Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO

Not Applicable

Not yet recruiting

• Conditions: Extracorporeal Membrane Oxygenation Complication
• Interventions: Drug: nafamostat mesilate; Drug: unfractionated heparin group

• Registration Number: NCT06276010
• Lead Sponsor: Xiaotong Hou

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.

Detailed Description

Selecting patients who require systemic anticoagulation as the study subjects from patients undergoing extracorporeal membrane oxygenation assistance after cardiac surgery. Randomly divided into the nafamostat mesilate group and unfractionated heparin group. To evaluate the efficacy and safety of nafamostat mesilate by comparing the incidence of bleeding and thrombosis within the target anticoagulant level range between two groups of patients during ECMO

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-16
• Study First Submitted QC: 2024-02-17
• Study First Posted: 2024-02-23
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26
• Study Start: 2024-03-01
• Primary Completion: 2026-03-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nafamostat mesilate group	nafamostat mesilate	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.
unfractionated heparin group	unfractionated heparin group	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 .

Primary Outcome Measures

Name	Time	Method
Incidence of thrombotic complications	Within 7 days after starting anticoagulant therapy	Thrombotic events include loop thrombosis, oxygenator thrombosis, venous thromboembolism, arterial thromboembolism, and cerebral infarction.

Secondary Outcome Measures

Name	Time	Method
Incidence of severe bleeding complications	Within 7 days after starting anticoagulant therapy	The definition of bleeding event refers to ELSO Anticoagulation Guideline.
Infusion volume of blood products	Within 7 days after starting anticoagulant therapy	After randomization, suspended red blood cells, plasma, fibrinogen and platelet volume were infused per person per ECMO day.
ACT qualified rate	Within 7 days after starting anticoagulant therapy	Number of times ACT detection reached the standard / total number of tests during ECMO
Hospitalization mortality	28 days	All-cause mortality
The incidence of oxygenator dysfunction	Within 7 days after starting anticoagulant therapy	incidence
Heparin-induced thrombocytopenia	Within 7 days after starting anticoagulant therapy	incidence
Time to reach the target anticoagulant level for the first time	Within 7 days after starting anticoagulant therapy

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China