The Fibrin Pad Liver Study

Ethicon

Status and phase

Completed

Phase 3

Conditions

Hemorrhage

Treatments

Biological: Fibrin Pad

Procedure: Standard of Care

Study type

Interventional

Funder types

Industry

Identifiers

NCT01166243

2010-019427-58 (EudraCT Number)

400-10-001

Details and patient eligibility

About

The objective of this study is to evaluate the safety and and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.

Enrollment

84 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 must be willing to participate in the study, and provide written informed consent

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 the FP 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 drug or device research study within 30 days of surgery
Female subjects who are pregnant or nursing