Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO

NCT06276010 | Recruiting DMC

• 1 other identifier: 2023-102
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of nafamostat mesilate compared with unfractionated heparin for anticoagulation in patients with ECMO after cardiac surgery.

Conditions

Extracorporeal Membrane Oxygenation Complication

Keywords

anticoagulation; nafamostat mesilate

Outcome Measures

Primary Outcomes (1)

• Incidence of thrombotic complications

  Thrombotic events include loop thrombosis, oxygenator thrombosis, venous thromboembolism, arterial thromboembolism, and cerebral infarction.

  Within 7 days after starting anticoagulant therapy

Secondary Outcomes (7)

• Incidence of severe bleeding complications

  Within 7 days after starting anticoagulant therapy

• Infusion volume of blood products

  Within 7 days after starting anticoagulant therapy

• ACT qualified rate

  Within 7 days after starting anticoagulant therapy

• Hospitalization mortality

  28 days

• The incidence of oxygenator dysfunction

  Within 7 days after starting anticoagulant therapy

Study Arms (2)

nafamostat mesilate group

EXPERIMENTAL

The initial dosing of the nafamostat mesilate group is 0.5mg/kg/h. We maintain ACT at 180\~220s by adjusting the dosage of nafamostat mesilate.

Drug: nafamostat mesilate

unfractionated heparin group

OTHER

The initial dosing of the unfractionated heparin group is 8\~12U/kg/h. We maintain ACT at 180\~220s by adjusting the dosage of unfractionated heparin .

Drug: unfractionated heparin group

Interventions

nafamostat mesilate DRUG

Use nafamostat mesilate as an anticoagulant

nafamostat mesilate group

unfractionated heparin group DRUG

Use unfractionated heparin as an anticoagulant

unfractionated heparin group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old
• VA-ECMO or VV-ECMO was accepted after cardiac surgery.
• The ECMO treatment team believes that systemic anticoagulation is needed
• Sign the informed consent form

You may not qualify if:

• The researchers believe that there are other causes of active bleeding that are not suitable to participate in this study.
• Long-term use of anticoagulants before establishment of ECMO
• Antiplatelet drugs were used before the establishment of ECMO
• Severe liver insufficiency
• Connective tissue disease
• There is a history of allergy to heparin or nemolastat mesylate.
• Pregnant
• Previous diagnosis of heparin-induced thrombocytopenia
• Expect to die within 48 hours
• ECPR

Sponsors & Collaborators

• Xiaotong Hou: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Interventions

nafamostat

Study Officials

• Zhongtao Du, MD

  Beijing Anzhen Hospital

  STUDY CHAIR

Central Study Contacts

Xiaotong Hou, MD

CONTACT

010-64456631; xt.hou@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 23, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)