Characteristics Predictive of Success and Complications in the Use of Suture-Mediated Closure of Femoral Venous Access

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00838175
Recruitment Status : Unknown
Verified February 2009 by Brigham and Women's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : February 6, 2009
Last Update Posted : February 6, 2009
Abbott Vascular
Information provided by:
Brigham and Women's Hospital

Brief 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. 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 or disease Intervention/treatment
Cardiac Catheterization Procedure: suture mediated closure

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 Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Characteristics Predictive of Success and Complications in the Use of Suture-Mediated Closure of Femoral Venous Access
Study Start Date : June 2007
Estimated Primary Completion Date : February 2009
Estimated Study Completion Date : May 2009

Group/Cohort Intervention/treatment
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.
Procedure: suture mediated closure
Suture mediated closure of femoral venous access
Other Name: Suture mediated closure of femoral venous access

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To identify factors that are predictive of success and failure of the suture mediated closures. [ Time Frame: Within 30 days of procedure/closure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Inclusion Criteria:

  • All consented pts. over the age of 18 who received sutured mediated femoral vein following catheterization

Exclusion Criteria:

  • Pt.s who are unable to give consent.
  • Pts. whose participation in research is contraindicated for medical reasons are excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00838175

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Abbott Vascular
Principal Investigator: Andrew C Eisenhauer, MD Brigham and Women's Hospital

Responsible Party: Andrew C. Eisenhauer, MD, Brigham and Women's Hospital Identifier: NCT00838175     History of Changes
Other Study ID Numbers: 2007P-001023
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009

Keywords provided by Brigham and Women's Hospital:
Peripheral Venous Catheterization