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

Randomized Comparison f Dual Artery Compression Versus Radial Artery-Only Hemostasis: Impact on Radial Artery Occlusion (EArly Discharge After Transradial Stenting of coronarY Arteries - EASY-RAO)

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).

Study Overview

• Status: Recruiting
• Conditions: Radial Artery Injury
• Intervention / Treatment: Device: Hemostasis

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivier F Bertrand; Phone Number: 4186568711; Email: olivier.bertrand@crhl.ulaval.ca
• Study Contact Backup: Name: Michèle Jadin; Phone Number: 3007 4186568711

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Recruiting
    • IUCPQ - Laval Hospital
    • Principal Investigator: Tomas Cieza, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dual Artery Compression; 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.	Device: Hemostasis; Compression device to achieve hemostasis.
Active Comparator: Radial Artery-Only; 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.	Device: Hemostasis; Compression device to achieve hemostasis.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of radial artery patent-hemostasis during hemostasis	To determine the conservation of blood flow through the radial artery during compressive hemostasis	throughout intervention, up to 180 minutes
Patient comfort during hemostasis as assessed on a visual scale	To evaluate the level of patient comfort in relation to the device used	throughout intervention, up to 30 days
Rates of complications such as repeat bleeding and hematoma (EASY Scale)	To determine the incidence of complications in relation to the device used. Bleeding, spasm and presence of hematomas will be evaluated.	throughout intervention, up to 30 days
Nursing involvement in hemostasis management for sensitivity analysis on cost assessment	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.	throughout intervention, up to 24 hours

Collaborators and Investigators

• Sponsor: Olivier F. Bertrand

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Hemostasis; RAO; TRA
• Additional Relevant MeSH Terms: Coagulants; Hemostatics
• Other Study ID Numbers: EASY-RAO; 2020-3400, 21885 (Other Identifier: IUCPQ)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No