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NCT Number: NCT06275555

Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location status: Recruiting

Location contact

Liangshan Wang, MD

CONTACT

[email protected]

86-13811363372

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bivalirudin

Drug

bivalirudin as an anticoagulant

Unfractionated heparin

Drug

unfractionated heparin as an anticoagulant

Primary outcomes

  1. thrombotic complications

    Time frame: Within seven days after starting anticoagulant therapy

    main end point of efficacy

  2. bleeding complications

    Time frame: Within seven days after starting anticoagulant therapy

    main safety endpoint

Secondary outcomes

  1. Hospitalization mortality

    Time frame: 28 days

    All-cause death

  2. Loop replacement

    Time frame: Within seven days after starting anticoagulant therapy

  3. Infusion volume of blood products

    Time frame: Within seven days after starting anticoagulant therapy

    Plasma, platelets and red blood cells

  4. Acute renal failure

    Time frame: Within seven days after starting anticoagulant therapy

    Incidence rate

  5. Heparin-induced thrombocytopenia

    Time frame: Within seven days after starting anticoagulant therapy

    Incidence rate

  6. the time of reaching the target anticoagulant level for the first time

    Time frame: Within seven days after starting anticoagulant therapy

  7. Percentage of time during ECMO within the target anticoagulant level

    Time frame: Within seven days after starting anticoagulant therapy

    APTT maintained at 40-60s

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaotong Hou, MD

CONTACT

[email protected]

010-64456631

Sponsors and collaborators

Lead sponsor

Xiaotong Hou

Other

Registry information

Official study title

Efficacy and Safety of Bivalirudin Versus Heparin in Anticoagulant Therapy of ECMO: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 23, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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