Caring for the Radial Artery Post-angiogram

This study has been completed.
Sponsor:
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT01326455
First received: March 29, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

The purpose of this pilot study was to compare two devices and three methods for achieving hemostasis after a transradial angiogram while assessing vascular complications and time endpoints. The heart has traditionally been accessed through the femoral artery. However, in the last 20 years, the radial artery has gained more popularity among physicians and patients, thereby offering an alternative to the femoral approach. Various methods of applying compression to the radial puncture site have been used, but no research has been done to show what best practice is. In this case, best practice would be the most effective way of getting hemostasis while limiting complications and ensuring the efficient use of nursing and medical resources. It is hypothesized that statistically significant differences are seen in time to discharge in the fast-release Terumo and Clo-Sur P.A.D. groups, as compared with the control Terumo group, without increasing vascular complications.


Condition Intervention
Transradial Angiogram
Device: Terumo TR wristband
Device: Clo-Sur-P.A.D.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Caring for the Radial Artery Post-angiogram: A Pilot Study on a Comparison of Three Methods of Compression

Further study details as provided by University of Alberta:

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

Secondary Outcome Measures:
  • Time to Discharge
  • Hematoma or bruising
  • Radial Artery Occlusion

Enrollment: 75
Study Start Date: May 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Terumo Control Device: Terumo TR wristband
Active Comparator: Terumo Fast Release Device: Terumo TR wristband
Active Comparator: Clo-Sur P.A.D. Device: Clo-Sur-P.A.D.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • nonemergent
  • outpatient

Exclusion Criteria:

  • inpatients
  • emergency patients
  • booked angioplasty patients
  • cognitive impairment
  • those in whom the approach was initiated but aborted due to inability to puncture the radial artery
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Jennifer Fech
ClinicalTrials.gov Identifier: NCT01326455     History of Changes
Other Study ID Numbers: Pro00005016
Study First Received: March 29, 2011
Last Updated: March 29, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
transradial
angiogram
device
Care of the radial artery post transradial angiogram

ClinicalTrials.gov processed this record on September 18, 2014