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Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO

ConditionExtracorporeal Membrane Oxygenation Complication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXiaotong Hou

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • nafamostat mesilate

    Drug

    Use nafamostat mesilate as an anticoagulant

  • unfractionated heparin group

    Drug

    Use unfractionated heparin as an anticoagulant

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: nafamostat mesilate groupExperimental treatment 1 intervention
Group B: unfractionated heparin groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of thrombotic complications

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

Time frame
Within 7 days after starting anticoagulant therapy

Secondary outcomes

1

Incidence of severe bleeding complications

The definition of bleeding event refers to ELSO Anticoagulation Guideline.

Time frame
Within 7 days after starting anticoagulant therapy
2

Infusion volume of blood products

After randomization, suspended red blood cells, plasma, fibrinogen and platelet volume were infused per person per ECMO day.

Time frame
Within 7 days after starting anticoagulant therapy
3

ACT qualified rate

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

Time frame
Within 7 days after starting anticoagulant therapy
4

Hospitalization mortality

All-cause mortality

Time frame
28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiaotong Hou

Lead sponsor

Beijing Anzhen Hospital

Sponsor institution

Source ClinicalTrials.gov
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