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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nafamostat mesilate group | Experimental | 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. |
|
| unfractionated heparin group | Other | 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 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nafamostat mesilate | Drug | Use nafamostat mesilate as an anticoagulant |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaotong Hou, MD | Contact | 010-64456631 | xt.hou@ccmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhongtao Du, MD | Beijing Anzhen Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| C032855 | nafamostat |
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| unfractionated heparin group |
| Drug |
Use unfractionated heparin as an anticoagulant |
|
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 |