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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiac Catheterization
• Intervention / Treatment: 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
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: suture mediated closure; Suture mediated closure of femoral venous access; Other Names: Suture mediated closure of femoral venous access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
To identify factors that are predictive of success and failure of the suture mediated closures.	Within 30 days of procedure/closure

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Andrew C Eisenhauer, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (ANTICIPATED): February 1, 2009
• Study Completion (ANTICIPATED): May 1, 2009

Study Registration Dates

• First Submitted: February 4, 2009
• First Submitted That Met QC Criteria: February 5, 2009
• First Posted (ESTIMATE): February 6, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): February 6, 2009
• Last Update Submitted That Met QC Criteria: February 5, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Peripheral Venous Catheterization
• Other Study ID Numbers: 2007P-001023