The EVARREST® Fibrin Sealant Patch Liver Study

Ethicon

Status and phase: Completed; Phase 3

Conditions: Hemorrhage

Treatments: Biological: EVARREST® Fibrin Sealant Patch; Other: Standard of Care (SoC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01993888

2013-002535-24 (EudraCT Number)

BIOS-13-005

Details and patient eligibility

About

To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects ≥ 18 years of age, requiring elective or urgent, open hepatic surgery.
• Presence of an appropriate bleeding hepatic parenchymal Target Bleeding Site (TBS) as identified intra-operatively by the surgeon
• Subjects or legally authorized representatives must be willing to participate in the study, and provide written informed consent. (Note: This criteria does allow for hospital translators to be used where approved by Ethics Committees/Institutional Review Boards)

Exclusion criteria

• Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
• TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of EVARREST® to blood flow and pressure during healing and absorption of the product;
• TBS with major arterial bleeding requiring suture or mechanical ligation;
• Subjects admitted for trauma surgery;
• Subject is a transplant patient for fulminant hepatic failure
• Subject with 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 known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
• Subjects who are known, current alcohol and / or drug abusers;
• Subjects who have participated in another investigational medical device or investigational drug trial within 30 days of surgery or are expected to participate in another medical device or investigational drug trial during the course of the study;
• 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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102 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

Standard of Care (SoC)

Other 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. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).

Treatment:

Other: Standard of Care (SoC)