Respiratory Failure
Conditions
Brief summary
Unfractionated heparin is most common in the anticoagulation management of V-V ECMO. However, many side effects of unfractionated heparin, such as HIT, antithrombin deficiency, etc seriously affects the prognosis of patients. Argatroban is kind of direct thrombin inhibitors, which could be used used as an alternative anticoagulant of unfractionated heparin when HIT or antithrombin deficiency, etc. At present, there is no power enough evidence for the application of argatroban in V-V ECMO. This study aims to evaluat the safety and effectiveness of argatroban in the anticoagulation management of V-V ECMO compared with unfractionated heparin.
Interventions
DRUGArgatroban
Argatroban continuous intravenous injection maintained APTT at 1.5 times of baseline.
DRUGunfractionated heparin
unfractionated heparin continuous intravenous injection maintained APTT at 1.5 times of baseline.
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age older than 18 years old; received V-V ECMO because of sevever respiratory failure
Exclusion criteria
* anticoagulant contraindications; Confirmed or suspected, or previously diagnosed with heparin induced thrombocytopenia; Cerebral infarction or suspected patients; Patients with severe liver dysfunction; Allergic to heparin or argatroban; hemophilia; Unwilling or unable to complete the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of ECMO related thrombotic events | 14 days | the incidence of ECMO related thrombotic events, such as membrane oxygenator or tube thrombosis. |
Countries
China
Outcome results
None listed