Efficacy and Safety of Nafamostat Mesylate for ECMO Anticoagulation

Sponsor

Wuhan Union Hospital, China (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05555641

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness Anticoagulation	Drug: Nafamostat Mesylate Drug: Unfractionated Heparin	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Nafamostat Mesylate for ECMO Anticoagulation: a Randomized, Single-blind, Multicenter Exploratory, Heparin-controlled Trial

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nafamostat Mesylate ECMO patients were given continuous anticoagulation with nafamostat mesylate, coagulation function was monitored every 4 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.	Drug: Nafamostat Mesylate ECMO patients were given continuous anticoagulation with nafamostat mesylate, coagulation function was monitored every 4 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.
Active Comparator: Unfractionated Heparin ECMO patients were given continuous anticoagulation with unfractionated heparin, coagulation function was monitored every 4 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.	Drug: Unfractionated Heparin ECMO patients were given continuous anticoagulation with unfractionated heparin, coagulation function was monitored every 4 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.

Arm

Intervention/Treatment

Experimental: Nafamostat Mesylate

ECMO patients were given continuous anticoagulation with nafamostat mesylate, coagulation function was monitored every 4 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.

Drug: Nafamostat Mesylate

Active Comparator: Unfractionated Heparin

ECMO patients were given continuous anticoagulation with unfractionated heparin, coagulation function was monitored every 4 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.

Drug: Unfractionated Heparin

Outcome Measures

Primary Outcome Measures

Incidence of severe bleeding during ECMO [Up to 14 days.]
The ratio of the number of patients with severe bleeding complications to the total number of cases in each group.

Secondary Outcome Measures

Incidence of thrombosis during ECMO [Up to 14 days.]
The ratio of the number of patients with thrombosis complication to the number of cases in each group.
Bleeding-free days during ECMO [Up to 14 days.]
Days without bleeding complications
Oxygenator replacement frequency [Up to 14 days.]
Oxygenator replacement frequency and average number of replacements per patient;
The incidence of ECMO dysfunction [Up to 14 days.]
The ratio of the number of cases with ECMO dysfunction in each group to the total number of cases.
The average amount of red, plasma, cryoprecipitate, fibrinogen, and platelets per person per ECMO day [Up to 14 days.]
Average blood transfusion volume per ECMO day, including red blood cells, plasma, cryoprecipitate, fibrinogen, and platelets.
The compliance rate of APTT test results [Up to 14 days.]
The ratio of the number of APTT tests that met the requirements to the total number of APTT tests during ECMO.
Case fatality rate within 28 days [Up to 28 days.]
After follow-up, the fatality rates of all enrolled patients in each group within 28 days of the study began.
In-hospital mortality [Through study completion, an average of 2 months.]
The fatality rates of all enrolled patients in each group during hospitalization.
Average length of ICU stay. [Through study completion, an average of 2 months.]
Average number of days in ICU for each group of patients.
Average length of hospital stay [Through study completion, an average of 2 months.]
The mean of the total hospitalization days for each group of patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;