Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO

Xiaotong Hou

Status: Enrolling

Conditions: Extracorporeal Membrane Oxygenation Complication

Treatments: Drug: unfractionated heparin group; Drug: nafamostat mesilate

Study type: Interventional

Funder types: Other

Identifiers

NCT06276010

2023-102

Details and patient eligibility

About

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.

Full description

Selecting patients who require systemic anticoagulation as the study subjects from patients undergoing extracorporeal membrane oxygenation assistance after cardiac surgery. Randomly divided into the nafamostat mesilate group and unfractionated heparin group. To evaluate the efficacy and safety of nafamostat mesilate by comparing the incidence of bleeding and thrombosis within the target anticoagulant level range between two groups of patients during ECMO

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

nafamostat mesilate group

Experimental group

Description:

The initial dosing of the nafamostat mesilate group is 0.5mg/kg/h. We maintain ACT at 180\~220s by adjusting the dosage of nafamostat mesilate.

Treatment:

Drug: nafamostat mesilate

unfractionated heparin group

Other group

Description:

The initial dosing of the unfractionated heparin group is 8\~12U/kg/h. We maintain ACT at 180\~220s by adjusting the dosage of unfractionated heparin .

Treatment:

Drug: unfractionated heparin group