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The Severe Soft Tissue Bleeding Study

Primary Purpose

Soft Tissue Bleeding

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fibrin Pad
Standard of Care
Sponsored by
Ethicon, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Bleeding focused on measuring Hemostasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bankstown Hospital
  • Flinders Medical Centre
  • The Townsville Hospital
  • Royal Melbourne Hospital
  • Department of Surgery, University of Heidelberg
  • Krankenhaus Salem
  • University Hospital of the University of Saarland
  • Vincentius-Klinken
  • Auckland City Hospital
  • Auckland City Hospital
  • North Shore Hospital
  • Queen Elizabeth Hospital
  • Addenbrookes Hospital
  • The Royal Infirmary of Edinburgh
  • St. James University Hospital
  • St Bartholomew's Hospital
  • Nottingham City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fibrin Pad

Standard of Care

Arm Description

Outcomes

Primary Outcome Measures

Proportion of subjects achieving hemostasis at the Target Bleeding Site. Hemostasis is defined as no detectable bleeding at the TBS.

Secondary Outcome Measures

Proportion of subjects achieving hemostatic success at 10 minutes following randomization
Absolute time to hemostasis
Proportion of subjects requiring re-treatment at the TBS prior to wound closure
Incidence of treatment failures
Incidence of adverse events that are potentially related to bleeding at the TBS
Incidence of adverse events that are potentially related to thrombotic events;
Incidence of adverse events

Full Information

First Posted
September 15, 2009
Last Updated
September 30, 2015
Sponsor
Ethicon, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00977925
Brief Title
The Severe Soft Tissue Bleeding Study
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 Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Bleeding
Keywords
Hemostasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fibrin Pad
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Fibrin Pad
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care is a composite of techniques/methods typically used by the surgeon to control severe bleeding.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Proportion of subjects achieving hemostatic success at 10 minutes following randomization
Time Frame
Intra-operative
Title
Absolute time to hemostasis
Time Frame
Intra-operative
Title
Proportion of subjects requiring re-treatment at the TBS prior to wound closure
Time Frame
Intra-operative
Title
Incidence of treatment failures
Time Frame
Intra-operative
Title
Incidence of adverse events that are potentially related to bleeding at the TBS
Time Frame
Intra-operative through 60 days
Title
Incidence of adverse events that are potentially related to thrombotic events;
Time Frame
Intra-operative through 60 days
Title
Incidence of adverse events
Time Frame
Intra-operative through 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Hart, MD
Organizational Affiliation
Ethicon, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Bankstown Hospital
City
Bankstown
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
Country
Australia
Facility Name
The Townsville Hospital
City
Douglas
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
Country
Australia
Facility Name
Department of Surgery, University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Krankenhaus Salem
City
Heidelberg
ZIP/Postal Code
69121
Country
Germany
Facility Name
University Hospital of the University of Saarland
City
Homburg/Saar
ZIP/Postal Code
D-66421
Country
Germany
Facility Name
Vincentius-Klinken
City
Karlsruhe
Country
Germany
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
Facility Name
North Shore Hospital
City
Auckland
Country
New Zealand
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
The Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
St. James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 2BE
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26216641
Citation
Koea J, Baldwin P, Shen J, Patel B, Batiller J, Arnaud A, Hart J, Hammond J, Fischer C, James Garden O. Erratum to: Safety and Hemostatic Effectiveness of the Fibrin Pad for Severe Soft-Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic (Non-cardiac) Surgery: A Randomized, Controlled, Superiority Trial. World J Surg. 2015 Oct;39(10):2610. doi: 10.1007/s00268-015-3163-9. No abstract available.
Results Reference
result
PubMed Identifier
26041587
Citation
Koea J, Baldwin P, Shen J, Patel B, Batiller J, Arnaud A, Hart J, Hammond J, Fischer C, James Garden O. Safety and Hemostatic Effectiveness of the Fibrin Pad for Severe Soft-Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic (Non-cardiac) Surgery: A Randomized, Controlled, Superiority Trial. World J Surg. 2015 Nov;39(11):2663-9. doi: 10.1007/s00268-015-3106-5. Erratum In: World J Surg. 2015 Oct;39(10):2610.
Results Reference
result
PubMed Identifier
26636489
Citation
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.
Results Reference
derived

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The Severe Soft Tissue Bleeding Study

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