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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Brigham and Women's Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Abbott Vascular
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00838175
First received: February 4, 2009
Last updated: February 5, 2009
Last verified: February 2009
  Purpose

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
Cardiac Catheterization
Procedure: suture mediated closure

Study Type: Observational
Study Design: 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

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To identify factors that are predictive of success and failure of the suture mediated closures. [ Time Frame: Within 30 days of procedure/closure ] [ Designated as safety issue: No ]

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
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 Name: Suture mediated closure of femoral venous access

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838175

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

No publications provided

Responsible Party: Andrew C. Eisenhauer, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00838175     History of Changes
Other Study ID Numbers: 2007P-001023
Study First Received: February 4, 2009
Last Updated: February 5, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 16, 2014