Heparin for Radial Artery Occlusion

(EASY-Heparin Trial)

Not yet recruiting at 1 trial location

Overseen By Michele Jadin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Olivier F. Bertrand

Disqualifiers: Informed consent, Local condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether heparin, a common blood thinner, is always necessary after certain heart procedures using the radial artery in the wrist. Researchers compare the usual use of heparin with a more selective approach to determine which better prevents radial artery occlusion (blockage). Individuals scheduled for a diagnostic heart procedure through the wrist's artery and able to take common blood-thinning medications like aspirin might be suitable for this study.

As an unphased trial, this study provides an opportunity to contribute to important research that could enhance future heart procedures.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are unable to take certain blood-thinning medications like aspirin, clopidogrel, or heparin.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that heparin is generally safe for preventing blockages in the radial artery after procedures like catheterization. One study found that a heparin dose higher than 75 IU/kg reduced the risk of artery blockage by 80% compared to smaller doses. This indicates that heparin effectively protects the artery and is well-tolerated. When used correctly, heparin remains safe, provided care is taken to ensure proper blood flow during and after the procedure. Overall, heparin is a reliable and safe option in similar medical situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for radial artery occlusion, which typically involves administering heparin for anticoagulation, this trial is exploring the effects of not using heparin after trans-radial catheterization. Researchers are excited about this approach because it could reduce the risk of bleeding complications associated with heparin use. Additionally, skipping heparin might simplify post-procedure care and improve patient comfort. This trial aims to determine if patients can achieve effective hemostasis with dual-artery compression alone, potentially changing the standard treatment protocol.

What evidence suggests that this trial's treatments could be effective for preventing radial artery occlusion?

This trial will compare the use of heparin with no heparin for preventing radial artery occlusion (RAO) after trans-radial catheterization. Studies have shown that heparin effectively lowers the risk of a blockage in the radial artery after certain heart procedures. In one study, a higher dose of heparin resulted in fewer blockages, with only 3% of patients experiencing RAO compared to 8.1% with a standard dose. Another study found heparin more effective at preventing RAO than some other treatments, with a 3.5% RAO rate in the heparin group compared to 0.5% with another treatment. These findings suggest heparin effectively prevents complications like RAO during certain medical procedures. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone percutaneous catheterization and are at risk of radial artery occlusion. Specific eligibility criteria details were not provided, so it's unclear who exactly can or cannot participate.

Inclusion Criteria

I am referred for a diagnostic procedure through the wrist artery.

Exclusion Criteria

Presence of plethysmographic waveform with simultaneous radial and ulnar occlusive compression (due to collaterals or interosseous artery) precluding the evaluation of patent hemostasis

I have a condition that prevents access through my wrist for procedures.

I am unable to understand the study details or give informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a diagnostic trans-radial catheterization with either systematic or selective use of heparin

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of complications

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Heparin
• No heparin

Trial Overview The study is examining if using heparin routinely (as standard care) is more effective than using it selectively to prevent blockage in the radial artery after a catheter procedure with dual-artery compression.

How Is the Trial Designed?

Group I: No heparin Experimental Treatment 1 Intervention

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

Group II: Heparin Active Control 1 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.

Who Is Running the Clinical Trial?

Olivier F. Bertrand

Lead Sponsor

Trials

3

Recruited

600+

Citations

1. jacc.org jacc.org/doi/10.1016/j.jcin.2018.08.009

Multicenter Randomized Evaluation of High Versus ... In the high-dose heparin group, the rate of RAO was significantly lower compared with the standard-dose heparin group (27 [3.0%] vs. 75 [8.1%]; odds ratio: 0.35 ...

2. ahajournals.org ahajournals.org/doi/10.1161/jaha.115.002686

Radial Artery Occlusion After Transradial Interventions The most efficacious measure in reducing RAO was higher dose of heparin, because lower doses of heparin were associated with increased RAO (risk ratio 0.36, 95% ...

3. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2025.1535463/full

Short-term outcomes of unfractionated heparin vs. low ... A significant difference was found in radial artery occlusion (RAO) rates, with 3.5% in the heparin group vs. 0.5% in the enoxaparin group (P-value 0.032). No ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1109966625000089

Treatment of radial artery occlusion after transradial ... At the time of the first follow-up, the rate of recanalization of the radial artery was 31.5% after treatment with LMWH, as opposed to 5.4% in patients without ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01634438

NCT01634438 | Heparin Dose for Radial Angiography The main goal of this study is to determine the appropriate heparin dose to prevent wrist artery blockage and to determine risk factors for ...

6. jacc.org jacc.org/doi/10.1016/j.jcin.2018.09.018

Preventing Acute Radial Artery Occlusion: A Battle ... - JACC Additionally, the investigators demonstrated an 80% risk reduction for RAO using a heparin dose >75 IU/kg, compared with a heparin dose >50 IU/ ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06890312

the HERA-PCI Study (Heparin Early for Radial Access ... The expected outcomes include a reduction in the incidence of radial artery occlusion after the procedure, leading to a decrease in potential complications ( ...

8. scai.org scai.org/quality-improvement-tools/qi-tips/radial-artery-occlusion-after-transradial-cardiac-catheterization

Radial Artery Occlusion After Transradial Cardiac ... Comparison of the effect of intra-arterial versus intravenous heparin on radial artery occlusion after transradial catheterization. Am J Cardiol. 2009 Oct ...