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

Cardiac Catheterization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00838175
• Other study ID #: 2007P-001023
• Status: Unknown status
• Phase: N/A
• First received: February 4, 2009
• Last updated: February 5, 2009
• Start date: June 2007
• Est. completion date: May 2009

Study information

• Verified date: February 2009
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 250
• Est. completion date: May 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Catheterization

Intervention

Procedure:
• suture mediated closure
Suture mediated closure of femoral venous access

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Abbott Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety and effectiveness of the suture-mediated closure devices in closing femoral venous access sites.		Within 30 days of procedure/closure
Secondary	To identify factors that are predictive of success and failure of the suture mediated closures.		Within 30 days of procedure/closure