Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO

Extracorporeal Membrane Oxygenation Complication Clinical Trial

Official title:

Use of Nafamostat Mesilate for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation After Cardiac Surgery: Efficacy and Safety

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06276010
• Other study ID #: 2023-102
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Beijing Anzhen Hospital
• Contact: Xiaotong Hou, MD
• Phone: 010-64456631
• Email: xt.hou[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation Complication

Intervention

Drug:
• nafamostat mesilate
Use nafamostat mesilate as an anticoagulant
• unfractionated heparin group
Use unfractionated heparin as an anticoagulant

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xiaotong Hou

Country where clinical trial is conducted

China, 

Outcome

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