Efficacy and Safety of Nafamostat Mesylate for ECMO Anticoagulation

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to compare the efficacy and safety of nafamostat mesylate and unfractionated heparin during ECMO anticoagulation in critically ill patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Calcium heparin; Heparin; Nafamostat

Criteria

Inclusion Criteria:

• Patients aged >= 18 and <= 75 years;

• Successfully established ECMO (VA/VV) treatment by percutaneous puncture due to cardiogenic shock or respiratory failure;

• Anticoagulation required during ECMO treatment; Before the establishment of ECMO, the APTT test value was within the normal range, and the platelets were not less than 80G/L;

• Within 48 hours of ECMO establishment, APTT test results were between 1 and 1.75 times the upper limit of normal, PLT>80 G/L, and no serious bleeding and thrombosis;

• Sign the informed consent.

Exclusion Criteria:

• Pregnant;

• Bleeding risk or active bleeding;

• Pre-existing diseases requiring long-term anticoagulation before ECMO: pulmonary embolism, deep vein thrombosis, intraventricular thrombosis, atrial fibrillation, etc.;

• Long-term use of anticoagulants before ECMO;

• Antiplatelet drugs were used before ECMO;

• Allergy to heparin, nafamostat mesylate;

• Repeated puncture at the same site for more than 3 times;

• Expected ECMO treatment time < 3 days;

• Patients with an expected survival period of less than 48 hours;

• Patients undergoing extracorporeal cardiopulmonary resuscitation;

• Burn patients; Blood purification treatment using polyacrylonitrile membrane filter;

• Heterozygous ECMO mode or ECMO therapy solely for CO2 removal;

• Other reasons that the investigator considers inappropriate for inclusion;