Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation

NCT ID: NCT05555641

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-20
• Study Completion Date: 2024-10-01

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.

Conditions

Critical Illness; Anticoagulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Nafamostat Mesylate

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Unfractionated Heparin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiaobo Yang, MD

OTHER

Sponsor Role: lead

Responsible Party

Xiaobo Yang, MD

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Wuhan Union Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

You Shang, Prof.

Role: CONTACT

you_shanghust@163.com

008602785351607

Xiaobo Yang, Prof.

Role: CONTACT

want.tofly@aliyun.com

008602785351606

Facility Contacts

Xuehui Gao

Role: primary

2542907921@qq.com

13681540930

Other Identifiers

NMST20211022

Identifier Type: -

Identifier Source: org_study_id