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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Ethicon, Inc.
- Enrollment
- 156
- Locations
- 24
- Primary Endpoint
- Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
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 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
- •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;
Arms & Interventions
EVARREST™ Fibrin Sealant Patch
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).
Intervention: EVARREST™ Fibrin Sealant Patch (Biological)
Topical hemostat
Equine collagen with Human Fibrinogen and Human Thrombin
Intervention: Topical hemostat (Biological)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application(Intraoperative, 6 minutes following treatment application)
- Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application(Intraoperative, 10 minutes following treatment application)
- Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment(Intra-operative, prior initiation of final chest wall closure.)