A Novel Strategy of ECMO Management Using Nafamostat for Regional Combined With Low Intensity Systematic Anticoagulation

Capital Medical University

Status: Enrolling

Conditions: ECMO

Treatments: Drug: Nafamostat; Drug: Heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT06676085

Nafamostat in ECMO

Details and patient eligibility

About

ECMO is widely used in patients with refractory respiratory and/or circulatory failure.The data shows that the incidence of bleeding and thrombotic events is still above 40%,and it is closely related to the increase in mortality rate.Therefore, optimizing ECMO anticoagulation management to reduce bleeding and thrombotic events is a key scientific issue that urgently needs to be addressed.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age older than 18 years old
• received ECMO because of severe respiratory failure

Exclusion criteria

• anticoagulant contraindications
• cerebral infarction or suspected patients
• severe hypertension
• women in gestational and lactational period
• hemophilia
• allergic to heparin or Nafamostat
• unwilling or unable to complete the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

New Anticoagulation Strategy Group

Experimental group

Description:

Combination of nafamostat and unfractionated heparin for anticoagulation, adjusting the dosage of unfractionated heparin to maintain APTT in the body for 40-45 seconds, and adjusting the dosage of nafamostat to maintain APTT in the membranous lung for 50-60 seconds during ECMO

Treatment:

Drug: Nafamostat

control group

Active Comparator group

Description:

Anticoagulation with unfractionated heparin, regulating the dosage of unfractionated heparin to maintain APTT in the body for 50-60s during ECMO.

Treatment:

Drug: Heparin