Mild or Moderate Surgical BleedingPhase 3FINISH-3NCT01527357

A Study of Fibrocaps™ in Surgical Bleeding

A Phase 3 study testing Fibrocaps and Gelatin sponge in people with Mild or Moderate Surgical Bleeding, run by Mallinckrodt at 48 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Mild or Moderate Surgical Bleeding
What is being tested?: Fibrocaps and Gelatin sponge
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 721 participants
Where: 48 sitesin 4 countries
Study dates: 21 May 2012to 1 Jun 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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

Who cannot join

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)

Trial locations and contacts

48 sites in 4 countries.

Country

City, postcode or hospital

48 sites in 4 countries

United States29 sites

Overlake Hospital Medical Center
Bellevue, Washington, 98004
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Cardio-Thoracic Surgeons, PC
Birmingham, Alabama, 35242
Boulder Neurological Institute
Boulder, Colorado, 80304
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805
Indiana Spine Group
Carmel, Indiana, 46032
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Spine Colorado
Durango, Colorado, 81303
Duke University Hospital Medical Center
Durham, North Carolina, 27710
University of North Texas Health Sciences Center
Fort Worth, Texas, 76107
Borgess Research Institute
Kalamazoo, Michigan, 49048
William Muir MD Spine Surgery
Las Vegas, Nevada, 89144
Bluegrass Orthopedics
Lexington, Kentucky, 40509
University of Southern California, Keck School of Medicine
Los Angeles, California, 90033
University of Southern California/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
New York-Presbyterian Hospital/Columbia University
New York, New York, 100032
Vascular Interventional Specialists of Orange County
Orange, California, 92868
Lotus Clinical Research, LLC
Pasadena, California, 91105
Oregon Health & Science University Hospital & Clinics
Portland, Oregon, 97239-3098
Beaumont Health System
Royal Oak, Michigan, 48073
Physician's Research Options
Sandy City, Utah, 84070
Virginia Mason Medical Center
Seattle, Washington, 98101
NorthShore University HealthSystem
Skokie, Illinois, 60077
Northwest Orthopaedic Specialists, P.S.
Spokane, Washington, 99208
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Washington University School of Medicine
St Louis, Missouri, 63110
Multicare Neuroscience Center of Washington
Tacoma, Washington, 98405
The University of Oklahoma - Tulsa
Tulsa, Oklahoma, 74135

Other trials in United States

Netherlands7 sites

Amphia Hospital
Breda, 4800
Medisch Spectrum Twente
Enschede, 7513 ER
University Medical Centre Groningen
Groningen, 9700 RB
Leiden University Medical Center
Leiden, 2300 RC
Radboud University Medical Center
Nijmegen, 6525 GA
Erasmus Medical Center
Rotterdam, 3075 EA
Rijnstate Arnhem
Velp, 0

Other trials in Netherlands

United Kingdom7 sites

Queen Elizabeth Hospital Birmingham
Birmingham, England, B15 2WB
Addenbrookes Hospital Vascular Department
Cambridge, England, CB2 0QQ
Doncaster Royal Infirmary
Doncaster, England, DN2 5LT
Hull Royal Infirmary
Hull, England, HU3 2JZ
Leeds General Infirmary
Leeds, England, LS1 3EX
King's College Hospital
London, England, SE5 9RS
Freeman Hospital
Newcastle upon Tyne, England, NE7 7DN

Other trials in United Kingdom

Belgium5 sites

Militair Hospitaal Koningin Astrid
Brussells, 1120
Clinique du Parc Leopold, Service de Neurochirurgie
Brussels, B-1040
Hopital Erasme, Service de Neurochirurgie
Brussels, B-1070
Universitair Ziekenhuis Gent, Gasto-Intestinale Heelkunde
Ghent, 9000
Universitair Ziekenhuis Leuven, Abdominale Heelkunde
Leuven, 3000

Other trials in Belgium

About this study

Official title: 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.

Conditions: Mild or Moderate Surgical Bleeding
Being tested: Fibrocaps, Gelatin sponge
Keywords: fibrin sealant, thrombin, fibrinogen, hemostasis
Medical subject headings: Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FibrocapsBiological
Also called PRO-0601, Fibrin sealant
Human fibrinogen and thrombin powder, for topical administration.
Gelatin spongeBiological
Also called Gelfoam, Spongostan
Absorbable gelatin sponge for topical administration.

Study groups in NCT01527357
Study group	Role	What they receive
Fibrocaps + Gelatin Sponge	Experimental	Single application of Fibrocaps plus gelatin sponge. Receives: Biological: Fibrocaps; Biological: Gelatin sponge
Gelatin Sponge	Active comparator	Single application of gelatin sponge alone. Receives: Biological: Gelatin sponge

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 5 minutes

Secondary outcomes (4)

Restricted Mean TTH
Restricted mean TTH over 5 minutes is computed using Irwin's estimator, based on data collected by surgery type and treatment.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: Within 29 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 May 20121 Jun 2013

First posted7 Feb 2012 (estimated)
Study start21 May 2012
Primary completion24 Apr 2013
Study completion1 Jun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Mild or Moderate Surgical BleedingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 721 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01527357
Sponsor's protocol ID: FC-004
Acronym: FINISH-3
Status last verified: Jul 2016
First submitted: 26 Jan 2012
Last updated: 18 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

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.
PubMed 26254451
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.
PubMed 25458801

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis
ClinicalTrials.gov ID: NCT01527357
Acronym / sponsor ID: FINISH-3 / FC-004
Conditions: Mild or Moderate Surgical Bleeding
Keywords: fibrin sealant, thrombin, fibrinogen, hemostasis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 721 participants (actual)
Lead sponsor: MallinckrodtIndustry (pharma, biotech, devices)
Study start: 21 May 2012 (actual)
Primary completion: 24 Apr 2013 (actual)
Study completion: 1 Jun 2013 (actual)
First posted: 7 Feb 2012 (estimated)
Results: Posted 18 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Fibrocaps + Gelatin Sponge	Experimental	Biological: Fibrocaps, Biological: Gelatin spongeSingle application of Fibrocaps plus gelatin sponge.
Gelatin Sponge	Active comparator	Biological: Gelatin spongeSingle application of gelatin sponge alone.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FibrocapsAlso: PRO-0601, Fibrin sealantHuman fibrinogen and thrombin powder, for topical administration.	Biological	Fibrocaps + Gelatin Sponge
Gelatin spongeAlso: Gelfoam, SpongostanAbsorbable gelatin sponge for topical administration.	Biological	Fibrocaps + Gelatin Sponge, Gelatin Sponge

Primary outcome

Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery
Time frame: Within 5 minutes
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
Time frame: Within 5 minutes
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
Time frame: Within 5 minutes
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
Time frame: Within 5 minutes
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.

4 secondary outcomes

Restricted Mean TTH
Time frame: Within 5 minutes
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: Within 29 days
Number of Participants Who Require Alternative Hemostatic Agents at 5 Minutes
Time frame: At 5 minutes
Number of Participants Who Required Red Blood Cells
Time frame: Within 29 days

Results and safety

Results posted to the registry on 18 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fibrocaps + Gelatin Sponge	482	465
Gelatin Sponge	239	230

Primary outcome: Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery

Time frame: Within 5 minutes. Median (Inter-Quartile Range). Unit: minutes

Measure	Fibrocaps + Gelatin Sponge n = 122	Gelatin Sponge n = 61
Value	1.0 (0.5 to 1.5)	2.5 (1.5 to 4.0)

Fibrocaps + Gelatin Sponge vs Gelatin Sponge: p < 0.0001, Log Rank

Population analysed: Efficacy population consists of all participants who were randomized, received study treatment, and had a TTH assessment. Number analyzed is the number of participants in the efficacy population who receive each type of surgery.

Primary outcome: Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery

Time frame: Within 5 minutes. Median (95% Confidence Interval). Unit: minutes

Measure	Fibrocaps + Gelatin Sponge n = 117	Gelatin Sponge n = 58
Value	2.0 (1.50 to 2.50)	4.0 (3.00 to 5.00)

Fibrocaps + Gelatin Sponge vs Gelatin Sponge: p < 0.0001, Log Rank

Population analysed: Efficacy population

Primary outcome: Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection

Time frame: Within 5 minutes. Median (95% Confidence Interval). Unit: minutes

Measure	Fibrocaps + Gelatin Sponge n = 119	Gelatin Sponge n = 61
Value	1.0 (1.00 to 1.50)	2.0 (1.50 to 2.50)

Fibrocaps + Gelatin Sponge vs Gelatin Sponge: p < 0.0001, Log Rank

Population analysed: Efficacy population

Primary outcome: Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection

Time frame: Within 5 minutes. Median (95% Confidence Interval). Unit: minutes

Measure	Fibrocaps + Gelatin Sponge n = 122	Gelatin Sponge n = 59
Value	1.5 (1.00 to 1.50)	2.5 (2.00 to 3.50)

Fibrocaps + Gelatin Sponge vs Gelatin Sponge: p < 0.0001, Log Rank

Population analysed: Efficacy population

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From time of surgery (Day 1) through Day 29 (End of Study). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fibrocaps + Gelatin Sponge	81 of 480 (16.9%)	426 of 480 (88.8%)	8 of 480
Gelatin Sponge	29 of 239 (12.1%)	214 of 239 (89.5%)	2 of 239

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26254451Gupta 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.
Derived from this study: PubMed 25458801Bochicchio 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Leader study director

Mallinckrodt

48 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fibrocaps and Gelatin sponge in people with Mild or Moderate Surgical Bleeding, run by Mallinckrodt at 48 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Netherlands, United Kingdom, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery (time frame: Within 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01527357, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.