Clinical trial NCT01527357: A Study of Fibrocaps™ in Surgical Bleeding
Official title: A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mild or Moderate Surgical Bleeding
Keywords: fibrin sealant
thrombin
fibrinogen
hemostasis
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2012-02-07
Enrollment: 721
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Has signed an institutional review board/independent ethics committee (IRB/IEC)-approved informed consent document
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:

1. Has known antibodies or hypersensitivity to thrombin or other coagulation factors
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)

Primary outcomes:
measure: Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery
timeFrame: Within 5 minutes
measure: Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery
timeFrame: Within 5 minutes
measure: Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection
timeFrame: Within 5 minutes
measure: Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection
timeFrame: Within 5 minutes
Secondary outcomes:
measure: Restricted Mean TTH
timeFrame: Within 5 minutes
measure: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: Within 29 days
measure: Number of Participants Who Require Alternative Hemostatic Agents at 5 Minutes
timeFrame: At 5 minutes
measure: Number of Participants Who Required Red Blood Cells
timeFrame: Within 29 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: Cardio-Thoracic Surgeons, PC
state: Alabama
city: Los Angeles
country: United States
facility: University of Southern California, Keck School of Medicine
state: California
city: Los Angeles
country: United States
facility: University of Southern California/Norris Comprehensive Cancer Center
state: California
city: Orange
country: United States
facility: Vascular Interventional Specialists of Orange County
state: California
city: Pasadena
country: United States
facility: Lotus Clinical Research, LLC
state: California
city: Boulder
country: United States
facility: Boulder Neurological Institute
state: Colorado
city: Durango
country: United States
facility: Spine Colorado
state: Colorado
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Lexington
country: United States
facility: Bluegrass Orthopedics
state: Kentucky
city: Burlington
country: United States
facility: Lahey Clinic Medical Center
state: Massachusetts
city: Kalamazoo
country: United States
facility: Borgess Research Institute
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Health System
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: William Muir MD Spine Surgery
state: Nevada
city: New York
country: United States
facility: New York-Presbyterian Hospital/Columbia University
state: New York
city: Durham
country: United States
facility: Duke University Hospital Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Tulsa
country: United States
facility: The University of Oklahoma - Tulsa
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University Hospital & Clinics
state: Oregon
city: Fort Worth
country: United States
facility: University of North Texas Health Sciences Center
state: Texas
city: Sandy
country: United States
facility: Physician's Research Options
state: Utah
city: Bellevue
country: United States
facility: Overlake Hospital Medical Center
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Spokane
country: United States
facility: Northwest Orthopaedic Specialists, P.S.
state: Washington
city: Tacoma
country: United States
facility: Multicare Neuroscience Center of Washington
state: Washington
city: Brussells
country: Belgium
facility: Militair Hospitaal Koningin Astrid
city: Bruxelles
country: Belgium
facility: Clinique du Parc Leopold, Service de Neurochirurgie
city: Bruxelles
country: Belgium
facility: Hopital Erasme, Service de Neurochirurgie
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent, Gasto-Intestinale Heelkunde
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven, Abdominale Heelkunde
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Velp
country: Netherlands
facility: Rijnstate Arnhem
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital Vascular Department
state: England
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary
state: England
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
state: England
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
state: England
city: London
country: United Kingdom
facility: King's College Hospital
state: England
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
state: England
Study officials:
affiliation: Mallinckrodt
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.