The Fibrin Pad Liver Study

Phase 3

Completed

• Conditions: Hemorrhage
• Interventions: Biological: Fibrin Pad; Procedure: Standard of Care

• Registration Number: NCT01166243
• Lead Sponsor: Ethicon, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-20
• Study First Posted: 2010-07-21
• Primary Completion: 2011-08
• Study Completion: 2011-10
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-17
• Last Update Posted: 2014-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fibrin Pad	Fibrin Pad	Biologic
Standard of Care	Standard of Care	Procedure

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS).	Intra-operative

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events potentially related to thrombotic events	Intraoperative through 60 days
Incidence of adverse events	Intraoperative through 60 days
Proportion of subjects achieving hemostasis success at 10-minutes following randomization.	Intra-operative
Absolute time to hemostasis	Intraoperative
Subjects requiring re-treatment	Intraoperative
Incidence of adverse events potentially related to re-bleeding at TBS	Intraoperative through 60 days

Trial Locations

Locations (8)

Addenbrookes Hospital; 🇬🇧 Cambridge, United Kingdom

University Hospital of the University of Saarland; 🇩🇪 Strasse, Germany

Auckland City Hospital; 🇳🇿 Grafton, New Zealand

Queen Elizabeth Hospital; 🇬🇧 Birmingham, United Kingdom

The Alfred; 🇦🇺 Melbourne, Victoria, Australia

University Medical Center; 🇳🇱 Groningen, Netherlands

Flinders Medical Centre; 🇦🇺 Bedford Park, South Australia, Australia

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom