Caring for the Radial Artery Post-angiogram

Not Applicable

Completed

• Conditions: Transradial Angiogram
• Interventions: Device: Terumo TR wristband; Device: Clo-Sur-P.A.D.

• Registration Number: NCT01326455
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-30
• Status Verified: 2011-09
• Results First Submitted: 2011-09-22
• Results First Submitted QC: 2022-09-13
• Last Update Submitted: 2022-09-13
• Results First Posted: 2022-09-28
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Terumo Fast Release	Terumo TR wristband	-
Clo-Sur P.A.D.	Clo-Sur-P.A.D.	-
Terumo Control	Terumo TR wristband	-

Primary Outcome Measures

Name	Time	Method
Bleeding Requiring Intervention After Initial Hemostasis Achieved	Assessed after initial hemostasis achieved	Number of Participants with Bleeding Requiring Intervention after initial hemostasis achieved
Bleeding Requiring Intervention Post-CATH Day 1	Assessed post-CATH Day 1	Number of Participants with Bleeding Requiring Intervention post-CATH Day 1

Secondary Outcome Measures

Name	Time	Method
Hematoma or Bruising Post-CATH Day 1	Assessed post-CATH day 1.	Number of Participants with hematoma or bruising post-CATH Day 1
Hematoma or Bruising at Discharge	Assessed at discharge	Number of Participants with hematoma or bruising at discharge
Time to Discharge	Assessed on day of angiogram.	Time to discharge in minutes.
Radial Artery Occlusion Post-CATH	Assessed via plethysmography and palpation post-CATH	Number of Participants with Radial Artery Occlusion post-CATH
Radial Artery Occlusion Post-CATH Day 1	Assessed via plethysmography and palpation post-CATH day 1.	Number of Participants with Radial Artery Occlusion post-CATH Day 1