Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
721 participants
INTERVENTIONAL
2012-05-21
2013-06-01
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Fibrocaps + Gelatin Sponge
Single application of Fibrocaps plus gelatin sponge.
Fibrocaps
Human fibrinogen and thrombin powder, for topical administration.
Gelatin sponge
Absorbable gelatin sponge for topical administration.
Gelatin Sponge
Single application of gelatin sponge alone.
Gelatin sponge
Absorbable gelatin sponge for topical administration.
Interventions
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Fibrocaps
Human fibrinogen and thrombin powder, for topical administration.
Gelatin sponge
Absorbable gelatin sponge for topical administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Is undergoing one of the 4 surgical procedures described
3. Is at least 18 years old at time of consent
4. If female and of child-bearing potential, has negative pregnancy test during screening and is not breast-feeding
5. 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
6. Has not received blood transfusion between screening and study treatment
7. Has mild to moderate surgical bleeding
8. Does not have intra-operative complications
9. Has not used a topical hemostat containing thrombin prior to study treatment
10. Has an approximate bleeding site surface area of less than or equal to 100 cm\^2
Exclusion Criteria
2. Has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required)
3. Has known allergy to gelatin sponge
4. Is unwilling to receive blood products
5. Has liver enzymes appropriate for the study, considering their disease
6. Has appropriate level of platelets per liter (PLT/L) during screening
7. 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)
18 Years
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Cardio-Thoracic Surgeons, PC
Birmingham, Alabama, United States
University of Southern California, Keck School of Medicine
Los Angeles, California, 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
Bluegrass Orthopedics
Lexington, Kentucky, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, United States
Borgess Research Institute
Kalamazoo, Michigan, United States
Beaumont Health System
Royal Oak, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
William Muir MD Spine Surgery
Las Vegas, Nevada, United States
New York-Presbyterian Hospital/Columbia University
New York, New York, United States
Duke University Hospital Medical Center
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The University of Oklahoma - Tulsa
Tulsa, Oklahoma, United States
Oregon Health & Science University Hospital & Clinics
Portland, Oregon, United States
University of North Texas Health Sciences Center
Fort Worth, Texas, United States
Physician's Research Options
Sandy City, Utah, United States
Overlake Hospital Medical Center
Bellevue, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Northwest Orthopaedic Specialists, P.S.
Spokane, Washington, United States
Multicare Neuroscience Center of Washington
Tacoma, Washington, United States
Militair Hospitaal Koningin Astrid
Brussells, , Belgium
Clinique du Parc Leopold, Service de Neurochirurgie
Brussels, , Belgium
Hopital Erasme, Service de Neurochirurgie
Brussels, , Belgium
Universitair Ziekenhuis Gent, Gasto-Intestinale Heelkunde
Ghent, , Belgium
Universitair Ziekenhuis Leuven, Abdominale Heelkunde
Leuven, , Belgium
Amphia Hospital
Breda, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
University Medical Centre Groningen
Groningen, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Radboud University Medical Center
Nijmegen, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Rijnstate Arnhem
Velp, , Netherlands
Queen Elizabeth Hospital Birmingham
Birmingham, England, United Kingdom
Addenbrookes Hospital Vascular Department
Cambridge, England, United Kingdom
Doncaster Royal Infirmary
Doncaster, England, United Kingdom
Hull Royal Infirmary
Hull, England, United Kingdom
Leeds General Infirmary
Leeds, England, United Kingdom
King's College Hospital
London, England, United Kingdom
Freeman Hospital
Newcastle upon Tyne, England, United Kingdom
Countries
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References
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Gupta N, Chetter I, Hayes P, O-Yurvati AH, Moneta GL, Shenoy S, Pribble JP, Zuckerman LA. Randomized trial of a dry-powder, fibrin sealant in vascular procedures. J Vasc Surg. 2015 Nov;62(5):1288-95. doi: 10.1016/j.jvs.2015.05.038. Epub 2015 Aug 5.
Bochicchio GV, Gupta N, Porte RJ, Renkens KL, Pattyn P, Topal B, Troisi RI, Muir W, Chetter I, Gillen DL, Zuckerman LA, Frohna PA. The FINISH-3 trial: a phase 3, international, randomized, single-blind, controlled trial of topical fibrocaps in intraoperative surgical hemostasis. J Am Coll Surg. 2015 Jan;220(1):70-81. doi: 10.1016/j.jamcollsurg.2014.09.019. Epub 2014 Oct 13.
Other Identifiers
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FC-004
Identifier Type: -
Identifier Source: org_study_id