Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation

Xiaotong Hou

Status: Not yet enrolling

Conditions: Extracorporeal Membrane Oxygenation Complication

Treatments: Drug: unfractionated heparin; Drug: bivalirudin

Study type: Interventional

Funder types: Other

Identifiers

NCT06275555

2023-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

bivalirudin group

Experimental group

Description:

If the creatinine clearance rate \> 30ml/min, the initial dose of bivalirudin is 0.04mg/kg/h. If the creatinine clearance rate\<30ml/min or the patients who have received renal replacement therapy (CRRT), the initial dose of bivalirudin is 0.02mg/kg/h, and the dose is adjusted according to APPT to maintain APTT at 40-60s. After bivalirudin started, APTT was checked every 4 hours. If APTT was in the target range twice in a row, it was re-examined every 12 hours.

Treatment:

Drug: bivalirudin

unfractionated heparin group

Other group

Description:

The initial dose of heparin was 8-12U/kg/h, and the dosage of heparin was adjusted according to the value of APTT. APTT was maintained at 40-60s, and APTT was reexamined every 4 hours.

Treatment:

Drug: unfractionated heparin