A Study of Fibrocaps™ in Surgical Bleeding (FINISH-3)

A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis

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.

Study Overview

• Status: Completed
• Conditions: Mild or Moderate Surgical Bleeding
• Intervention / Treatment: Biological: Fibrocaps; Biological: Gelatin sponge

• Study Type: Interventional
• Enrollment (Actual): 721
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussells, Belgium, 1120
    • Militair Hospitaal Koningin Astrid
  • Bruxelles, Belgium, B-1040
    • Clinique du Parc Leopold, Service de Neurochirurgie
  • Bruxelles, Belgium, B-1070
    • Hopital Erasme, Service de Neurochirurgie
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent, Gasto-Intestinale Heelkunde
  • Leuven, Belgium, 3000
    • Universitair Ziekenhuis Leuven, Abdominale Heelkunde
• Netherlands
  • Breda, Netherlands, 4800
    • Amphia Hospital
  • Enschede, Netherlands, 7513 ER
    • Medisch Spectrum Twente
  • Groningen, Netherlands, 9700 RB
    • University Medical Centre Groningen
  • Leiden, Netherlands, 2300 RC
    • Leiden University Medical Center
  • Nijmegen, Netherlands, 6525 GA
    • Radboud University Medical Center
  • Rotterdam, Netherlands, 3075 EA
    • Erasmus Medical Center
  • Velp, Netherlands
    • Rijnstate Arnhem
• United Kingdom
  • England
    • Birmingham, England, United Kingdom, B15 2WB
      • Queen Elizabeth Hospital Birmingham
    • Cambridge, England, United Kingdom, CB2 0QQ
      • Addenbrookes Hospital Vascular Department
    • Doncaster, England, United Kingdom, DN2 5LT
      • Doncaster Royal Infirmary
    • Hull, England, United Kingdom, HU3 2JZ
      • Hull Royal Infirmary
    • Leeds, England, United Kingdom, LS1 3EX
      • Leeds General Infirmary
    • London, England, United Kingdom, SE5 9RS
      • King's College Hospital
    • Newcastle upon Tyne, England, United Kingdom, NE7 7DN
      • Freeman Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35242
      • Cardio-Thoracic Surgeons, PC
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California, Keck School of Medicine
    • Los Angeles, California, United States, 90033
      • University of Southern California/Norris Comprehensive Cancer Center
    • Orange, California, United States, 92868
      • Vascular Interventional Specialists of Orange County
    • Pasadena, California, United States, 91105
      • Lotus Clinical Research, LLC
  • Colorado
    • Boulder, Colorado, United States, 80304
      • Boulder Neurological Institute
    • Durango, Colorado, United States, 81303
      • Spine Colorado
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Skokie, Illinois, United States, 60077
      • NorthShore University HealthSystem
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University School of Medicine
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Indiana Spine Group
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Bluegrass Orthopedics
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic Medical Center
  • Michigan
    • Kalamazoo, Michigan, United States, 49048
      • Borgess Research Institute
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Health System
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • William Muir MD Spine Surgery
  • New York
    • New York, New York, United States, 100032
      • New York-Presbyterian Hospital/Columbia University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74135
      • The University of Oklahoma - Tulsa
  • Oregon
    • Portland, Oregon, United States, 97239-3098
      • Oregon Health & Science University Hospital & Clinics
  • Texas
    • Fort Worth, Texas, United States, 76107
      • University of North Texas Health Sciences Center
  • Utah
    • Sandy, Utah, United States, 84070
      • Physician's Research Options
  • Washington
    • Bellevue, Washington, United States, 98004
      • Overlake Hospital Medical Center
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Spokane, Washington, United States, 99208
      • Northwest Orthopaedic Specialists, P.S.
    • Tacoma, Washington, United States, 98405
      • Multicare Neuroscience Center of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fibrocaps + Gelatin Sponge; Single application of Fibrocaps plus gelatin sponge.	Biological: Fibrocaps; Human fibrinogen and thrombin powder, for topical administration.; Other Names: Fibrin sealant; PRO-0601; Biological: Gelatin sponge; Absorbable gelatin sponge for topical administration.; Other Names: Gelfoam; Spongostan
Active Comparator: Gelatin Sponge; Single application of gelatin sponge alone.	Biological: Gelatin sponge; Absorbable gelatin sponge for topical administration.; Other Names: Gelfoam; Spongostan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restricted Mean TTH	Restricted mean TTH over 5 minutes is computed using Irwin's estimator, based on data collected by surgery type and treatment.	Within 5 minutes
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)	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.	Within 29 days
Number of Participants Who Require Alternative Hemostatic Agents 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.	At 5 minutes
Number of Participants Who Required Red Blood Cells	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".	Within 29 days

Collaborators and Investigators

• Sponsor: Mallinckrodt

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2012
• Primary Completion (Actual): April 24, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: January 26, 2012
• First Submitted That Met QC Criteria: February 6, 2012
• First Posted (Estimate): February 7, 2012

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: hemostasis; fibrinogen; fibrin sealant; thrombin
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Hemostatics; Coagulants; Fibrin Tissue Adhesive; Fibrin Foam
• Other Study ID Numbers: FC-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO