Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO

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

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.

Study Overview

• Status: Recruiting
• Conditions: Extracorporeal Membrane Oxygenation Complication
• Intervention / Treatment: Drug: nafamostat mesilate; Drug: unfractionated heparin group

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaotong Hou, MD; Phone Number: 010-64456631; Email: xt.hou@ccmu.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Recruiting
      • Beijing Anzhen Hospital
      • Contact: Zhongtao Du, MD; Phone Number: 86-18610846901; Email: zhongtaodu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nafamostat mesilate group; 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; Use nafamostat mesilate as an anticoagulant
Other: 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 .	Drug: unfractionated heparin group; Use unfractionated heparin as an anticoagulant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of severe bleeding complications	The definition of bleeding event refers to ELSO Anticoagulation Guideline.	Within 7 days after starting anticoagulant therapy
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
ACT qualified rate	Number of times ACT detection reached the standard / total number of tests during ECMO	Within 7 days after starting anticoagulant therapy
Hospitalization mortality	All-cause mortality	28 days
The incidence of oxygenator dysfunction	incidence	Within 7 days after starting anticoagulant therapy
Heparin-induced thrombocytopenia	incidence	Within 7 days after starting anticoagulant therapy
Time to reach the target anticoagulant level for the first time		Within 7 days after starting anticoagulant therapy

Collaborators and Investigators

• Sponsor: Xiaotong Hou
• Investigators: Study Chair: Zhongtao Du, MD, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: February 17, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: anticoagulation; nafamostat mesilate
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Immunosuppressive Agents; Immunologic Factors; Protease Inhibitors; Serine Proteinase Inhibitors; Anticoagulants; Trypsin Inhibitors; Complement Inactivating Agents; nafamostat
• Other Study ID Numbers: 2023-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No