Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
84 participants
INTERVENTIONAL
2010-07-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fibrin Pad
Biologic
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.
Interventions
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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
Standard of Care is a composite of techniques/methods typically used by the surgeon to control bleeding.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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OMRIX Biopharmaceuticals
INDUSTRY
Ethicon, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeff Hammond, MD
Role: STUDY_DIRECTOR
Ethicon, Inc.
Locations
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Flinders Medical Centre
Bedford Park, South Australia, Australia
Queen Elizabeth Hospital
Woodville, South Australia, Australia
The Alfred
Melbourne, Victoria, Australia
University Hospital of the University of Saarland
Straße, , Germany
University Medical Center
Groningen, , Netherlands
Auckland City Hospital
Grafton, , New Zealand
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2010-019427-58
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
400-10-001
Identifier Type: -
Identifier Source: org_study_id
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