Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555641
• Other study ID #: NMST20211022
• Status: Recruiting
• Phase: Phase 2
• Start date: December 20, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2023
• Source: Wuhan Union Hospital, China
• Contact: You Shang, Prof.
• Phone: 008602785351607
• Email: you_shanghust[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Anticoagulation
• Critical Illness

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Wuhan Union Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Xiaobo Yang, MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence 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.	Up to 14 days.
Secondary	Incidence of thrombosis during ECMO	The ratio of the number of patients with thrombosis complication to the number of cases in each group.	Up to 14 days.
Secondary	Bleeding-free days during ECMO	Days without bleeding complications	Up to 14 days.
Secondary	Oxygenator replacement frequency	Oxygenator replacement frequency and average number of replacements per patient;	Up to 14 days.
Secondary	The incidence of ECMO dysfunction	The ratio of the number of cases with ECMO dysfunction in each group to the total number of cases.	Up to 14 days.
Secondary	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.	Up to 14 days.
Secondary	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.	Up to 14 days.
Secondary	Case fatality rate within 28 days	After follow-up, the fatality rates of all enrolled patients in each group within 28 days of the study began.	Up to 28 days.
Secondary	In-hospital mortality	The fatality rates of all enrolled patients in each group during hospitalization.	Through study completion, an average of 2 months.
Secondary	Average length of ICU stay.	Average number of days in ICU for each group of patients.	Through study completion, an average of 2 months.
Secondary	Average length of hospital stay	The mean of the total hospitalization days for each group of patients	Through study completion, an average of 2 months.