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

Tracking Information
First Received Date ^ICMJE	March 29, 2011
Last Updated Date	March 29, 2011
Start Date ^ICMJE	May 2009
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 29, 2011)	Bleeding Requiring Intervention [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: March 29, 2011)	Time to Discharge Hematoma or bruising Radial Artery Occlusion
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Caring for the Radial Artery Post-angiogram
Official Title ^ICMJE	Caring for the Radial Artery Post-angiogram: A Pilot Study on a Comparison of Three Methods of Compression
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Transradial Angiogram
Intervention ^ICMJE	Device: Terumo TR wristband Device: Clo-Sur-P.A.D.
Study Arm (s)	No Intervention: Terumo Control Intervention: Device: Terumo TR wristband Active Comparator: Terumo Fast Release Intervention: Device: Terumo TR wristband Active Comparator: Clo-Sur P.A.D. Intervention: Device: Clo-Sur-P.A.D.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	75
Completion Date	March 2010
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01326455
Other Study ID Numbers ^ICMJE	Pro00005016
Has Data Monitoring Committee	No
Responsible Party	Jennifer Fech
Study Sponsor ^ICMJE	University of Alberta
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Alberta
Verification Date	March 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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