The Fibrin Pad Liver Study

This study has been completed.
Sponsor:
Collaborator:
OMRIX Biopharmaceuticals
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT01166243
First received: July 6, 2010
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Hemorrhage
Biological: Fibrin Pad
Procedure: Standard of Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS). [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects achieving hemostasis success at 10-minutes following randomization. [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]
  • Absolute time to hemostasis [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
  • Subjects requiring re-treatment [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
  • Incidence of adverse events potentially related to re-bleeding at TBS [ Time Frame: Intraoperative through 60 days ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events potentially related to thrombotic events [ Time Frame: Intraoperative through 60 days ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events [ Time Frame: Intraoperative through 60 days ] [ Designated as safety issue: Yes ]

Enrollment: 84
Study Start Date: July 2010
Study Completion Date: October 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fibrin Pad
Biologic
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
Procedure: Standard of Care
Standard of Care is a composite of techniques/methods typically used by the surgeon to control bleeding.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166243

Locations
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
Germany
University Hospital of the University of Saarland
Strasse, Germany, D-66421
Netherlands
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
Investigators
Study Director: Jeff Hammond, MD Ethicon, Inc.
  More Information

Publications:
Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT01166243     History of Changes
Other Study ID Numbers: 400-10-001, 2010-019427-58
Study First Received: July 6, 2010
Last Updated: January 17, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Paul-Ehrlich-Institut
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe

Keywords provided by Ethicon, Inc.:
Hemostasis

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014