Clinical trial
Use of Nafamostat Mesilate for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation After Cardiac Surgery: Efficacy and Safety
Name
2023-102
Description
The purpose of this study is to evaluate the effectiveness and safety of nafamostat mesilate compared with unfractionated heparin for anticoagulation in patients with ECMO after cardiac surgery.
Trial arms
Trial start
2024-03-01
Estimated PCD
2026-03-01
Trial end
2026-12-31
Status
Not yet recruiting
Treatment
nafamostat mesilate
Use nafamostat mesilate as an anticoagulant
Arms:
nafamostat mesilate group
unfractionated heparin group
Use unfractionated heparin as an anticoagulant
Arms:
unfractionated heparin group
Size
80
Primary endpoint
Incidence of thrombotic complications
Within 7 days after starting anticoagulant therapy
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-02-26
1 organization
2 products
1 indication
Organization
Xiaotong HouProduct
NafamostatProduct
Unfractionated Heparin