Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation

NCT05555641 | Unknown Phase 2

• 1 other identifier: NMST20211022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Anticoagulation

Keywords

Extracorporeal Membrane Oxygenation; Nafamostat mesylate; Unfractionated heparin; Anticoagulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Incidence of thrombosis during ECMO

  Up to 14 days.

• Bleeding-free days during ECMO

  Up to 14 days.

• Oxygenator replacement frequency

  Up to 14 days.

• The incidence of ECMO dysfunction

  Up to 14 days.

• The average amount of red, plasma, cryoprecipitate, fibrinogen, and platelets per person per ECMO day

  Up to 14 days.

Study Arms (2)

Nafamostat Mesylate

EXPERIMENTAL

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.

Drug: Nafamostat Mesylate

Unfractionated Heparin

ACTIVE COMPARATOR

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.

Drug: Unfractionated Heparin

Interventions

Nafamostat Mesylate 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.

Nafamostat Mesylate

Unfractionated Heparin 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.

Unfractionated Heparin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xiaobo Yang, MD: lead

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Critical Illness

Interventions

nafamostat; Heparin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

You Shang, Prof.

CONTACT

008602785351607; you_shanghust@163.com

Xiaobo Yang, Prof.

CONTACT

008602785351606; want.tofly@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 27, 2022
• Study Start: December 20, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

CN (1)