Dual Artery Compression vs. Radial Artery-Only Hemostasis: Impact on Radial Artery Occlusion (EASY-RAO)

Not Applicable

• Conditions: Radial Artery Injury
• Interventions: Device: Hemostasis

• Registration Number: NCT04439513
• Lead Sponsor: Olivier F. Bertrand

Brief Summary

This study aims to demonstrate the superiority in clinical performances of a dual artery compression device (Terry-2 band) compared to a standard radial artery-only hemostasis device (HemoSTOP).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-15
• Study Start: 2020-06-18
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-19
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-28
• Last Update Posted: 2022-01-31
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• any patients referred for diagnostic angiography and possible percutaneous coronary intervention (PCI)

Exclusion Criteria

• Patient unable to understand study design or objectives
• Unable to sign informed consent
• Patient taking warfarin or other anticoagulant therapy
• Chronic RAO on both sides precluding TRA
• Previous ipsilateral transradial approach
• Inability to comply with the study follow-up
• Presence of plethysmographic waveform with radial and ulnar occlusive compression
• Pre-existing local complication (i.e. hematoma, pseudo-aneurysm, ...) precluding access-site evaluation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual Artery Compression	Hemostasis	time to hemostasis and incidence of radial artery occlusion will be monitored while using a dual artery compression device (Terry-2-band) to achieve hemostasis.
Radial Artery-Only	Hemostasis	time to hemostasis and incidence of radial artery occlusion will be monitored while using the device currently approved by the institution (Hemo-Stop) and following institutional protocols for hemostasis.

Primary Outcome Measures

Name	Time	Method
Rate of RAO after transradial approach (TRA) at hospital discharge	up to 24 hours	To determine whether the use of a dual artery compression decreases the rate of radial artery occlusion after transradial catheterization.

Secondary Outcome Measures

Name	Time	Method
Percentage of radial artery patent-hemostasis during hemostasis	throughout intervention, up to 180 minutes	To determine the conservation of blood flow through the radial artery during compressive hemostasis
Patient comfort during hemostasis as assessed on a visual scale	throughout intervention, up to 30 days	To evaluate the level of patient comfort in relation to the device used
Rates of complications such as repeat bleeding and hematoma (EASY Scale)	throughout intervention, up to 30 days	To determine the incidence of complications in relation to the device used. Bleeding, spasm and presence of hematomas will be evaluated.
Nursing involvement in hemostasis management for sensitivity analysis on cost assessment	throughout intervention, up to 24 hours	To determine the overall nursing involvement (time per nurse per patient) in hemostasis monitoring from end of procedure to patient discharge for a cost-benefit evaluation.

Trial Locations

Locations (1)

IUCPQ - Laval Hospital; 🇨🇦 Quebec, Canada