Caring for the Radial Artery Post-angiogram

Study Overview
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Brief Summary
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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.

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

Conditions
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Transradial Angiogram

Intervention / Treatment
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* Device: Terumo TR wristband
* Device: Terumo TR wristband
* Device: Clo-Sur-P.A.D.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Terumo Control<br> | Device: Terumo TR wristband<br>* 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.<br>|
| Active Comparator: Terumo Fast Release<br> | Device: Terumo TR wristband<br>* 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.<br>|
| Active Comparator: Clo-Sur P.A.D.<br> | Device: Clo-Sur-P.A.D.<br>* 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.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transradial, angiogram, device, Care of the radial artery post transradial angiogram