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

Primary Purpose

Mild or Moderate Surgical Bleeding

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fibrocaps
Gelatin sponge
Sponsored by
Mallinckrodt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild or Moderate Surgical Bleeding focused on measuring fibrin sealant, thrombin, fibrinogen, hemostasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Alabama at Birmingham
  • Cardio-Thoracic Surgeons, PC
  • University of Southern California, Keck School of Medicine
  • University of Southern California/Norris Comprehensive Cancer Center
  • Vascular Interventional Specialists of Orange County
  • Lotus Clinical Research, LLC
  • Boulder Neurological Institute
  • Spine Colorado
  • Northwestern University
  • NorthShore University HealthSystem
  • Southern Illinois University School of Medicine
  • Indiana Spine Group
  • Bluegrass Orthopedics
  • Lahey Clinic Medical Center
  • Borgess Research Institute
  • Beaumont Health System
  • Washington University School of Medicine
  • William Muir MD Spine Surgery
  • New York-Presbyterian Hospital/Columbia University
  • Duke University Hospital Medical Center
  • Cleveland Clinic Foundation
  • The University of Oklahoma - Tulsa
  • Oregon Health & Science University Hospital & Clinics
  • University of North Texas Health Sciences Center
  • Physician's Research Options
  • Overlake Hospital Medical Center
  • Virginia Mason Medical Center
  • Northwest Orthopaedic Specialists, P.S.
  • Multicare Neuroscience Center of Washington
  • Militair Hospitaal Koningin Astrid
  • Clinique du Parc Leopold, Service de Neurochirurgie
  • Hopital Erasme, Service de Neurochirurgie
  • Universitair Ziekenhuis Gent, Gasto-Intestinale Heelkunde
  • Universitair Ziekenhuis Leuven, Abdominale Heelkunde
  • Amphia Hospital
  • Medisch Spectrum Twente
  • University Medical Centre Groningen
  • Leiden University Medical Center
  • Radboud University Medical Center
  • Erasmus Medical Center
  • Rijnstate Arnhem
  • Queen Elizabeth Hospital Birmingham
  • Addenbrookes Hospital Vascular Department
  • Doncaster Royal Infirmary
  • Hull Royal Infirmary
  • Leeds General Infirmary
  • King's College Hospital
  • Freeman Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fibrocaps + Gelatin Sponge

Gelatin Sponge

Arm Description

Single application of Fibrocaps plus gelatin sponge.

Single application of gelatin sponge alone.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Restricted Mean TTH
Restricted mean TTH over 5 minutes is computed using Irwin's estimator, based on data collected by surgery type and treatment.
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.
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.
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".

Full Information

First Posted
January 26, 2012
Last Updated
December 5, 2019
Sponsor
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT01527357
Brief Title
A Study of Fibrocaps™ in Surgical Bleeding
Acronym
FINISH-3
Official Title
A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 21, 2012 (Actual)
Primary Completion Date
April 24, 2013 (Actual)
Study Completion Date
June 1, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild or Moderate Surgical Bleeding
Keywords
fibrin sealant, thrombin, fibrinogen, hemostasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
721 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fibrocaps + Gelatin Sponge
Arm Type
Experimental
Arm Description
Single application of Fibrocaps plus gelatin sponge.
Arm Title
Gelatin Sponge
Arm Type
Active Comparator
Arm Description
Single application of gelatin sponge alone.
Intervention Type
Biological
Intervention Name(s)
Fibrocaps
Other Intervention Name(s)
PRO-0601, Fibrin sealant
Intervention Description
Human fibrinogen and thrombin powder, for topical administration.
Intervention Type
Biological
Intervention Name(s)
Gelatin sponge
Other Intervention Name(s)
Gelfoam, Spongostan
Intervention Description
Absorbable gelatin sponge for topical administration.
Primary Outcome Measure Information:
Title
Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery
Description
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 Frame
Within 5 minutes
Title
Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery
Description
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 Frame
Within 5 minutes
Title
Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection
Description
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 Frame
Within 5 minutes
Title
Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection
Description
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 Frame
Within 5 minutes
Secondary Outcome Measure Information:
Title
Restricted Mean TTH
Description
Restricted mean TTH over 5 minutes is computed using Irwin's estimator, based on data collected by surgery type and treatment.
Time Frame
Within 5 minutes
Title
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Description
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.
Time Frame
Within 29 days
Title
Number of Participants Who Require Alternative Hemostatic Agents at 5 Minutes
Description
If hemostasis is not achieved within 5 minutes, the treatment is considered to have failed, and the surgeon is to implement additional hemostatic measures.
Time Frame
At 5 minutes
Title
Number of Participants Who Required Red Blood Cells
Description
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".
Time Frame
Within 29 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Cardio-Thoracic Surgeons, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
University of Southern California, Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Southern California/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Vascular Interventional Specialists of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Lotus Clinical Research, LLC
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Boulder Neurological Institute
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Spine Colorado
City
Durango
State/Province
Colorado
ZIP/Postal Code
81303
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
NorthShore University HealthSystem
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Indiana Spine Group
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Bluegrass Orthopedics
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Lahey Clinic Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Borgess Research Institute
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Beaumont Health System
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
William Muir MD Spine Surgery
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
New York-Presbyterian Hospital/Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
100032
Country
United States
Facility Name
Duke University Hospital Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The University of Oklahoma - Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Oregon Health & Science University Hospital & Clinics
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
University of North Texas Health Sciences Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Physician's Research Options
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Overlake Hospital Medical Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Northwest Orthopaedic Specialists, P.S.
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Multicare Neuroscience Center of Washington
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Militair Hospitaal Koningin Astrid
City
Brussells
ZIP/Postal Code
1120
Country
Belgium
Facility Name
Clinique du Parc Leopold, Service de Neurochirurgie
City
Bruxelles
ZIP/Postal Code
B-1040
Country
Belgium
Facility Name
Hopital Erasme, Service de Neurochirurgie
City
Bruxelles
ZIP/Postal Code
B-1070
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent, Gasto-Intestinale Heelkunde
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven, Abdominale Heelkunde
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Amphia Hospital
City
Breda
ZIP/Postal Code
4800
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7513 ER
Country
Netherlands
Facility Name
University Medical Centre Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Rijnstate Arnhem
City
Velp
ZIP/Postal Code
0
Country
Netherlands
Facility Name
Queen Elizabeth Hospital Birmingham
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2WB
Country
United Kingdom
Facility Name
Addenbrookes Hospital Vascular Department
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Doncaster Royal Infirmary
City
Doncaster
State/Province
England
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
State/Province
England
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
State/Province
England
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
King's College Hospital
City
London
State/Province
England
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle upon Tyne
State/Province
England
ZIP/Postal Code
NE7 7DN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26254451
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.
Results Reference
derived
PubMed Identifier
25458801
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.
Results Reference
derived

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A Study of Fibrocaps™ in Surgical Bleeding

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