Femoral Vascular AnastomosisNCT00163592
Post-Marketing Surveillance of TISSUCOL for Hemostasis in Subjects Undergoing Vascular Reconstruction With Polytetrafluoroethylene (PTFE) Prosthesis
An observational study of Femoral Vascular Anastomosis, run by Baxter Healthcare Corporation at 5 sites in 2 countries.
Trial summary
This study investigates if the time to hemostasis can be reduced by application of Tissucol® onto femoral vascular anastomoses with PTFE prostheses compared to standard methods, such as compression with swabs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Femoral Vascular Anastomosis
- What is being tested?
- Tissucol®
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2003to Feb 2004
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Subjects with femoral vascular anastomosis and bleeding suture holes after vessel reconstruction with a PTFE prosthesis
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany3 sites
Leonberg Hospital, Department of Vascular Surgery
Leonberg, 71229
University Clinics of Magdeburg, Department of Vascular Surgery
Magdeburg, 39120
Klinikum Nürnberg Süd, Department of Vascular Surgery
Nuremberg, 90340
Austria2 sites
Landeskrankenhaus Innsbruck
Innsbruck, Tyrol, 6020
General Hospital (AKH) Salzburg
Salzburg, State of Salzburg, 5020
About this study
Official title: Non- Interventional Study of Tissucol® for Hemostasis in Subjects With Femoral Vascular Anastomosis Undergoing Vascular Reconstruction With PTFE Prosthesis
This study investigates if the time to hemostasis can be reduced by application of Tissucol® onto femoral vascular anastomoses with PTFE prostheses compared to standard methods, such as compression with swabs.
- Conditions
- Femoral Vascular Anastomosis
- Being tested
- Tissucol®, Control: Conventional treatment, i.e. compression with swabs
- Keywords
- Vascular reconstruction, Polytetraflouroethylene (PTFE) prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissucol®Drug
Control: Conventional treatment, i.e. compression with swabsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2003
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Vascular AnastomosisStudies 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
- Observational
- Time perspective
- Other
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Bürger, MD, Principal investigator, University Clinics of Magdeburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163592
- Sponsor's protocol ID
- 530301
- Status last verified
- Oct 2006
- First submitted
- 8 Sep 2005
- Last updated
- 23 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non- Interventional Study of Tissucol® for Hemostasis in Subjects With Femoral Vascular Anastomosis Undergoing Vascular Reconstruction With PTFE Prosthesis
- ClinicalTrials.gov ID
- NCT00163592
- Acronym / sponsor ID
- 530301
- Conditions
- Femoral Vascular Anastomosis
- Keywords
- Vascular reconstruction, Polytetraflouroethylene (PTFE) prosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Feb 2004
- First posted
- 14 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.
This study investigates if the time to hemostasis can be reduced by application of Tissucol® onto femoral vascular anastomoses with PTFE prostheses compared to standard methods, such as compression with swabs.
Study design
- Time perspective
- Other
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Tissucol® | Drug | – |
| Control: Conventional treatment, i.e. compression with swabs | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 23 Oct 2006.
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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.
Thomas Bürger, MD principal investigator
University Clinics of Magdeburg, Germany
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Vascular Anastomosis, run by Baxter Healthcare Corporation at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Austria. 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.
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.
Where can I read the original study information?
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 23 Oct 2006.