Soft Tissue BleedingPhase 3NCT00977925
The Severe Soft Tissue Bleeding Study
A Phase 3 study testing Fibrin Pad in people with Soft Tissue Bleeding, run by Ethicon, Inc. at 17 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Bleeding
- What is being tested?
- Fibrin Pad
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 17 sitesin 4 countries
- Study dates
- Aug 2009to Mar 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
United Kingdom6 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
Addenbrookes Hospital
Cambridge, CB2 0QQ
The Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
St. James University Hospital
Leeds, LS9 7TF
St Bartholomew's Hospital
London, EC1A 2BE
Nottingham City Hospital
Nottingham, NG5 1PB
Australia4 sites
Bankstown Hospital
Bankstown
Flinders Medical Centre
Bedford Park
The Townsville Hospital
Douglas
Royal Melbourne Hospital
Parkville
Germany4 sites
Department of Surgery, University of Heidelberg
Heidelberg, 69120
Krankenhaus Salem
Heidelberg, 69121
University Hospital of the University of Saarland
Homburg/Saar, Homburg/Saar, D-66421
Vincentius-Klinken
Karlsruhe
New Zealand3 sites
Auckland City Hospital
Auckland, 1023
Auckland City Hospital
Auckland
North Shore Hospital
Auckland
About this 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
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.
- Conditions
- Soft Tissue Bleeding
- Being tested
- Fibrin Pad, Standard of Care
- Keywords
- Hemostasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin PadBiological
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).
Standard of CareProcedure or surgery
Standard of Care is a composite of techniques/methods typically used by the surgeon to control severe bleeding.
| Study group | Role | What they receive |
|---|---|---|
| Fibrin Pad | Experimental | Not described Receives: Biological: Fibrin Pad |
| Standard of Care | Active comparator | Not described Receives: Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving hemostasis at the Target Bleeding Site. Hemostasis is defined as no detectable bleeding at the TBS.
Measured: Intra-operative
Secondary outcomes (7)
Proportion of subjects achieving hemostatic success at 10 minutes following randomization
Measured: Intra-operative
Absolute time to hemostasis
Measured: Intra-operative
Proportion of subjects requiring re-treatment at the TBS prior to wound closure
Measured: Intra-operative
Incidence of treatment failures
Measured: Intra-operative
Incidence of adverse events that are potentially related to bleeding at the TBS
Measured: Intra-operative through 60 days
Incidence of adverse events that are potentially related to thrombotic events;
Measured: Intra-operative through 60 days
Incidence of adverse events
Measured: Intra-operative through 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Hart, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977925
- Sponsor's protocol ID
- 400-08-002
- Status last verified
- Sep 2015
- First submitted
- 15 Sep 2009
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26216641Koea 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.
PubMed 26041587Corral 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.
PubMed 26636489
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00977925
- Acronym / sponsor ID
- 400-08-002
- Conditions
- Soft Tissue Bleeding
- Keywords
- Hemostasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 16 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrin Pad | Experimental | Biological: Fibrin Pad |
| Standard of Care | Active comparator | Procedure: Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrin PadFibrin 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). | Biological | Fibrin Pad |
| Standard of CareStandard of Care is a composite of techniques/methods typically used by the surgeon to control severe bleeding. | Procedure or surgery | Standard of Care |
Primary outcome
Proportion of subjects achieving hemostasis at the Target Bleeding Site. Hemostasis is defined as no detectable bleeding at the TBS.
Time frame: Intra-operative
7 secondary outcomes
Proportion of subjects achieving hemostatic success at 10 minutes following randomization
Time frame: Intra-operative
Absolute time to hemostasis
Time frame: Intra-operative
Proportion of subjects requiring re-treatment at the TBS prior to wound closure
Time frame: Intra-operative
Incidence of treatment failures
Time frame: Intra-operative
Incidence of adverse events that are potentially related to bleeding at the TBS
Time frame: Intra-operative through 60 days
Incidence of adverse events that are potentially related to thrombotic events;
Time frame: Intra-operative through 60 days
Incidence of adverse events
Time frame: Intra-operative through 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
- Results publication: PubMed 26216641Koea 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 publication: PubMed 26041587Koea 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.
- Derived from this study: PubMed 26636489Corral 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Hart, MD study director
Ethicon, Inc.
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fibrin Pad in people with Soft Tissue Bleeding, run by Ethicon, Inc. at 17 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom, Australia, Germany, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving hemostasis at the Target Bleeding Site. Hemostasis is defined as no detectable bleeding at the TBS. (time frame: Intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00977925, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2015.