Comparison of the Systematic Versus the Selective Use of Heparin for the Prevention of Radial Artery Occlusion

NCT06981624 | Recruiting

• 1 other identifier: EASY-Heparin
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized study comparing the systematic use of heparin (standard of care) against an elective use of heparin to prevent radial artery occlusion after a percutaneous catheterization using a dual-artery compression system.

Conditions

Radial Artery Occlusion

Outcome Measures

Primary Outcomes (4)

• Rates of patent hemostasis

  Evaluation of patent hemostasis by pulse oximetry

  within 24 hours after diagnostic angiography

• Time to hemostasis

  within 24 hours post-procedure

• Nursing time involvement

  Calculation of nursing time required for surveillance and care of hemostasis

  within 24 hours post-procedure

• Evaluation of complications

  Compilation of access site complications such as radial artery occlusion, bleeding, presence and grading of hematomas, etc.

  within 30 days of procedure

Study Arms (2)

Heparin

NO INTERVENTION

Standard of care with 70-100 IU/kg of heparin after a diagnostic only trans-radial catheterization and a dual-artery compression device for hemostasis.

No heparin

EXPERIMENTAL

No heparin administered after diagnostic only trans-radial catheterization and a dual-artery compression device for hemostasis.

Other: No heparin

Interventions

No heparin OTHER

Hemostasis achieved using a dual-artery compression device without administration of heparin after trans-radial diagnostic catheterization

No heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient referred for a diagnostic transradial catheterism

You may not qualify if:

• Unable to understand study design or provide informed consent
• Unable to receive antiplatelet therapy with aspirina and/or clopidogrel-prasugrel and/or ticagrelor and intravenous anticoagulant derived from heparine or bivalirudine
• Local condition such as hematoma or pseudo-aneurims precluding radial or ulnar access.
• Presence of plethysmographic waveform with simultaneous radial and ulnar occlusive compression (due to colaterals or interouseous artery) precluding the evaluation of patent hemostasis.

Sponsors & Collaborators

• Olivier F. Bertrand: lead

Study Sites (1)

IUCPQ

Québec, Quebec, G1V4G5, Canada

RECRUITING

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Michele Jadin

CONTACT

418-656-8711; michele.jadin@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 21, 2025
• Study Start: May 13, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2025-05

Locations

CA (1)