Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation

Phase 2

Recruiting

• Conditions: Critical Illness; Anticoagulation
• Interventions: Drug: Nafamostat Mesylate; Drug: Unfractionated Heparin

• Registration Number: NCT05555641
• Lead Sponsor: Xiaobo Yang, MD

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.

Study Timeline

• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-27
• Study Start: 2022-12-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-11
• Last Update Posted: 2023-02-15
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nafamostat Mesylate	Nafamostat Mesylate	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.
Unfractionated Heparin	Unfractionated Heparin	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
Bleeding-free days during ECMO	Up to 14 days.	Days without bleeding complications
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.
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 hospital stay	Through study completion, an average of 2 months.	The mean of the total hospitalization days for each group of patients
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.
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.
Average length of ICU stay.	Through study completion, an average of 2 months.	Average number of days in ICU for each group of patients.

Trial Locations

Locations (1)

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China