HemostasisPhase 2NCT00658723
The Fibrin Patch Soft Tissue Study
A Phase 2 study testing Fibrin Pad and SURGICEL™ in people with Hemostasis, run by Ethicon, Inc. at 11 sites in United States.
Trial summary
The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in 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
- Hemostasis
- What is being tested?
- Fibrin Pad and SURGICEL™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2008to May 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 non-emergent, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures
- Presence of an appropriate soft tissue Target Bleeding Site (TBS) as identified intraoperatively 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
- 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 immunodeficiency diseases (including known HIV)
Show all 9Show fewer
- 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
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Emory University Hospital
Atlanta, Georgia, 30322
Medical College of Georgia
Augusta, Georgia, 30912
University of Maryland Medical Center
Baltimore, Maryland, 21201
St. Agnes Healthcare, Inc.
Baltimore, Maryland, 21229
University of Alabama
Birmingham, Alabama, 35294
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Weill Medical Colleges of Cornell University - Methodist Hospital
Houston, Texas, 77030
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Baptist Hosptial
Miami, Florida, 33173
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
About this study
Official title: A Prospective, Randomized, Controlled, Superiority Evaluation of Fibrin Patch as an Adjunct to Control Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery
The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.
- Conditions
- Hemostasis
- Being tested
- Fibrin Pad, SURGICEL™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin PadDrug
Fibrin Patch 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).
SURGICEL™Device
Absorbable hemostat
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Fibrin Pad |
| 2 | Active comparator | SURGICEL™ Absorbable Hemostat Receives: Device: SURGICEL™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Achieving Hemostatic Success
Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period.
Measured: Intra-operative
Secondary outcomes (7)
Proportion of Subjects Achieving Hemostatic Success
The proportion of subjects achieving hemostatic success at 10 minutes following randomization
Measured: 10 minutes
Incidence of Treatment Failures
If hemostasis was not achieved within 4 minutes or if bleeding required additional intervention during the 6 minute observation period, the treatment was considered to be a failure.
Measured: Intra-operative
Incidence of Adverse Events That Are Potentially Related to Bleeding
The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS).
Measured: Intra-operative up to 1 month (+14 days)
Incidence of Adverse Events That Are Potentially Related to Thrombotic Events
The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism
Measured: Intra-operative up to 1 month (+14 days)
Incidence of Adverse Events Potentially Related to Transfusion Exposure
The types of events that were potentially related to transfusion exposure could have include hypocalcemia.
Measured: Intra-operative up to 1 month (+14 days)
Incidence of Re-treatment
The outcome measure assess if re-treatment was done after release of manual compression at 4-minutes for subjects not achieving hemostatic success or if re-treatment was done during the 6-minute observation period.
In the SURGICEL group, 18 subjects had initial hemostatic success at 4 minutes, but 2 of the 18 subjects were re-treated for re-bleeding. In the SURGICEL group, 12 subjects were not hemostatic at 4-minutes and had a re-treatment.
Measured: Intra-operative
Incidence of Adverse Events
Measured: 30 days (+14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemostasisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OMRIX Biopharmaceuticals
- Responsible party
- Sponsor
- Investigators
- James Hart, M.D., Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658723
- Sponsor's protocol ID
- 400-07-002
- Status last verified
- Sep 2014
- First submitted
- 11 Apr 2008
- Last updated
- 11 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fischer CP, Bochicchio G, Shen J, Patel B, Batiller J, Hart JC. A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery. J Am Coll Surg. 2013 Sep;217(3):385-93. doi: 10.1016/j.jamcollsurg.2013.02.036.
PubMed 23969113Corral 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 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Superiority Evaluation of Fibrin Patch as an Adjunct to Control Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery
- ClinicalTrials.gov ID
- NCT00658723
- Acronym / sponsor ID
- 400-07-002
- Conditions
- Hemostasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Collaborators
- OMRIX Biopharmaceuticals
- Study start
- Mar 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 15 Apr 2008 (estimated)
- Results
- Posted 11 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fibrin Pad |
| 2 | Active comparator | Device: SURGICEL™SURGICEL™ Absorbable Hemostat |
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 non-emergent, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures
- Presence of an appropriate soft tissue Target Bleeding Site (TBS) as identified intraoperatively by the surgeon
- Subjects must be willing to participate in the study, and provide written informed consent
Key exclusion criteria (9 listed)
- Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
- 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
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 Patch 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). | Drug | 1 |
| SURGICEL™Absorbable hemostat | Device | 2 |
Primary outcome
Proportion of Subjects Achieving Hemostatic Success
Time frame: Intra-operative
Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period.
7 secondary outcomes
Proportion of Subjects Achieving Hemostatic Success
Time frame: 10 minutes
Incidence of Treatment Failures
Time frame: Intra-operative
Incidence of Adverse Events That Are Potentially Related to Bleeding
Time frame: Intra-operative up to 1 month (+14 days)
Incidence of Adverse Events That Are Potentially Related to Thrombotic Events
Time frame: Intra-operative up to 1 month (+14 days)
Incidence of Adverse Events Potentially Related to Transfusion Exposure
Time frame: Intra-operative up to 1 month (+14 days)
Incidence of Re-treatment
Time frame: Intra-operative
Incidence of Adverse Events
Time frame: 30 days (+14 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23969113Fischer CP, Bochicchio G, Shen J, Patel B, Batiller J, Hart JC. A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery. J Am Coll Surg. 2013 Sep;217(3):385-93. doi: 10.1016/j.jamcollsurg.2013.02.036.
- 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, M.D. study director
Ethicon, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fibrin Pad and SURGICEL™ in people with Hemostasis, run by Ethicon, Inc. at 11 sites in United States.
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 9 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 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Hemostatic Success (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 NCT00658723, 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 11 Sep 2014.