Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO

Xiaotong Hou80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Extracorporeal Membrane Oxygenation Complication

Interventions

nafamostat mesilateDRUG

Use nafamostat mesilate as an anticoagulant

unfractionated heparin groupDRUG

Use unfractionated heparin as an anticoagulant

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Incidence of thrombotic complications

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