Peripheral Vascular DiseasePhase 3NCT00154141
Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures
A Phase 3 study testing Fibrin sealant (FS2) in people with Peripheral Vascular Disease, run by Ethicon, Inc. at 17 sites in 2 countries.
Trial summary
A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding during vascular procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Fibrin sealant (FS2)
- How many people
- 150 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Jun 2005to Mar 2006
- 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
- Male and female subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side femoral or upper extremity vascular access arterial anastomosis (e.g. femoral-femoral, femoral-popliteal, femoral-tibial, ilio-femoral, aorto-bifemoral, abdominal aortic aneurysm, upper extremity vascular access for dialysis) using uncoated or heparin-coated PTFE grafts and polypropylene sutures (size 5-0 or 6-0) with a 1:1 needle-to-thread ratio.
- Following initial arterial clamp release, the study surgeon determines that adjunctive measures are needed to obtain haemostasis at the SAS.
- Subjects must be willing to and capable of participating in the study, and provided written informed consent.
Who cannot join
- Subjects undergoing re-vascularisation using autologous conduits (e.g. saphenous vein) or prosthetic material other than uncoated or heparin-coated PTFE.
- Subjects undergoing emergency surgery.
- Subjects with any intra-operative findings that may preclude conduct of the study procedure.
- Subjects with known intolerance to heparin, blood products or to one of the components of the study product.
- Subjects unwilling to receive blood products.
- Subjects with autoimmune 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 enrolment.
- Female subjects who are pregnant or nursing.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States13 sites
Alband Medical Center
Albany, New York, 12208
Millarad Fillmore Hospital, SUNY
Buffalo, New York, 14209
UVA Health System
Charlottesville, Virginia, 22908
Iowa Heart Center
Des Moines, Iowa, 50314
Hackensack Medical Center
Hackensack, New Jersey, 07601
Baptist Medical Center
Jacksonville, Florida, 32216
Memorial Hospital
Jacksonville, Florida, 32216
Jackson Memorial Hospital
Miami, Florida, 33103
Vanderbilt Univ Medical Center
Nashville, Tennessee, 37232
Vascular and Transplant Specialists
Norfolk, Virginia, 23503
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Jobst Vascular Center
Toledo, Ohio, 43606
Univ of Mass Medical Center
Worcester, Massachusetts, 01655
United Kingdom4 sites
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
Birmingham Heartlands Hospital
Birmingham, B9 5SS
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Hull Royal Infirmary
Hull, HU3 2JZ
About this study
Official title: A Prospective, Randomized Controlled Study to Compare the Effects of a Fibrin Sealant (FS2) Versus Manual Compression on Haemostatic Efficacy During Vascular Surgical Procedures Utilising Polytetrafluorethylene Graft Material on an End-to-Side Femoral or Upper Extremity Vascular Access Arterial Anastomosis
A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding during vascular procedures.
- Conditions
- Peripheral Vascular Disease
- Being tested
- Fibrin sealant (FS2)
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin sealant (FS2)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Attainment of hemostasis at following randomization.
Secondary outcomes (4)
Attainment of hemostasis following randomization.
Incidence of treatment failures
Incidence of potential bleeding-related complications
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2005
- Study completionMar 2006
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 Peripheral Vascular DiseaseStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OMRIX Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154141
- Sponsor's protocol ID
- 400-05-001
- Status last verified
- Jul 2006
- First submitted
- 7 Sep 2005
- Last updated
- 13 Jul 2006
- Results posted
- No
Publications
Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.
PubMed 38695613Chalmers RT, Darling Iii RC, Wingard JT, Chetter I, Cutler B, Kern JA, Hart JC. Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures. Br J Surg. 2010 Dec;97(12):1784-9. doi: 10.1002/bjs.7235. Epub 2010 Aug 20.
PubMed 20730858
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Study to Compare the Effects of a Fibrin Sealant (FS2) Versus Manual Compression on Haemostatic Efficacy During Vascular Surgical Procedures Utilising Polytetrafluorethylene Graft Material on an End-to-Side Femoral or Upper Extremity Vascular Access Arterial Anastomosis
- ClinicalTrials.gov ID
- NCT00154141
- Acronym / sponsor ID
- 400-05-001
- Conditions
- Peripheral Vascular Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Collaborators
- OMRIX Biopharmaceuticals
- Study start
- Jun 2005
- Study completion
- Mar 2006
- First posted
- 12 Sep 2005 (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.
A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding during vascular procedures.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side femoral or upper extremity vascular access arterial anastomosis (e.g. femoral-femoral, femoral-popliteal, femoral-tibial, ilio-femoral, aorto-bifemoral, abdominal aortic aneurysm, upper extremity vascular access for dialysis) using uncoated or heparin-coated PTFE grafts and polypropylene sutures (size 5-0 or 6-0) with a 1:1 needle-to-thread ratio.
- Following initial arterial clamp release, the study surgeon determines that adjunctive measures are needed to obtain haemostasis at the SAS.
- Subjects must be willing to and capable of participating in the study, and provided written informed consent.
Key exclusion criteria (9 listed)
- Subjects undergoing re-vascularisation using autologous conduits (e.g. saphenous vein) or prosthetic material other than uncoated or heparin-coated PTFE.
- Subjects undergoing emergency surgery.
- Subjects with any intra-operative findings that may preclude conduct of the study procedure.
- Subjects with known intolerance to heparin, 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 sealant (FS2) | Drug | – |
Primary outcome
Attainment of hemostasis at following randomization.
4 secondary outcomes
Attainment of hemostasis following randomization.
Incidence of treatment failures
Incidence of potential bleeding-related complications
Adverse events
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 13 Jul 2006.
- Derived from this study: PubMed 38695613Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.
- Derived from this study: PubMed 20730858Chalmers RT, Darling Iii RC, Wingard JT, Chetter I, Cutler B, Kern JA, Hart JC. Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures. Br J Surg. 2010 Dec;97(12):1784-9. doi: 10.1002/bjs.7235. Epub 2010 Aug 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fibrin sealant (FS2) in people with Peripheral Vascular Disease, run by Ethicon, Inc. at 17 sites in 2 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 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 13 Jul 2006. 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 States, United Kingdom. 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?
Attainment of hemostasis at following randomization.. 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 NCT00154141, 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 13 Jul 2006.