Leuven, Belgium
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Duke University Hospital Medical Center
🇺🇸Durham, North Carolina, United States
Cardio-Thoracic Surgeons, PC
🇺🇸Birmingham, Alabama, United States
William Muir MD Spine Surgery
🇺🇸Las Vegas, Nevada, United States
Oregon Health & Science University Hospital & Clinics
🇺🇸Portland, Oregon, United States
Addenbrookes Hospital Vascular Department
🇬🇧Cambridge, England, United Kingdom
Queen Elizabeth Hospital Birmingham
🇬🇧Birmingham, England, United Kingdom
Hopital Erasme, Service de Neurochirurgie
🇧🇪Bruxelles, Belgium
Rijnstate Arnhem
🇳🇱Velp, Netherlands
Doncaster Royal Infirmary
🇬🇧Doncaster, England, United Kingdom
Freeman Hospital
🇬🇧Newcastle upon Tyne, England, United Kingdom