Clinical trial
Efficacy and Safety of Bivalirudin Versus Heparin in Anticoagulant Therapy of ECMO: a Randomized Controlled Trial
Name
2023-101
Description
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.
Trial arms
Trial start
2024-03-01
Estimated PCD
2025-03-01
Trial end
2025-12-31
Status
Not yet recruiting
Treatment
bivalirudin
bivalirudin as an anticoagulant
Arms:
bivalirudin group
unfractionated heparin
unfractionated heparin as an anticoagulant
Arms:
unfractionated heparin group
Size
154
Primary endpoint
thrombotic complications
Within seven days after starting anticoagulant therapy
bleeding complications
Within seven days after starting anticoagulant therapy
Eligibility criteria
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 50-70s.
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 154, 'type': 'ESTIMATED'}}
Updated at
2024-02-26
1 organization
1 product
1 drug
1 indication
Organization
Xiaotong HouProduct
bivalirudin