Clinical trial NCT05555641: Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation
Official title: Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation: a Randomized, Single-blind, Multicenter Exploratory, Heparin-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Critical Illness
Anticoagulation
Keywords: Extracorporeal Membrane Oxygenation
Nafamostat mesylate
Unfractionated heparin
Anticoagulation
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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;

Primary outcomes:
measure: Incidence of severe bleeding during ECMO
timeFrame: Up to 14 days.
Secondary outcomes:
measure: Incidence of thrombosis during ECMO
timeFrame: Up to 14 days.
measure: Bleeding-free days during ECMO
timeFrame: Up to 14 days.
measure: Oxygenator replacement frequency
timeFrame: Up to 14 days.
measure: The incidence of ECMO dysfunction
timeFrame: Up to 14 days.
measure: The average amount of red, plasma, cryoprecipitate, fibrinogen, and platelets per person per ECMO day
timeFrame: Up to 14 days.
measure: The compliance rate of APTT test results
timeFrame: Up to 14 days.
measure: Case fatality rate within 28 days
timeFrame: Up to 28 days.
measure: In-hospital mortality
timeFrame: Through study completion, an average of 2 months.
measure: Average length of ICU stay.
timeFrame: Through study completion, an average of 2 months.
measure: Average length of hospital stay
timeFrame: Through study completion, an average of 2 months.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
Study officials:
References: