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Sponsors and Collaborators: |
Brigham and Women's Hospital Abbott Vascular |
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Information provided by: | Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT00838175 |
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.
Condition | Intervention |
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Cardiac Catheterization |
Procedure: suture mediated closure |
Study Type: | Observational |
Study Design: | Cohort, Retrospective |
Official Title: | Characteristics Predictive of Success and Complications in the Use of Suture-Mediated Closure of Femoral Venous Access |
Estimated Enrollment: | 250 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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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.
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Procedure: suture mediated closure
Suture mediated closure of femoral venous access
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Adult over the age of 18, who received a suture mediated closure of the femoral vein following catheterizaton at the BWH cath lab.
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Andrew C Eisenhauer, MD | Brigham and Women's Hospital |
Responsible Party: | Brigham and Women's Hospital ( Andrew C. Eisenhauer, MD ) |
Study ID Numbers: | 2007P-001023 |
Study First Received: | February 4, 2009 |
Last Updated: | February 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00838175 History of Changes |
Health Authority: | United States: Institutional Review Board |
Peripheral Venous Catheterization |