The Fibrin Pad Cardiovascular Study
- Conditions
- Cardiovascular Disease
- Registration Number
- NCT01681030
- Lead Sponsor
- Ethicon, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application. 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
- Secondary Outcome Measures
Name Time Method Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application Intraoperative, 6 minutes following treatment application The number of subjects achieving hemostatic success at 6 minutes following treatment application.
Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application Intraoperative, 10 minutes following treatment application Number of subjects achieving hemostatic success at 10 minutes following treatment application.
Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment Intra-operative, prior initiation of final chest wall closure. Safety Issue: The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had re-bleeding requiring treatment
Number of Participants With Adverse Events Potentially Related to Thrombotic Events 30 days (+ 14 days) following surgery The number of subjects with an adverse event potentially related to a thrombotic event
Trial Locations
- Locations (6)
Clinical Investigation Site #5
🇺🇸Indianapolis, Indiana, United States
Clinical Investigation Site #6
🇺🇸Kansas City, Missouri, United States
Clinical Investigation Site #4
🇺🇸Camden, New Jersey, United States
Clinical Investigation Site #1
🇺🇸Paterson, New Jersey, United States
Clinical Investigation Site #3
🇺🇸New York, New York, United States
Clinical Investigation Site #2
🇺🇸New York, New York, United States
Clinical Investigation Site #5🇺🇸Indianapolis, Indiana, United States