HemorrhagePhase 3NCT01166243
The Fibrin Pad Liver Study
A Phase 3 study testing Fibrin Pad in people with Hemorrhage, run by Ethicon, Inc. at 9 sites in 5 countries.
Trial summary
The objective of this study is to evaluate the safety and and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage
- 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
- 84 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Jul 2010to Oct 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 or urgent, open hepatic surgery
- Presence of an appropriate bleeding hepatic parenchymal 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
- TBS 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
- TBS with major arterial bleeding requiring suture or mechanical ligation
- Subjects admitted for trauma surgery
- Subject is a transplant patient for fulminant hepatic failure
- Subject with TBS within an actively infected field
Show all 11Show fewer
- 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 or is unwilling to receive blood products
- 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 surgery
- Female subjects who are pregnant or nursing
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Australia3 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
The Alfred
Melbourne, Victoria, 3044
Queen Elizabeth Hospital
Woodville, South Australia, 5011
United Kingdom3 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
Addenbrookes Hospital
Cambridge, CB2 0QQ
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Germany1 site
University Hospital of the University of Saarland
Straße, D-66421
About this study
Official title: A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
The objective of this study is to evaluate the safety and and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.
- Conditions
- Hemorrhage
- Being tested
- Fibrin Pad, Standard of Care
- Keywords
- Hemostasis
- Medical subject headings
- Hemorrhage
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 bleeding.
| Study group | Role | What they receive |
|---|---|---|
| Fibrin Pad | Experimental | Biologic Receives: Biological: Fibrin Pad |
| Standard of Care | Other | Procedure 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 (TBS).
Measured: Intra-operative
Secondary outcomes (6)
Proportion of subjects achieving hemostasis success at 10-minutes following randomization.
Measured: Intra-operative
Absolute time to hemostasis
Measured: Intraoperative
Subjects requiring re-treatment
Measured: Intraoperative
Incidence of adverse events potentially related to re-bleeding at TBS
Measured: Intraoperative through 60 days
Incidence of adverse events potentially related to thrombotic events
Measured: Intraoperative through 60 days
Incidence of adverse events
Measured: Intraoperative 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 posted21 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies 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
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OMRIX Biopharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Jeff Hammond, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166243
- Sponsor's protocol ID
- 400-10-001
- Other IDs
- 2010-019427-58
- Status last verified
- Jan 2014
- First submitted
- 6 Jul 2010
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Koea JB, Batiller J, Patel B, Shen J, Hammond J, Hart J, Fischer C, Garden OJ. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HPB (Oxford). 2013 Jan;15(1):61-70. doi: 10.1111/j.1477-2574.2012.00583.x. Epub 2012 Oct 16.
PubMed 23216780Corral 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 20 Jan 2014. 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 Parenchymal Bleeding During Elective Hepatic Surgery
- ClinicalTrials.gov ID
- NCT01166243
- Acronym / sponsor ID
- 400-10-001
- Conditions
- Hemorrhage
- Keywords
- Hemostasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Collaborators
- OMRIX Biopharmaceuticals
- Study start
- Jul 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 21 Jul 2010 (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 and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrin Pad | Experimental | Biological: Fibrin PadBiologic |
| Standard of Care | Other | Procedure: Standard of CareProcedure |
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 or urgent, open hepatic surgery
- Presence of an appropriate bleeding hepatic parenchymal 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 (11 listed)
- Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
- TBS 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
- TBS with major arterial bleeding requiring suture or mechanical ligation
- Subjects admitted for trauma surgery
- Subject is a transplant patient for fulminant hepatic failure
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 bleeding. | Procedure or surgery | Standard of Care |
Primary outcome
Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS).
Time frame: Intra-operative
6 secondary outcomes
Proportion of subjects achieving hemostasis success at 10-minutes following randomization.
Time frame: Intra-operative
Absolute time to hemostasis
Time frame: Intraoperative
Subjects requiring re-treatment
Time frame: Intraoperative
Incidence of adverse events potentially related to re-bleeding at TBS
Time frame: Intraoperative through 60 days
Incidence of adverse events potentially related to thrombotic events
Time frame: Intraoperative through 60 days
Incidence of adverse events
Time frame: Intraoperative 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 20 Jan 2014.
- Results publication: PubMed 23216780Koea JB, Batiller J, Patel B, Shen J, Hammond J, Hart J, Fischer C, Garden OJ. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HPB (Oxford). 2013 Jan;15(1):61-70. doi: 10.1111/j.1477-2574.2012.00583.x. Epub 2012 Oct 16.
- 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.
Jeff Hammond, MD study director
Ethicon, Inc.
9 sites in 5 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 Hemorrhage, run by Ethicon, Inc. at 9 sites in 5 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 11 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 20 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia, United Kingdom, Germany, Netherlands, 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 (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 NCT01166243, which also lists 2 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 20 Jan 2014.