The Fibrin Pad Cardiovascular Study
This study is currently recruiting participants.
Verified April 2013 by Ethicon, Inc.
Sponsor:
Ethicon, Inc.
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT01681030
First received: September 5, 2012
Last updated: April 1, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disease |
Biological: EVARREST™ Biological: Topical hemostat Other: Standard of Care |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Ethicon, Inc.:
Primary Outcome Measures:
- Hemostasis at the Target Bleeding Site (TBS) at 3-minutes following treatment application [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]Hemostasis at the TBS at 3-minutes following treatment application and with no re-bleeding requiring treatment at the TBS any time prior to initiation of final chest wall closure. Hemostasis is defined as no detectable bleeding at the TBS.
| Estimated Enrollment: | 45 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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™
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).
|
|
Active Comparator: Topical hemostat
Equine collagen with Human Fibrinogen and Human Thrombin
|
Biological: Topical hemostat
Equine collagen with Human Fibrinogen and Human Thrombin
|
|
Active Comparator: Standard of Care
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.
|
Other: Standard of Care
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681030
Contacts
| Contact: Jonathan Batiller | 908-218-2492 | jbatill2@its.jnj.com |
Locations
| United States, Indiana | |
| Clinical Investigation Site #5 | Recruiting |
| Indianopolis, Indiana, United States, 46260 | |
| United States, Missouri | |
| Clinical Investigation Site #6 | Recruiting |
| Kansas City, Missouri, United States, 64111 | |
| United States, New Jersey | |
| Clinical Investigation Site #4 | Recruiting |
| Camden, New Jersey, United States, 08103 | |
| Clinical Investigation Site #1 | Recruiting |
| Paterson, New Jersey, United States, 07503 | |
| United States, New York | |
| Clinical Investigation Site #3 | Recruiting |
| New York, New York, United States, 10016 | |
| Clinical Investigation Site #2 | Recruiting |
| New York, New York, United States, 10075 | |
Sponsors and Collaborators
Ethicon, Inc.
Investigators
| Study Director: | Jerome Riebman, MD | Ethicon, Inc. |
More Information
No publications provided
| Responsible Party: | Ethicon, Inc. |
| ClinicalTrials.gov Identifier: | NCT01681030 History of Changes |
| Other Study ID Numbers: | 400-12-002 |
| Study First Received: | September 5, 2012 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Fibrin Tissue Adhesive Hemostatics Coagulants |
Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013