Clinical trial NCT06275555: Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation
Official title: Efficacy and Safety of Bivalirudin Versus Heparin in Anticoagulant Therapy of ECMO: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Extracorporeal Membrane Oxygenation Complication
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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 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.

Primary outcomes:
measure: thrombotic complications
timeFrame: Within seven days after starting anticoagulant therapy
measure: bleeding complications
timeFrame: Within seven days after starting anticoagulant therapy
Secondary outcomes:
measure: Hospitalization mortality
timeFrame: 28 days
measure: Loop replacement
timeFrame: Within seven days after starting anticoagulant therapy
measure: Infusion volume of blood products
timeFrame: Within seven days after starting anticoagulant therapy
measure: Acute renal failure
timeFrame: Within seven days after starting anticoagulant therapy
measure: Heparin-induced thrombocytopenia
timeFrame: Within seven days after starting anticoagulant therapy
measure: the time of reaching the target anticoagulant level for the first time
timeFrame: Within seven days after starting anticoagulant therapy
measure: Percentage of time during ECMO within the target anticoagulant level
timeFrame: Within seven days after starting anticoagulant therapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Liangshan Wang, MD
role: STUDY_CHAIR
References: