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Caring for the Radial Artery Post-angiogram

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01326455
First Posted: March 30, 2011
Last Update Posted: October 12, 2017
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.
Information provided by:
University of Alberta
  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
Intervention Model: Factorial Assignment
Masking: None (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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
No Contacts or Locations Provided
  More Information

Responsible Party: Jennifer Fech
ClinicalTrials.gov Identifier: NCT01326455     History of Changes
Other Study ID Numbers: Pro00005016
First Submitted: March 29, 2011
First Posted: March 30, 2011
Last Update Posted: October 12, 2017
Last Verified: March 2011

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