Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation

NCT ID: NCT06275555

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2026-12-31

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.

Conditions

Extracorporeal Membrane Oxygenation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

bivalirudin group

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.

Group Type: EXPERIMENTAL

bivalirudin

Intervention Type: DRUG

bivalirudin as an anticoagulant

unfractionated heparin group

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.

Group Type: OTHER

unfractionated heparin

Intervention Type: DRUG

unfractionated heparin as an anticoagulant

Interventions

bivalirudin

bivalirudin as an anticoagulant

Intervention Type: DRUG

unfractionated heparin

unfractionated heparin as an anticoagulant

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiaotong Hou

OTHER

Sponsor Role: lead

Responsible Party

Xiaotong Hou

Clinical professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Liangshan Wang, MD

Role: STUDY_CHAIR

Beijing Anzhen Hospital

Locations

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaotong Hou, MD

Role: CONTACT

xt.hou@ccmu.edu.cn

010-64456631

Facility Contacts

Liangshan Wang, MD

Role: primary

wangliangshanbam@sina.com

86-13811363372

Other Identifiers

2023-101

Identifier Type: -

Identifier Source: org_study_id