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The purpose of this study was to evaluate the efficacy and safety of bivalirudin in anticoagulation therapy in patients with extracorporeal membrane oxygenation (ECMO) compared with unfractionated heparin.
Patients with ECMO who needed systemic anticoagulation were randomly divided into bivalirudin group and unfractionated heparin group;the efficacy of bivalirudin in ECMO anticoagulation was evaluated by comparing the percentage of time within the target anticoagulation level and the incidence of thrombotic complications between the two groups during ECMO; and the safety of bivalirudin in ECMO anticoagulation was evaluated by comparing bleeding complications, blood product infusion and the incidence of acute renal failure between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bivalirudin group | Experimental | If the creatinine clearance rate > 30ml/min, the initial dose of bivalirudin is 0.04mg/kg/h. If the creatinine clearance rate<30ml/min or the patients who have received renal replacement therapy (CRRT), the initial dose of bivalirudin is 0.02mg/kg/h, and the dose is adjusted according to APPT to maintain APTT at 40-60s. After bivalirudin started, APTT was checked every 4 hours. If APTT was in the target range twice in a row, it was re-examined every 12 hours. |
|
| unfractionated heparin group | Other | The initial dose of heparin was 8-12U/kg/h, and the dosage of heparin was adjusted according to the value of APTT. APTT was maintained at 40-60s, and APTT was reexamined every 4 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bivalirudin | Drug | bivalirudin as an anticoagulant |
| |
| Measure | Description | Time Frame |
|---|---|---|
| thrombotic complications | main end point of efficacy | Within seven days after starting anticoagulant therapy |
| bleeding complications | main safety endpoint | Within seven days after starting anticoagulant therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization mortality | All-cause death | 28 days |
| Loop replacement | Within seven days after starting anticoagulant therapy | |
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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 |
|---|---|---|
| Liangshan Wang, 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 |
|---|---|
| C074619 | bivalirudin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| unfractionated heparin |
| Drug |
unfractionated heparin as an anticoagulant |
|
| Infusion volume of blood products |
Plasma, platelets and red blood cells |
| Within seven days after starting anticoagulant therapy |
| Acute renal failure | Incidence rate | Within seven days after starting anticoagulant therapy |
| Heparin-induced thrombocytopenia | Incidence rate | Within seven days after starting anticoagulant therapy |
| the time of reaching the target anticoagulant level for the first time | Within seven days after starting anticoagulant therapy |
| Percentage of time during ECMO within the target anticoagulant level | APTT maintained at 40-60s | Within seven days after starting anticoagulant therapy |