The Severe Soft Tissue Bleeding Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00977925
First received: September 15, 2009
Last updated: March 5, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Soft Tissue Bleeding
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: Single Blind (Subject)
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

Further study details as provided by Ethicon, Inc.:

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

Secondary Outcome Measures:
  • Proportion of subjects achieving hemostatic success at 10 minutes following randomization [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]
  • Absolute time to hemostasis [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]
  • Proportion of subjects requiring re-treatment at the TBS prior to wound closure [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]
  • Incidence of treatment failures [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]
  • Incidence of adverse events that are potentially related to bleeding at the TBS [ Time Frame: Intra-operative through 60 days ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events that are potentially related to thrombotic events; [ Time Frame: Intra-operative through 60 days ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events [ Time Frame: Intra-operative through 60 days ] [ Designated as safety issue: Yes ]

Enrollment: 91
Study Start Date: August 2009
Study Completion Date: March 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  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, 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.
  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: NCT00977925

Locations
Australia
Bankstown Hospital
Bankstown, Australia
Flinders Medical Centre
Bedford Park, Australia
The Townsville Hospital
Douglas, Australia
Royal Melbourne Hospital
Parkville, Australia
Germany
Krankenhaus Salem
Heidelberg, Germany, 69121
Department of Surgery, University of Heidelberg
Heidelberg, Germany, 69120
University Hospital of the University of Saarland
Homburg/Saar, Germany, D-66421
Vincentius-Klinken
Karlsruhe, Germany
New Zealand
Auckland City Hospital
Auckland, New Zealand
North Shore Hospital
Auckland, New Zealand
Auckland City Hospital
Auckland, New Zealand, 1023
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.
Investigators
Study Director: James Hart, MD Ethicon, Inc.
  More Information

No publications provided

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00977925     History of Changes
Other Study ID Numbers: 400-08-002
Study First Received: September 15, 2009
Last Updated: March 5, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Paul-Ehrlich-Institut

Keywords provided by Ethicon, Inc.:
Hemostasis

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014