A Study of Fibrocaps™ in Surgical Bleeding
FINISH-3
A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis
1 other identifier
interventional
721
4 countries
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2012
Shorter than P25 for phase_3
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2012
CompletedFirst Posted
Study publicly available on registry
February 7, 2012
CompletedStudy Start
First participant enrolled
May 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
December 18, 2019
CompletedDecember 18, 2019
July 1, 2016
11 months
January 26, 2012
December 5, 2019
December 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery
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.
Within 5 minutes
Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery
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.
Within 5 minutes
Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection
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.
Within 5 minutes
Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection
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.
Within 5 minutes
Secondary Outcomes (4)
Restricted Mean TTH
Within 5 minutes
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Within 29 days
Number of Participants Who Require Alternative Hemostatic Agents at 5 Minutes
At 5 minutes
Number of Participants Who Required Red Blood Cells
Within 29 days
Study Arms (2)
Fibrocaps + Gelatin Sponge
EXPERIMENTALSingle application of Fibrocaps plus gelatin sponge.
Gelatin Sponge
ACTIVE COMPARATORSingle application of gelatin sponge alone.
Interventions
Human fibrinogen and thrombin powder, for topical administration.
Absorbable gelatin sponge for topical administration.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mallinckrodtlead
Study Sites (48)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Cardio-Thoracic Surgeons, PC
Birmingham, Alabama, 35242, United States
University of Southern California, Keck School of Medicine
Los Angeles, California, 90033, United States
University of Southern California/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Vascular Interventional Specialists of Orange County
Orange, California, 92868, United States
Lotus Clinical Research, LLC
Pasadena, California, 91105, United States
Boulder Neurological Institute
Boulder, Colorado, 80304, United States
Spine Colorado
Durango, Colorado, 81303, United States
Northwestern University
Chicago, Illinois, 60611, United States
NorthShore University HealthSystem
Skokie, Illinois, 60077, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Indiana Spine Group
Carmel, Indiana, 46032, United States
Bluegrass Orthopedics
Lexington, Kentucky, 40509, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805, United States
Borgess Research Institute
Kalamazoo, Michigan, 49048, United States
Beaumont Health System
Royal Oak, Michigan, 48073, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
William Muir MD Spine Surgery
Las Vegas, Nevada, 89144, United States
New York-Presbyterian Hospital/Columbia University
New York, New York, 100032, United States
Duke University Hospital Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The University of Oklahoma - Tulsa
Tulsa, Oklahoma, 74135, United States
Oregon Health & Science University Hospital & Clinics
Portland, Oregon, 97239-3098, United States
University of North Texas Health Sciences Center
Fort Worth, Texas, 76107, United States
Physician's Research Options
Sandy City, Utah, 84070, United States
Overlake Hospital Medical Center
Bellevue, Washington, 98004, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Northwest Orthopaedic Specialists, P.S.
Spokane, Washington, 99208, United States
Multicare Neuroscience Center of Washington
Tacoma, Washington, 98405, United States
Militair Hospitaal Koningin Astrid
Brussells, 1120, Belgium
Clinique du Parc Leopold, Service de Neurochirurgie
Brussels, B-1040, Belgium
Hopital Erasme, Service de Neurochirurgie
Brussels, B-1070, Belgium
Universitair Ziekenhuis Gent, Gasto-Intestinale Heelkunde
Ghent, 9000, Belgium
Universitair Ziekenhuis Leuven, Abdominale Heelkunde
Leuven, 3000, Belgium
Amphia Hospital
Breda, 4800, Netherlands
Medisch Spectrum Twente
Enschede, 7513 ER, Netherlands
University Medical Centre Groningen
Groningen, 9700 RB, Netherlands
Leiden University Medical Center
Leiden, 2300 RC, Netherlands
Radboud University Medical Center
Nijmegen, 6525 GA, Netherlands
Erasmus Medical Center
Rotterdam, 3075 EA, Netherlands
Rijnstate Arnhem
Velp, 0, Netherlands
Queen Elizabeth Hospital Birmingham
Birmingham, England, B15 2WB, United Kingdom
Addenbrookes Hospital Vascular Department
Cambridge, England, CB2 0QQ, United Kingdom
Doncaster Royal Infirmary
Doncaster, England, DN2 5LT, United Kingdom
Hull Royal Infirmary
Hull, England, HU3 2JZ, United Kingdom
Leeds General Infirmary
Leeds, England, LS1 3EX, United Kingdom
King's College Hospital
London, England, SE5 9RS, United Kingdom
Freeman Hospital
Newcastle upon Tyne, England, NE7 7DN, United Kingdom
Related Publications (2)
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.
PMID: 26254451DERIVEDBochicchio 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.
PMID: 25458801DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information Call Center
- Organization
- Mallinckrodt Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Mallinckrodt
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2012
First Posted
February 7, 2012
Study Start
May 21, 2012
Primary Completion
April 24, 2013
Study Completion
June 1, 2013
Last Updated
December 18, 2019
Results First Posted
December 18, 2019
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share