Cardiovascular DiseasePhase 2NCT01681030
The Fibrin Pad Cardiovascular Study
A Phase 2 study testing EVARREST™ and Topical hemostat in people with Cardiovascular Disease, run by Ethicon, Inc. at 6 sites in United States.
Trial summary
This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in 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™ and Topical hemostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Aug 2012to 3 Sep 2013
- Phase
- Phase 2
- 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 must be willing to participate in the study and provide written informed consent.
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 30 day follow up period after surgery.
- Female subjects who are pregnant or nursing.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Clinical Investigation Site #4
Camden, New Jersey, 08103
Clinical Investigation Site #5
Indianapolis, Indiana, 46260
Clinical Investigation Site #6
Kansas City, Missouri, 64111
Clinical Investigation Site #3
New York, New York, 10016
Clinical Investigation Site #2
New York, New York, 10075
Clinical Investigation Site #1
Paterson, New Jersey, 07503
About this study
Official title: A Randomized, Controlled, Comparative Phase II Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery
This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.
- Conditions
- Cardiovascular Disease
- Being tested
- EVARREST™, Topical hemostat, Standard of Care
- 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™Biological
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).
Topical hemostatBiological
Equine collagen with Human Fibrinogen and Human Thrombin
Standard of CareOther
SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
| Study group | Role | What they receive |
|---|---|---|
| EVARREST™ | 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™ |
| Topical hemostat | Active comparator | Equine collagen with Human Fibrinogen and Human Thrombin Receives: Biological: Topical hemostat |
| Standard of Care | Active comparator | SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 closur
Measured: Intraoperative, 3 minutes following treatment application
Secondary outcomes (4)
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.
Measured: Intraoperative, 6 minutes following treatment application
Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application
Number of subjects achieving hemostatic success at 10 minutes following treatment application.
Measured: Intraoperative, 10 minutes following treatment application
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 re-bleeding requiring treatment
Measured: Intra-operative, prior initiation of final chest wall closure. Safety Issue:
Number of Participants With Adverse Events Potentially Related to Thrombotic Events
The number of subjects with an adverse event potentially related to a thrombotic event
Measured: 30 days (+ 14 days) following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study start1 Aug 2012
- Primary completion1 Aug 2013
- Study completion3 Sep 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerome Riebman, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681030
- Sponsor's protocol ID
- 400-12-002
- Status last verified
- May 2018
- First submitted
- 5 Sep 2012
- Last updated
- 12 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Comparative Phase II Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT01681030
- Acronym / sponsor ID
- 400-12-002
- Conditions
- Cardiovascular Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 1 Aug 2013 (actual)
- Study completion
- 3 Sep 2013 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Posted 7 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EVARREST™ | Experimental | Biological: EVARREST™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). |
| Topical hemostat | Active comparator | Biological: Topical hemostatEquine collagen with Human Fibrinogen and Human Thrombin |
| Standard of Care | Active comparator | Other: Standard of CareSoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass;
- Subjects must be willing to participate in the study and provide written informed consent.
Key exclusion criteria (3 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 30 day follow up period after surgery.
- Female subjects who are pregnant or nursing.
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™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). | Biological | EVARREST™ |
| Topical hemostatEquine collagen with Human Fibrinogen and Human Thrombin | Biological | Topical hemostat |
| Standard of CareSoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. | Other | Standard of Care |
Primary outcome
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 closur
4 secondary outcomes
Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application
Time frame: Intraoperative, 6 minutes following treatment application
Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application
Time frame: Intraoperative, 10 minutes following treatment application
Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment
Time frame: Intra-operative, prior initiation of final chest wall closure. Safety Issue:
Number of Participants With Adverse Events Potentially Related to Thrombotic Events
Time frame: 30 days (+ 14 days) following surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jerome Riebman, MD study director
Ethicon, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EVARREST™ and Topical hemostat in people with Cardiovascular Disease, run by Ethicon, Inc. at 6 sites in United States.
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 2 inclusion and 3 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 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 7 Mar 2018). 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?
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 12 Jun 2018.