The Fibrin Pad Liver Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01166243
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : January 20, 2014
OMRIX Biopharmaceuticals
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hemorrhage Biological: Fibrin Pad Procedure: Standard of Care Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
Study Start Date : July 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Fibrin Pad
Biological: Fibrin Pad
Fibrin Pad 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).

Standard of Care
Procedure: Standard of Care
Standard of Care is a composite of techniques/methods typically used by the surgeon to control bleeding.

Primary Outcome Measures :
  1. Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS). [ Time Frame: Intra-operative ]

Secondary Outcome Measures :
  1. Proportion of subjects achieving hemostasis success at 10-minutes following randomization. [ Time Frame: Intra-operative ]
  2. Absolute time to hemostasis [ Time Frame: Intraoperative ]
  3. Subjects requiring re-treatment [ Time Frame: Intraoperative ]
  4. Incidence of adverse events potentially related to re-bleeding at TBS [ Time Frame: Intraoperative through 60 days ]
  5. Incidence of adverse events potentially related to thrombotic events [ Time Frame: Intraoperative through 60 days ]
  6. Incidence of adverse events [ Time Frame: Intraoperative through 60 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01166243

Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Queen Elizabeth Hospital
Woodville, South Australia, Australia, 5011
Australia, Victoria
The Alfred
Melbourne, Victoria, Australia, 3044
University Hospital of the University of Saarland
Strasse, Germany, D-66421
University Medical Center
Groningen, Netherlands, 9713
New Zealand
Auckland City Hospital
Grafton, New Zealand, 1010
United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
Sponsors and Collaborators
Ethicon, Inc.
OMRIX Biopharmaceuticals
Study Director: Jeff Hammond, MD Ethicon, Inc.