Prevention of Radial Artery Occlusion: Prophylactic Hyperperfusion Evaluation Trial

Study Overview
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Brief Summary
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Evaluating the effect of ulnar artery compression while pressing on radial artery to stop bleeding, in maintaining radial artery potency, after cardiac catheterization through the radial artery. We prospectively plan to compare 3000 patients referred for cardiac catheterization, randomized into two groups, one group receiving radial artery compression for stopping bleeding, in a standard fashion following best practices, and the other group receiving radial artery compression using standard best practices and ulnar artery compression. Radial artery status will be evaluated in 24 hours and 30 days of the procedure to evaluate its potency, using plethysmography.

Official Title
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Prevention of Radial Artery Occlusion: Prophylactic Hyperperfusion Evaluation Trial

Conditions
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Occlusion of Artery

Intervention / Treatment
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* Procedure: Ulnar artery compression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients referred for diagnostic cardiac catheterization. Exclusion Criteria: previous ipsilateral radial artery puncture, warfarin therapy, absence of intact palmar collateral circulation, scleroderma, ipsilateral radial artery surgery, lone upper extremity (contralateral upper extremity amputation), ipsilateral upper extremity chronic pain.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Patent hemostasis<br>Patent hemostasis is the technique for radial artery hemostasis after transradial catheterization, with proactive attempt to maintain radial artery hemostasis and radial artery patency. | Procedure: Ulnar artery compression<br>* Compression of ulnar artery for 2 hours with radial artery hemostasis<br>|
| Active Comparator: Ulnar artery compression<br>Ulnar artery compression will involve radial artery hemostasis using patent hemostasis technique and compression of ulnar artery to the point of occluding flow, in an attempt to augment radial artery flow. | Procedure: Ulnar artery compression<br>* Compression of ulnar artery for 2 hours with radial artery hemostasis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day radial artery occlusion | Evaluation of radial artery patency using plethysmography | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hand ischemia | evaluated by clinical evaluation for neurosensory deficit or other clinical signs of ischemia. | 2 hours |