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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
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.
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.
Wuhan Union Hospital
Wuhan, Hubei, China
RECRUITINGIncidence of severe bleeding during ECMO
The ratio of the number of patients with severe bleeding complications to the total number of cases in each group.
Time frame: Up to 14 days.
Incidence of thrombosis during ECMO
The ratio of the number of patients with thrombosis complication to the number of cases in each group.
Time frame: Up to 14 days.
Bleeding-free days during ECMO
Days without bleeding complications
Time frame: Up to 14 days.
Oxygenator replacement frequency
Oxygenator replacement frequency and average number of replacements per patient;
Time frame: Up to 14 days.
The incidence of ECMO dysfunction
The ratio of the number of cases with ECMO dysfunction in each group to the total number of cases.
Time frame: Up to 14 days.
The average amount of red, plasma, cryoprecipitate, fibrinogen, and platelets per person per ECMO day
Average blood transfusion volume per ECMO day, including red blood cells, plasma, cryoprecipitate, fibrinogen, and platelets.
Time frame: Up to 14 days.
The compliance rate of APTT test results
The ratio of the number of APTT tests that met the requirements to the total number of APTT tests during ECMO.
Time frame: Up to 14 days.
Case fatality rate within 28 days
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After follow-up, the fatality rates of all enrolled patients in each group within 28 days of the study began.
Time frame: Up to 28 days.
In-hospital mortality
The fatality rates of all enrolled patients in each group during hospitalization.
Time frame: Through study completion, an average of 2 months.
Average length of ICU stay.
Average number of days in ICU for each group of patients.
Time frame: Through study completion, an average of 2 months.
Average length of hospital stay
The mean of the total hospitalization days for each group of patients
Time frame: Through study completion, an average of 2 months.