Bivalirudin versus heparin for blood thinning during ECMO

Efficacy and Safety of Bivalirudin Versus Heparin in Anticoagulant Therapy of ECMO: a Randomized Controlled Trial

This trial tests whether bivalirudin keeps anticoagulation closer to target and reduces clotting or bleeding compared with standard heparin in adults on VA- or VV-ECMO.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 154 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06275555 on ClinicalTrials.gov

What this trial studies

Adults on veno-arterial or veno-venous ECMO who need systemic anticoagulation are randomly assigned to receive either bivalirudin or unfractionated heparin with a target APTT of 40–60 seconds. The main efficacy measure is the percentage of time the anticoagulation level stays within the target range and the incidence of thrombotic complications during ECMO. Safety is measured by bleeding events, blood product transfusions, and occurrence of acute renal failure. The trial is conducted at Beijing Anzhen Hospital and compares outcomes between the two anticoagulation strategies during the ECMO course.

Who should consider this trial

Good fit: Adults aged 18 or older on VA- or VV-ECMO who require systemic anticoagulation, can maintain APTT at 40–60 seconds, have been on ECMO less than 48 hours before randomization, and can provide consent are ideal candidates.

Not a fit: Patients with prior heparin or bivalirudin allergy, a history of heparin-induced thrombocytopenia, pregnant women, those already on ECMO more than 48 hours before enrollment, or with other investigator-determined exclusions are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, bivalirudin could provide more stable anticoagulation and lower rates of clotting or bleeding for adults supported with ECMO.

How similar studies have performed: Some observational series and small trials have suggested bivalirudin can offer more stable anticoagulation on ECMO, but large randomized comparisons remain limited.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years old
2. Accept VA-ECMO or VV-ECMO
3. the ECMO team believes that systemic anticoagulation is necessary and that APTT should be maintained at 40-60s.
4. sign the informed consent form

Exclusion Criteria:

1. previous history of allergy to heparin or bivalirudin
2. previous diagnosis of heparin-induced thrombocytopenia.
3. the pre-random ECMO assistance time is more than 48 hours.
4. pregnant female
5. have participated in this study before.
6. the researchers believe that there are other factors that are not suitable to participate in this study.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Anzhen Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xiaotong Hou, MD

Conditions Extracorporeal Membrane Oxygenation Complication