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The Severe Soft Tissue Bleeding 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: NCT00977925
Recruitment Status : Completed
First Posted : September 16, 2009
Last Update Posted : October 1, 2015
Information provided by (Responsible Party):
Ethicon, Inc.

Brief Summary:
The objective of this study is to evaluate the safety and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling challenging severe soft tissue bleeding during abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic surgery.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Severe Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery
Study Start Date : August 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : March 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).

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

Primary Outcome Measures :
  1. Proportion of subjects achieving hemostasis at the Target Bleeding Site. Hemostasis is defined as no detectable bleeding at the TBS. [ Time Frame: Intra-operative ]

Secondary Outcome Measures :
  1. Proportion of subjects achieving hemostatic success at 10 minutes following randomization [ Time Frame: Intra-operative ]
  2. Absolute time to hemostasis [ Time Frame: Intra-operative ]
  3. Proportion of subjects requiring re-treatment at the TBS prior to wound closure [ Time Frame: Intra-operative ]
  4. Incidence of treatment failures [ Time Frame: Intra-operative ]
  5. Incidence of adverse events that are potentially related to bleeding at the TBS [ Time Frame: Intra-operative through 60 days ]
  6. Incidence of adverse events that are potentially related to thrombotic events; [ Time Frame: Intra-operative through 60 days ]
  7. Incidence of adverse events [ Time Frame: Intra-operative 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, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures;
  • Presence of an appropriate severe bleeding soft tissue 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;
  • Bleeding site 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;
  • 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;
  • Subjects unwilling to receive blood products;
  • Subjects with known immunodeficiency diseases (including known HIV);
  • 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 enrollment;
  • 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): NCT00977925

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Bankstown Hospital
Bankstown, Australia
Flinders Medical Centre
Bedford Park, Australia
The Townsville Hospital
Douglas, Australia
Royal Melbourne Hospital
Parkville, Australia
Department of Surgery, University of Heidelberg
Heidelberg, Germany, 69120
Krankenhaus Salem
Heidelberg, Germany, 69121
University Hospital of the University of Saarland
Homburg/Saar, Germany, D-66421
Karlsruhe, Germany
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1023
Auckland City Hospital
Auckland, New Zealand
North Shore Hospital
Auckland, New Zealand
United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
The Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
St. James University Hospital
Leeds, United Kingdom, LS9 7TF
St Bartholomew's Hospital
London, United Kingdom, EC1A 2BE
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Ethicon, Inc.
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Study Director: James Hart, MD Ethicon, Inc.

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ethicon, Inc. Identifier: NCT00977925     History of Changes
Other Study ID Numbers: 400-08-002
First Posted: September 16, 2009    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015

Keywords provided by Ethicon, Inc.:

Additional relevant MeSH terms:
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Pathologic Processes