Cardiac CatheterizationNCT00838175
Characteristics Predictive of Success and Complications in the Use of Suture-Mediated Closure of Femoral Venous Access
An observational study of Cardiac Catheterization, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Suture-mediated closure devices are effective and safe for achieving rapid hemostasis in femoral venous access site and reducing the incidence of complications associated with traditional closure methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Catheterization
- What is being tested?
- suture mediated closure
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to May 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult over the age of 18, who received a suture mediated closure of the femoral vein following catheterizaton at the BWH cath lab.
Who may be able to join
- All consented pts. over the age of 18 who received sutured mediated femoral vein following catheterization
Who cannot join
- Pt.s who are unable to give consent.
- Pts. whose participation in research is contraindicated for medical reasons are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Suture-mediated closure devices are effective and safe for achieving rapid hemostasis in femoral venous access site and reducing the incidence of complications associated with traditional closure methods. Furthermore, there are predictive factors(such as sheath size, obesity, procedure duration, and anticoagulation status)that we can use to assess the procedure's likelihood of success in various patients.
Read the detailed description
This is a retrospective cohort study of consecutive patients receiving suture-mediated closure of the femoral vein following catheterization. All patients undergoing cardiac or arterial catheterization by the Interventional Cardiovascular Medicine Service at The Brigham and Women's hospital from 3/1/02 to the onset of the study and who had femoral venous access during that time were considered for closure of the venous site; however, the decision to use the closure device was left to the discretion of the physician. Contraindications to using the closure device include a groin hematoma that had developed during the procedure and/or difficult access due to extensive scar tissue from surgery or multiple prior vascular accesses.
All in-hospital endpoints have been collected in the pre-existing Catheterization Laboratory Database. Patient's data will be extracted from this database as indicated in the procedure below. Each patient will be reviewed for clinical follow-up and the presence of adverse events including but not limited to hematoma, thrombosis, blood loss, vascular imaging, the need for additional procedures, and re-admissions within 30 days of closure. If necessary, further data will be collected via a phone interview with the patients. Univariate and multivariate analysis will be performed to determine the factors that predict inadequate or incomplete closure or the development of complications mentioned in the section above. A predictive model based on the identified risk factor will be developed and tested prospectively in the next phase of this ongoing investigation.
- Conditions
- Cardiac Catheterization
- Being tested
- suture mediated closure
- Keywords
- Peripheral Venous Catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suture mediated closureProcedure or surgery
Also called Suture mediated closure of femoral venous access
Suture mediated closure of femoral venous access
| Study group | Role | What they receive |
|---|---|---|
| 1 | All pts. who have undergone percutaneous intervention who received a suture-mediated closure of the venous access site will be screened for eligibility for this research trial. Receives: Procedure: suture mediated closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and effectiveness of the suture-mediated closure devices in closing femoral venous access sites.
Measured: Within 30 days of procedure/closure
Secondary outcomes (1)
To identify factors that are predictive of success and failure of the suture mediated closures.
Measured: Within 30 days of procedure/closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startJun 2007
- Primary completionFeb 2009 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac CatheterizationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Investigators
- Andrew C Eisenhauer, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838175
- Sponsor's protocol ID
- 2007P-001023
- Status last verified
- Feb 2009
- First submitted
- 4 Feb 2009
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics Predictive of Success and Complications in the Use of Suture-Mediated Closure of Femoral Venous Access
- ClinicalTrials.gov ID
- NCT00838175
- Acronym / sponsor ID
- 2007P-001023
- Conditions
- Cardiac Catheterization
- Keywords
- Peripheral Venous Catheterization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Jun 2007
- Primary completion
- Feb 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 6 Feb 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.
Suture-mediated closure devices are effective and safe for achieving rapid hemostasis in femoral venous access site and reducing the incidence of complications associated with traditional closure methods. Furthermore, there are predictive factors(such as sheath size, obesity, procedure duration, and anticoagulation status)that we can use to assess the procedure's likelihood of success in various patients.
Detailed description
This is a retrospective cohort study of consecutive patients receiving suture-mediated closure of the femoral vein following catheterization. All patients undergoing cardiac or arterial catheterization by the Interventional Cardiovascular Medicine Service at The Brigham and Women's hospital from 3/1/02 to the onset of the study and who had femoral venous access during that time were considered for closure of the venous site; however, the decision to use the closure device was left to the discretion of the physician. Contraindications to using the closure device include a groin hematoma that had developed during the procedure and/or difficult access due to extensive scar tissue from surgery or multiple prior vascular accesses.
All in-hospital endpoints have been collected in the pre-existing Catheterization Laboratory Database. Patient's data will be extracted from this database as indicated in the procedure below. Each patient will be reviewed for clinical follow-up and the presence of adverse events including but not limited to hematoma, thrombosis, blood loss, vascular imaging, the need for additional procedures, and re-admissions within 30 days of closure. If necessary, further data will be collected via a phone interview with the patients. Univariate and multivariate analysis will be performed to determine the factors that predict inadequate or incomplete closure or the development of complications mentioned in the section above. A predictive model based on the identified risk factor will be developed and tested prospectively in the next phase of this ongoing investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: suture mediated closureAll pts. who have undergone percutaneous intervention who received a suture-mediated closure of the venous access site will be screened for eligibility for this research trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult over the age of 18, who received a suture mediated closure of the femoral vein following catheterizaton at the BWH cath lab.
Key inclusion criteria (1 listed)
- All consented pts. over the age of 18 who received sutured mediated femoral vein following catheterization
Key exclusion criteria (2 listed)
- Pt.s who are unable to give consent.
- Pts. whose participation in research is contraindicated for medical reasons are excluded.
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 |
|---|---|---|
| suture mediated closureAlso: Suture mediated closure of femoral venous accessSuture mediated closure of femoral venous access | Procedure or surgery | 1 |
Primary outcome
To determine the safety and effectiveness of the suture-mediated closure devices in closing femoral venous access sites.
Time frame: Within 30 days of procedure/closure
1 secondary outcome
To identify factors that are predictive of success and failure of the suture mediated closures.
Time frame: Within 30 days of procedure/closure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2009.
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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.
Andrew C Eisenhauer, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Catheterization, run by Brigham and Women's Hospital at 1 site 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
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?
To determine the safety and effectiveness of the suture-mediated closure devices in closing femoral venous access sites. (time frame: Within 30 days of procedure/closure). It is what the study was designed to measure, not a finding.
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 6 Feb 2009.