Clinical trial
Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation: a Randomized, Single-blind, Multicenter Exploratory, Heparin-controlled Trial
Name
NMST20211022
Description
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.
Trial arms
Trial start
2022-12-20
Estimated PCD
2024-10-01
Trial end
2024-10-01
Status
Recruiting
Phase
Early phase I
Treatment
Nafamostat Mesylate
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.
Arms:
Nafamostat Mesylate
Unfractionated Heparin
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.
Arms:
Unfractionated Heparin
Size
40
Primary endpoint
Incidence of severe bleeding during ECMO
Up to 14 days.
Eligibility criteria
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;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-02-15
1 organization
2 products
2 indications
Organization
Xiaobo Yang, MDProduct
NafamostatIndication
Critical IllnessIndication
Anticoagulant therapyProduct
Unfractionated Heparin