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

Not Applicable

Recruiting

• Conditions: ECMO
• Interventions: Drug: Nafamostat; Drug: Heparin

• Registration Number: NCT06676085
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-11-01
• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-04
• Study First Posted: 2024-11-06
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New Anticoagulation Strategy Group	Nafamostat	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
control group	Heparin	Anticoagulation with unfractionated heparin, regulating the dosage of unfractionated heparin to maintain APTT in the body for 50-60s during ECMO.

Primary Outcome Measures

Name	Time	Method
incidence of ECMO related bleeding or thrombotic events	28 days	the incidence of ECMO related bleeding or thrombotic events,such as membrane oxygenator or tube thrombotic,local blooding.

Trial Locations

Locations (1)

Bing Sun; 🇨🇳 Beijing, Beijing, China