Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation

Xiaobo Yang, MD

Status and phase: Enrolling; Phase 2

Conditions: Anticoagulation; Critical Illness

Treatments: Drug: Nafamostat Mesylate; Drug: Unfractionated Heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT05555641

NMST20211022

Details and patient eligibility

About

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.

Full description

During ECMO treatment, nafamostat mesylate and unfractionated heparin were randomly administered for continuous anticoagulation, respectively, and the incidence of bleeding and thrombotic complications during anticoagulation was compared between the two groups.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged >= 18 and <= 80 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Nafamostat Mesylate

Experimental group

Description:

VV-ECMO patients were given continuous anticoagulation with nafamostat mesylate, coagulation function was monitored every 6 hours, and APTT was maintained at 1-1.75 times the upper limit of normal detection until reaching the study endpoints, including 14 days after enrollment, 24 hours after withdrawal from ECMO, or any switch to ECMO mode during ECMO treatment.

Treatment:

Drug: Nafamostat Mesylate

Unfractionated Heparin

Active Comparator group

Description:

VV-ECMO patients were given continuous anticoagulation with unfractionated heparin, coagulation function was monitored every 6 hours, and APTT was maintained at 1-1.75 times the upper limit of normal detection until reaching the study endpoints, including 14 days after enrollment, 24 hours after withdrawal from ECMO, or any switch to ECMO mode during ECMO treatment.

Treatment:

Drug: Unfractionated Heparin