Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00977925




Registration number
NCT00977925
Ethics application status
Date submitted
15/09/2009
Date registered
16/09/2009
Date last updated
1/10/2015

Titles & IDs
Public title
The Severe Soft Tissue Bleeding Study
Scientific 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
Secondary ID [1] 0 0
400-08-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soft Tissue Bleeding 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Fibrin Pad
Treatment: Surgery - Standard of Care

Experimental: Fibrin Pad -

Active Comparator: Standard of Care -


Other interventions: 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).

Treatment: Surgery: Standard of Care
Standard of Care is a composite of techniques/methods typically used by the surgeon to control severe bleeding.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects achieving hemostasis at the Target Bleeding Site. Hemostasis is defined as no detectable bleeding at the TBS.
Timepoint [1] 0 0
Intra-operative
Secondary outcome [1] 0 0
Proportion of subjects achieving hemostatic success at 10 minutes following randomization
Timepoint [1] 0 0
Intra-operative
Secondary outcome [2] 0 0
Absolute time to hemostasis
Timepoint [2] 0 0
Intra-operative
Secondary outcome [3] 0 0
Proportion of subjects requiring re-treatment at the TBS prior to wound closure
Timepoint [3] 0 0
Intra-operative
Secondary outcome [4] 0 0
Incidence of treatment failures
Timepoint [4] 0 0
Intra-operative
Secondary outcome [5] 0 0
Incidence of adverse events that are potentially related to bleeding at the TBS
Timepoint [5] 0 0
Intra-operative through 60 days
Secondary outcome [6] 0 0
Incidence of adverse events that are potentially related to thrombotic events;
Timepoint [6] 0 0
Intra-operative through 60 days
Secondary outcome [7] 0 0
Incidence of adverse events
Timepoint [7] 0 0
Intra-operative through 60 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2011
Sample size
Target
Accrual to date
Final
91
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Bankstown Hospital - Bankstown
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
The Townsville Hospital - Douglas
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
- Bankstown
Recruitment postcode(s) [2] 0 0
- Bedford Park
Recruitment postcode(s) [3] 0 0
- Douglas
Recruitment postcode(s) [4] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Heidelberg
Country [2] 0 0
Germany
State/province [2] 0 0
Homburg/Saar
Country [3] 0 0
Germany
State/province [3] 0 0
Karlsruhe
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Birmingham
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Cambridge
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Edinburgh
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Leeds
Country [9] 0 0
United Kingdom
State/province [9] 0 0
London
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ethicon, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00977925
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Hart, MD
Address 0 0
Ethicon, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00977925