Bivalirudin versus heparin for blood thinning during ECMO
Official title: Efficacy and Safety of Bivalirudin Versus Heparin in Anticoagulant Therapy of ECMO: a Randomized Controlled Trial
Run by Beijing Anzhen Hospital · NCT06275555 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 154 (estimated) |
| Sponsor | Beijing Anzhen Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | June 3, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | March 1, 2027 |
| Registry record updated | April 6, 2026 |
| Trial ID | NCT06275555 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Some observational series and small trials have suggested bivalirudin can offer more stable anticoagulation on ECMO, but large randomized comparisons remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Xiaotong Hou, MD
- Email: xt.hou@ccmu.edu.cn
- Phone: 010-64456631
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.