Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: bivalirudin, unfractionated heparin.
- Who it may be relevant to
- Registry conditions: Extracorporeal Membrane Oxygenation Complication. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Bivalirudin Versus Heparin in Anticoagulant Therapy of ECMO: a Randomized Controlled Trial
Overview
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
- Drug bivalirudin
bivalirudin as an anticoagulant - Drug unfractionated heparin
unfractionated heparin as an anticoagulant
Primary outcome measures
- thrombotic complications [Time frame: Within seven days after starting anticoagulant therapy]
- bleeding complications [Time frame: Within seven days after starting anticoagulant therapy]
Secondary outcome measures (7)
- Hospitalization mortality [Time frame: 28 days]
- Loop replacement [Time frame: Within seven days after starting anticoagulant therapy]
- Infusion volume of blood products [Time frame: Within seven days after starting anticoagulant therapy]
- Acute renal failure [Time frame: Within seven days after starting anticoagulant therapy]
- Heparin-induced thrombocytopenia [Time frame: Within seven days after starting anticoagulant therapy]
- the time of reaching the target anticoagulant level for the first time [Time frame: Within seven days after starting anticoagulant therapy]
- Percentage of time during ECMO within the target anticoagulant level [Time frame: Within seven days after starting anticoagulant therapy]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years old
- Accept VA-ECMO or VV-ECMO
- the ECMO team believes that systemic anticoagulation is necessary and that APTT should be maintained at 40-60s.
- sign the informed consent form
Exclusion criteria
- previous history of allergy to heparin or bivalirudin
- previous diagnosis of heparin-induced thrombocytopenia.
- the pre-random ECMO assistance time is more than 48 hours.
- pregnant female
- have participated in this study before.
- the researchers believe that there are other factors that are not suitable to participate in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
China · 1 center
- Beijing Anzhen Hospital — Beijing
Identifiers
NCT: NCT06275555 · 2023-101