- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01166243
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
Intervention / Treatment
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
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South Australia
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Bedford Park, South Australia, Australia, 5042
- Flinders Medical Centre
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Woodville, South Australia, Australia, 5011
- Queen Elizabeth Hospital
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Victoria
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Melbourne, Victoria, Australia, 3044
- The Alfred
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Strasse, Germany, D-66421
- University Hospital of the University of Saarland
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Groningen, Netherlands, 9713
- University Medical Center
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Grafton, New Zealand, 1010
- Auckland City Hospital
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Birmingham, United Kingdom, B15 2TH
- Queen Elizabeth Hospital
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Cambridge, United Kingdom, CB2 0QQ
- Addenbrookes Hospital
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Edinburgh, United Kingdom, EH16 4SA
- Royal Infirmary of Edinburgh
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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
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Standard of Care is a composite of techniques/methods typically used by the surgeon to control bleeding.
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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
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Intra-operative
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects achieving hemostasis success at 10-minutes following randomization.
Time Frame: Intra-operative
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Intra-operative
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Absolute time to hemostasis
Time Frame: Intraoperative
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Intraoperative
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Subjects requiring re-treatment
Time Frame: Intraoperative
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Intraoperative
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Incidence of adverse events potentially related to re-bleeding at TBS
Time Frame: Intraoperative through 60 days
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Intraoperative through 60 days
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Incidence of adverse events potentially related to thrombotic events
Time Frame: Intraoperative through 60 days
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Intraoperative through 60 days
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Incidence of adverse events
Time Frame: Intraoperative through 60 days
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Intraoperative through 60 days
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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.
General Publications
- Koea JB, Batiller J, Patel B, Shen J, Hammond J, Hart J, Fischer C, Garden OJ. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HPB (Oxford). 2013 Jan;15(1):61-70. doi: 10.1111/j.1477-2574.2012.00583.x. Epub 2012 Oct 16.
- Corral M, Ferko N, Hollmann S, Hogan A, Jamous N, Batiller J, Shen J. Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials. Curr Med Res Opin. 2016;32(2):367-75. doi: 10.1185/03007995.2015.1128405. Epub 2015 Dec 21.
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.
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