The Fibrin Pad Liver Study

January 17, 2014 updated by: Ethicon, Inc.

A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Elective Hepatic Surgery

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
      • Woodville, South Australia, Australia, 5011
        • Queen Elizabeth Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3044
        • The Alfred
      • Strasse, Germany, D-66421
        • University Hospital of the University of Saarland
      • Groningen, Netherlands, 9713
        • University Medical Center
      • Grafton, New Zealand, 1010
        • Auckland City Hospital
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrookes Hospital
      • Edinburgh, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fibrin Pad
Biologic
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).
OTHER: Standard of Care
Procedure
Standard of Care is a composite of techniques/methods typically used by the surgeon to control bleeding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS).
Time Frame: Intra-operative
Intra-operative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Study Director: Jeff Hammond, MD, Ethicon, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

July 6, 2010

First Submitted That Met QC Criteria

July 20, 2010

First Posted (ESTIMATE)

July 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 400-10-001
  • 2010-019427-58 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemorrhage

Clinical Trials on Fibrin Pad

3
Subscribe