The Fibrin Pad CV Phase III Study

Ethicon

Status and phase: Completed; Phase 3

Conditions: Cardiovascular Disease

Treatments: Biological: EVARREST™ Fibrin Sealant Patch; Biological: Topical hemostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT02040428

BIOS-13-004

2013-003464-31 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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156 participants in 2 patient groups

EVARREST™ Fibrin Sealant Patch

Experimental group

Description:

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).

Treatment:

Biological: EVARREST™ Fibrin Sealant Patch

Topical hemostat

Active Comparator group

Description:

Equine collagen with Human Fibrinogen and Human Thrombin

Treatment:

Biological: Topical hemostat