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Caring for the Radial Artery Post-angiogram

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ClinicalTrials.gov Identifier: NCT01326455
Recruitment Status : Completed
First Posted : March 30, 2011
Last Update Posted : March 30, 2011
Sponsor:
Information provided by:
University of Alberta

Brief Summary:
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 or disease Intervention/treatment Phase
Transradial Angiogram Device: Terumo TR wristband Device: Clo-Sur-P.A.D. Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
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
Study Start Date : May 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Bleeding Requiring Intervention

Secondary Outcome Measures :
  1. Time to Discharge
  2. Hematoma or bruising
  3. Radial Artery Occlusion


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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

Responsible Party: Jennifer Fech
ClinicalTrials.gov Identifier: NCT01326455     History of Changes
Other Study ID Numbers: Pro00005016
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: March 30, 2011
Last Verified: March 2011

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