Extracorporeal Membrane Oxygenation Complication
Conditions
Keywords
anticoagulation, nafamostat mesilate
Brief summary
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.
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
Interventions
Use nafamostat mesilate as an anticoagulant
DRUGunfractionated heparin group
Use unfractionated heparin as an anticoagulant
Sponsors
Xiaotong Hou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of thrombotic complications | Within 7 days after starting anticoagulant therapy | Thrombotic events include loop thrombosis, oxygenator thrombosis, venous thromboembolism, arterial thromboembolism, and cerebral infarction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infusion volume of blood products | 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. |
| ACT qualified rate | Within 7 days after starting anticoagulant therapy | Number of times ACT detection reached the standard / total number of tests during ECMO |
| Hospitalization mortality | 28 days | All-cause mortality |
| Incidence of severe bleeding complications | Within 7 days after starting anticoagulant therapy | The definition of bleeding event refers to ELSO Anticoagulation Guideline. |
| Heparin-induced thrombocytopenia | Within 7 days after starting anticoagulant therapy | incidence |
| Time to reach the target anticoagulant level for the first time | Within 7 days after starting anticoagulant therapy | — |
| The incidence of oxygenator dysfunction | Within 7 days after starting anticoagulant therapy | incidence |
Countries
China
Contacts
Primary ContactXiaotong Hou, MD
Outcome results
None listed