Cardiovascular DiseasePhase 3NCT02040428
The Fibrin Pad CV Phase III Study
A Phase 3 study testing EVARREST™ Fibrin Sealant Patch and Topical hemostat in people with Cardiovascular Disease, run by Ethicon, Inc. at 24 sites in 5 countries.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- EVARREST™ Fibrin Sealant Patch and Topical hemostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 24 sitesin 5 countries
- Study dates
- 1 Jan 2014to 1 Sep 2015
- 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
- Subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass. Subjects in Japan between ≥18 and <20 years of age will require consent by the subject's legal representative
- Subjects must be willing to participate in the study and provide written informed consent.
- Presence of an appropriate Target Bleeding Site (TBS) along the anastomotic suture line, involving a synthetic aortic graft, as identified intra-operatively by the investigator;
Who cannot join
- Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
- Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 60 day follow up period after surgery.
- Female subjects who are pregnant or nursing.
- TBS is from a large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST™ Fibrin Sealant Patch to blood flow and/or pressure during absorption of the product;
- TBS with major arterial bleeding requiring suture or mechanical ligation;
- TBS involves an expanded polytetrafluoroethylene (ePTFE) graft
Show all 9Show fewer
- TBS within an actively infected field;
- Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
- Subjects with any intra-operative findings identified by the investigator that may preclude conduct of the study procedure;
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
United States9 sites
Clinical Investigation Site #15
Atlanta, Georgia, 30342
Clinical Investigation Site #16
Baltimore, Maryland, 21201
Clinical Investigation Site #21
Bethesda, Maryland, 20814
Clinical Investigation Site #18
Houston, Texas, 77030
Clinical Investigation Site #14
Indianapolis, Indiana, 46290
Clinical Investigation Site #12
New York, New York, 10016
Clinical Investigation Site #10
Paterson, New Jersey, 07503
Clinical Investigation Site #20
Philadelphia, Pennsylvania, 19102
Clinical Investigation Site #17
St Louis, Missouri, 63110
United Kingdom6 sites
Clinical Investigation Site #32
Aberdeen, Scotland, AB25 2ZN
Clinical Investigation Site #33
Bristol, England, BS2 8HW
Clinical Investigation Site #31
Clydebank, Scotland, G81 4DY
Clinical Investigation Site #35
Cottingham, England, HU16 5JQ
Clinical Investigation Site #30
Edinburgh, Scotland, EH16 4SA
Clinical Investigation Site #34
Manchester, England, M13 9WL
Australia5 sites
Clinical Investigation Site #74
Bedford Park, South Australia, 5042
Clinical Investigation Site #71
Brisbane, Queensland, 4000
Clinical Investigation Site #72
Camperdown, New South Wales, 2050
Clinical Investigation Site #70
Melbourne, Victoria, 3050
Clinical Investigation Site #73
Sydney, New South Wales, 2010
Japan3 sites
Clinical Investigation Site #82
Kanagawa, Isehara-shi
Clinical Investigation Site #80
Osaka, Suita-shi
Clinical Investigation Site #81
Saitama, Saitama-shi
About this study
Official title: A Single-blinded, Randomized, Controlled, Comparative Phase III Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery
The objective of this study is to evaluate the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.
- Conditions
- Cardiovascular Disease
- Being tested
- EVARREST™ Fibrin Sealant Patch, Topical hemostat
- Keywords
- Cardiovascular Diseases, Fibrin Sealant, Hemostatics, Coagulants
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVARREST™ Fibrin Sealant PatchBiological
Topical hemostatBiological
| Study group | Role | What they receive |
|---|---|---|
| EVARREST™ Fibrin Sealant Patch | Experimental | EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). Receives: Biological: EVARREST™ Fibrin Sealant Patch |
| Topical hemostat | Active comparator | Equine collagen with Human Fibrinogen and Human Thrombin Receives: Biological: Topical hemostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.
Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure
Measured: Intraoperative, 3 minutes following treatment application
Secondary outcomes (3)
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application
The number of subjects achieving hemostatic success at 6 minutes following treatment application with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.
Measured: Intraoperative, 6 minutes following treatment application
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application
The number of subjects achieving hemostatic success at 10 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.
Measured: Intraoperative, 10 minutes following treatment application
Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment
The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had intra-operative re-bleeding requiring treatment at the TBS
Measured: Intra-operative, prior initiation of final chest wall closure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study start1 Jan 2014
- Primary completion1 Jul 2015
- Study completion1 Sep 2015
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.
- Other trials for Cardiovascular DiseaseStudies 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
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Kocharian, MD, PhD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040428
- Sponsor's protocol ID
- BIOS-13-004
- Other IDs
- 2013-003464-31
- Status last verified
- Aug 2017
- First submitted
- 17 Jan 2014
- Last updated
- 15 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blinded, Randomized, Controlled, Comparative Phase III Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT02040428
- Acronym / sponsor ID
- BIOS-13-004
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular Diseases, Fibrin Sealant, Hemostatics, Coagulants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Posted 15 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVARREST™ Fibrin Sealant Patch | Experimental | Biological: EVARREST™ Fibrin Sealant PatchEVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). |
| Topical hemostat | Active comparator | Biological: Topical hemostatEquine collagen with Human Fibrinogen and Human Thrombin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass. Subjects in Japan between ≥18 and <20 years of age will require consent by the subject's legal representative
- Subjects must be willing to participate in the study and provide written informed consent.
- Presence of an appropriate Target Bleeding Site (TBS) along the anastomotic suture line, involving a synthetic aortic graft, as identified intra-operatively by the investigator;
Key exclusion criteria (9 listed)
- Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
- Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 60 day follow up period after surgery.
- Female subjects who are pregnant or nursing.
- TBS is from a large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST™ Fibrin Sealant Patch to blood flow and/or pressure during absorption of the product;
- TBS with major arterial bleeding requiring suture or mechanical ligation;
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 |
|---|---|---|
| EVARREST™ Fibrin Sealant Patch | Biological | EVARREST™ Fibrin Sealant Patch |
| Topical hemostat | Biological | Topical hemostat |
Primary outcome
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.
Time frame: Intraoperative, 3 minutes following treatment application
Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure
3 secondary outcomes
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application
Time frame: Intraoperative, 6 minutes following treatment application
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application
Time frame: Intraoperative, 10 minutes following treatment application
Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment
Time frame: Intra-operative, prior initiation of final chest wall closure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Richard Kocharian, MD, PhD study director
Ethicon, Inc.
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EVARREST™ Fibrin Sealant Patch and Topical hemostat in people with Cardiovascular Disease, run by Ethicon, Inc. at 24 sites in 5 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 3 inclusion and 9 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 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, United Kingdom, Australia, Japan, 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 15 Aug 2017). 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?
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application. (time frame: Intraoperative, 3 minutes following treatment application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2017.