Prevention of Radial Artery Occlusion: Prophylactic Hyperperfusion Evaluation Trial

Phase 4

Completed

• Conditions: Occlusion of Artery
• Interventions: Procedure: Ulnar artery compression

• Registration Number: NCT01564888
• Lead Sponsor: Total Cardiovascular Solutions

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-26
• Study First Posted: 2012-03-28
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-14
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patent hemostasis	Ulnar artery compression	Patent hemostasis is the technique for radial artery hemostasis after transradial catheterization, with proactive attempt to maintain radial artery hemostasis and radial artery patency.
Ulnar artery compression	Ulnar artery compression	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.

Primary Outcome Measures

Name	Time	Method
30 day radial artery occlusion	30 days	Evaluation of radial artery patency using plethysmography

Secondary Outcome Measures

Name	Time	Method
hand ischemia	2 hours	evaluated by clinical evaluation for neurosensory deficit or other clinical signs of ischemia.

Trial Locations

Locations (2)

University Hospital and Faculty of Medicine; 🇨🇿 Pilsen, Czechia

V.S. General hospital; 🇮🇳 Ahmedabad, Gujarat, India