The Severe Soft Tissue Bleeding Study

September 30, 2015 updated by: Ethicon, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

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

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

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, 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.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects achieving hemostatic success at 10 minutes following randomization
Time Frame: Intra-operative
Intra-operative
Absolute time to hemostasis
Time Frame: Intra-operative
Intra-operative
Proportion of subjects requiring re-treatment at the TBS prior to wound closure
Time Frame: Intra-operative
Intra-operative
Incidence of treatment failures
Time Frame: Intra-operative
Intra-operative
Incidence of adverse events that are potentially related to bleeding at the TBS
Time Frame: Intra-operative through 60 days
Intra-operative through 60 days
Incidence of adverse events that are potentially related to thrombotic events;
Time Frame: Intra-operative through 60 days
Intra-operative through 60 days
Incidence of adverse events
Time Frame: Intra-operative through 60 days
Intra-operative through 60 days

Collaborators and Investigators

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

Sponsor

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

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

August 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

September 15, 2009

First Submitted That Met QC Criteria

September 15, 2009

First Posted (Estimate)

September 16, 2009

Study Record Updates

Last Update Posted (Estimate)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 400-08-002

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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