The Fibrin Pad Cardiovascular Study

Ethicon

Status and phase: Completed; Phase 2

Conditions: Cardiovascular Disease

Treatments: Other: Standard of Care; Biological: Topical hemostat; Biological: EVARREST™

Study type: Interventional

Funder types: Industry

Identifiers

NCT01681030

400-12-002

Details and patient eligibility

About

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.

Enrollment: 42 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

EVARREST™

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™

Topical hemostat

Active Comparator group

Description:

Equine collagen with Human Fibrinogen and Human Thrombin

Treatment:

Biological: Topical hemostat

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Other: Standard of Care