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NCT Number: NCT06276010

Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location status: Recruiting

Location contact

Zhongtao Du, MD

CONTACT

[email protected]

86-18610846901

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Nafamostat Mesilate

Drug

Use nafamostat mesilate as an anticoagulant

unfractionated heparin group

Drug

Use unfractionated heparin as an anticoagulant

Primary outcomes

  1. Incidence of thrombotic complications

    Time frame: Within 7 days after starting anticoagulant therapy

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

Secondary outcomes

  1. Incidence of severe bleeding complications

    Time frame: Within 7 days after starting anticoagulant therapy

    The definition of bleeding event refers to ELSO Anticoagulation Guideline.

  2. Infusion volume of blood products

    Time frame: 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.

  3. ACT qualified rate

    Time frame: Within 7 days after starting anticoagulant therapy

    Number of times ACT detection reached the standard / total number of tests during ECMO

  4. Hospitalization mortality

    Time frame: 28 days

    All-cause mortality

  5. The incidence of oxygenator dysfunction

    Time frame: Within 7 days after starting anticoagulant therapy

    incidence

  6. Heparin-induced thrombocytopenia

    Time frame: Within 7 days after starting anticoagulant therapy

    incidence

  7. Time to reach the target anticoagulant level for the first time

    Time frame: Within 7 days after starting anticoagulant therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaotong Hou, MD

CONTACT

[email protected]

010-64456631

Sponsors and collaborators

Lead sponsor

Xiaotong Hou

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2024
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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