Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation

NCT06275555 | Recruiting DMC

• 1 other identifier: 2023-101
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Extracorporeal Membrane Oxygenation Complication

Outcome Measures

Primary Outcomes (2)

• thrombotic complications

  main end point of efficacy

  Within seven days after starting anticoagulant therapy

• bleeding complications

  main safety endpoint

  Within seven days after starting anticoagulant therapy

Secondary Outcomes (7)

• Hospitalization mortality

  28 days

• Loop replacement

  Within seven days after starting anticoagulant therapy

• Infusion volume of blood products

  Within seven days after starting anticoagulant therapy

• Acute renal failure

  Within seven days after starting anticoagulant therapy

• Heparin-induced thrombocytopenia

  Within seven days after starting anticoagulant therapy

Study Arms (2)

bivalirudin group

EXPERIMENTAL

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.

Drug: bivalirudin

unfractionated heparin group

OTHER

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.

Drug: unfractionated heparin

Interventions

bivalirudin DRUG

bivalirudin as an anticoagulant

bivalirudin group

unfractionated heparin DRUG

unfractionated heparin as an anticoagulant

unfractionated heparin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaotong Hou: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Interventions

bivalirudin; Heparin

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Liangshan Wang, MD

  Beijing Anzhen Hospital

  STUDY CHAIR

Central Study Contacts

Xiaotong Hou, MD

CONTACT

010-64456631; xt.hou@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: February 23, 2024
• Study Start: June 3, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)