Extracorporeal Membrane Oxygenation Complication
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGbivalirudin
bivalirudin as an anticoagulant
DRUGunfractionated heparin
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. Accept VA-ECMO or VV-ECMO 3. the ECMO team believes that systemic anticoagulation is necessary and that APTT should be maintained at 40-60s. 4. sign the informed consent form
Exclusion criteria
1. previous history of allergy to heparin or bivalirudin 2. previous diagnosis of heparin-induced thrombocytopenia. 3. the pre-random ECMO assistance time is more than 48 hours. 4. pregnant female 5. have participated in this study before. 6. the researchers believe that there are other factors that are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| thrombotic complications | Within seven days after starting anticoagulant therapy | main end point of efficacy |
| bleeding complications | Within seven days after starting anticoagulant therapy | main safety endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization mortality | 28 days | All-cause death |
| Loop replacement | Within seven days after starting anticoagulant therapy | — |
| Infusion volume of blood products | Within seven days after starting anticoagulant therapy | Plasma, platelets and red blood cells |
| Acute renal failure | Within seven days after starting anticoagulant therapy | Incidence rate |
| Heparin-induced thrombocytopenia | Within seven days after starting anticoagulant therapy | Incidence rate |
| 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 | Within seven days after starting anticoagulant therapy | APTT maintained at 40-60s |
Countries
China
Contacts
CONTACTXiaotong Hou, MD
STUDY_CHAIRLiangshan Wang, MD
Beijing Anzhen Hospital
Outcome results
None listed