Caring for the Radial Artery Post-angiogram

Caring for the Radial Artery Post-angiogram: A Pilot Study on a Comparison of Three Methods of Compression

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.

Study Overview

• Status: Completed
• Conditions: Transradial Angiogram
• Intervention / Treatment: Device: Terumo TR wristband; Device: Terumo TR wristband; Device: Clo-Sur-P.A.D.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Terumo Control	Device: Terumo TR wristband; A transparent unilateral compression device which is secured to the wrist via strap with velcro. The portion with the deflated 18cc balloon is placed directly over the puncture site. This balloon is inflated immediately after the catheter is removed and the balloon is inflated until bleeding visibly stops, with generally 9-18cc of air. First deflation of 3cc of air occurred 1 hour after inflation. Deflations occurred every 15 minutes unless bleeding was noted. If bleeding was noted, balloon was reinflated (1-3cc of air) until bleeding stopped. Next deflation occurred 30 minutes later, at which point regular 15 minutes deflations occurred if no bleeding noted. Band was removed 1 hour after final deflation.; Device: Terumo TR wristband; A transparent unilateral compression device which is secured to the wrist via strap with velcro. The portion with the deflated 18cc balloon is placed directly over the puncture site. This balloon is inflated immediately after the catheter is removed and the balloon is inflated until bleeding visibly stops, with generally 9-18cc of air. First balloon deflation of 3cc of air occurred 15 minutes after initial inflation. Deflations occurred every 15 minutes unless bleeding was noted. If active bleeding was noted, the balloon was re-inflated (1-3cc) until bleeding stopped. The next deflation occurred 15 minutes later. If no bleeding occurred, deflations continued every 15 minutes until the balloon was completely deflated. The band was removed 15 minutes after final deflation.
ACTIVE_COMPARATOR: Terumo Fast Release	Device: Terumo TR wristband; A transparent unilateral compression device which is secured to the wrist via strap with velcro. The portion with the deflated 18cc balloon is placed directly over the puncture site. This balloon is inflated immediately after the catheter is removed and the balloon is inflated until bleeding visibly stops, with generally 9-18cc of air. First deflation of 3cc of air occurred 1 hour after inflation. Deflations occurred every 15 minutes unless bleeding was noted. If bleeding was noted, balloon was reinflated (1-3cc of air) until bleeding stopped. Next deflation occurred 30 minutes later, at which point regular 15 minutes deflations occurred if no bleeding noted. Band was removed 1 hour after final deflation.; Device: Terumo TR wristband; A transparent unilateral compression device which is secured to the wrist via strap with velcro. The portion with the deflated 18cc balloon is placed directly over the puncture site. This balloon is inflated immediately after the catheter is removed and the balloon is inflated until bleeding visibly stops, with generally 9-18cc of air. First balloon deflation of 3cc of air occurred 15 minutes after initial inflation. Deflations occurred every 15 minutes unless bleeding was noted. If active bleeding was noted, the balloon was re-inflated (1-3cc) until bleeding stopped. The next deflation occurred 15 minutes later. If no bleeding occurred, deflations continued every 15 minutes until the balloon was completely deflated. The band was removed 15 minutes after final deflation.
ACTIVE_COMPARATOR: Clo-Sur P.A.D.	Device: Clo-Sur-P.A.D.; A hydrophilic dressing has a high affinity for water, and absorbs and controls body fluid. The positively charged 4x4 centimetre pad reacts with the neuraminic acid residue on red blood cells causing agglutination of the cells. The Clo-Sur P.A.D. works outside of the clotting cascade. The radial catheter was removed and occlusive pressure applied on the radial artery. Pressure was released just until bleeding noted & the pad was applied with approximately 5 minutes of manual compression. The pad was assessed every 15 minutes for 90 minutes to ensure hemostasis. The pad was removed on post-CATH day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding Requiring Intervention After Initial Hemostasis Achieved	Number of Participants with Bleeding Requiring Intervention after initial hemostasis achieved	Assessed after initial hemostasis achieved
Bleeding Requiring Intervention Post-CATH Day 1	Number of Participants with Bleeding Requiring Intervention post-CATH Day 1	Assessed post-CATH Day 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Colleen Norris, PhD, University of Alberta

Publications and helpful links

General Publications

• Fech JC, Welsh R, Hegadoren K, Norris CM. Caring for the radial artery post-angiogram: a pilot study on a comparison of three methods of compression. Eur J Cardiovasc Nurs. 2012 Mar;11(1):44-50. doi: 10.1177/1474515111429656. Epub 2012 Jan 11.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (ACTUAL): March 1, 2010
• Study Completion (ACTUAL): March 1, 2010

Study Registration Dates

• First Submitted: March 29, 2011
• First Submitted That Met QC Criteria: March 29, 2011
• First Posted (ESTIMATE): March 30, 2011

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: transradial; device; angiogram; Care of the radial artery post transradial angiogram
• Other Study ID Numbers: Pro00005016