Nafamostat mesilate versus heparin for anticoagulation in ECMO after cardiac surgery
Use of Nafamostat Mesilate for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation After Cardiac Surgery: Efficacy and Safety
This study will test whether nafamostat mesilate works better than unfractionated heparin for anticoagulation in adults on ECMO after cardiac surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Anzhen Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06276010 on ClinicalTrials.gov |
What this trial studies
Adults requiring systemic anticoagulation while on VA- or VV-ECMO after cardiac surgery will be randomly assigned to receive either nafamostat mesilate or standard unfractionated heparin. The trial compares incidence of bleeding and thrombosis while keeping anticoagulation within target levels during ECMO support. Safety outcomes and complication rates will be recorded and compared between the two groups. The design aims to determine if nafamostat provides similar or improved anticoagulation with fewer bleeding events.
Who should consider this trial
Good fit: Adults aged 18 or older who receive VA- or VV-ECMO after cardiac surgery, require systemic anticoagulation, and can sign informed consent are the intended participants.
Not a fit: Patients with active bleeding from other causes, prior long-term anticoagulant or antiplatelet use before ECMO, severe liver insufficiency, connective tissue disease, known allergy to heparin or nafamostat, prior heparin-induced thrombocytopenia, pregnancy, expected death within 48 hours, or those receiving ECPR are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, nafamostat could reduce bleeding and thrombotic complications during ECMO and improve patient outcomes compared with standard heparin.
How similar studies have performed: Small case series and observational reports, primarily from Asia, suggest nafamostat can provide anticoagulation with potentially less bleeding during extracorporeal support, but randomized evidence is currently limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years old 2. VA-ECMO or VV-ECMO was accepted after cardiac surgery. 3. The ECMO treatment team believes that systemic anticoagulation is needed 4. Sign the informed consent form Exclusion Criteria: 1. The researchers believe that there are other causes of active bleeding that are not suitable to participate in this study. 2. Long-term use of anticoagulants before establishment of ECMO 3. Antiplatelet drugs were used before the establishment of ECMO 4. Severe liver insufficiency 5. Connective tissue disease 6. There is a history of allergy to heparin or nemolastat mesylate. 7. Pregnant 8. Previous diagnosis of heparin-induced thrombocytopenia 9. Expect to die within 48 hours 10. ECPR
Where this trial is running
Beijing, Beijing Municipality
- Beijing Anzhen Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xiaotong Hou, MD
- Email: xt.hou@ccmu.edu.cn
- Phone: 010-64456631
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.