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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOlivier F. Bertrand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Any patient referred for a diagnostic transradial catheterism

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • No heparin

    Other intervention

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

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: HeparinNo intervention 0 interventions
Group B: No heparinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rates of patent hemostasis

Evaluation of patent hemostasis by pulse oximetry

Time frame
within 24 hours after diagnostic angiography
2

Time to hemostasis

Time frame
within 24 hours post-procedure
3

Nursing time involvement

Calculation of nursing time required for surveillance and care of hemostasis

Time frame
within 24 hours post-procedure
4

Evaluation of complications

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

Time frame
within 30 days of procedure

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Olivier F. Bertrand

Lead sponsor

Laval University

Sponsor institution