Clinical trial

Safety and Efficacy of Argatroban Applicated in Anticoagulation of V-V ECMO: A Randomized Controlled Study

Name
Argatroban in V-V ECMO
Description
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.
Trial arms
Trial start
2021-07-06
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Completed
Treatment
Argatroban
Argatroban continuous intravenous injection maintained APTT at 1.5 times of baseline.
Arms:
argatroban group
Other names:
Novastan
unfractionated heparin
unfractionated heparin continuous intravenous injection maintained APTT at 1.5 times of baseline.
Arms:
UFH group
Size
20
Primary endpoint
incidence of ECMO related thrombotic events
14 days
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2024-03-26

1 organization

1 product

1 drug

1 indication

Product
Argatroban