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NCT Number: NCT06872021

Early Intra-aortic Balloon Pump Use After Venoarterial Extracorporeal Membrane Oxygenation

The goal of this multicenter, randomized trial is to compare early early left ventricular unloading by Intra-aortic Balloon Pump (IABP) versus conventional approach in patients with cardiogenic shock (CS) undergoing venoarterial extracorporeal membrane oxygenation (VA-ECMO). The main question it aims to answer is :

• If left ventricular unloading by IABP as compared with the conventional approach will improve the outcomes in patients undergoing VA-ECMO.

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Key information

Conditions

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

Xiaotong Hou Hou, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

The role of IABP combined with VA-ECMO in patients with CS remains unclear. Therefore, investigators will conduct a prospective randomized clinical trial to explore the effect of early IABP use for LV unloading after VA-ECMO on outcomes in patients with CS. Investigators will randomly assign 358 patients receiving peripheral VA-ECMO to the ECMO+IABP group (n=179) or the ECMO group (n=179). The primary end point was the 30-day mortality.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age of ≥18
  • Cardiogenic shock(defined as a systolic blood pressure of less than 90 mm Hg for more than 30 minutes or the initiation of catecholamines to maintain a systolic pressure of more than 90 mm Hg, an arterial lactate level of more than 3 mmol per liter, and signs of impaired organ perfusion)
  • Successful implantation of VA-ECMO
  • Informed consent

Exclusion criteria

  • SCAI shock stage A or B
  • Presence of moderate to severe aortic insufficiency or aortic dissection
  • Severe peripheral vascular disease
  • Post-cardiotomy cardiogenic shock(non-CABG procedure) or bridging to cardiac procedure(heart transplantation or LVAD).
  • VA-ECMO for definite non-cardiac causes
  • Isolated right ventricular failure
  • V-A ECMO usage confined to the period during surgery or other interventions
  • Ischemic mechanical complications(eg Ventricular septal defect, papillary muscle rupture)
  • Extracorporeal cardiopulmonary resuscitation
  • LVAD, Impella or IABP in situ.
  • Severe bleeding
  • Terminal malignancy
  • Irreversible neurologic injury
  • Pregnancy or lactation

Treatment and study plan

Early IABP use

Other

Patients receive IABP for left ventricular unloading within 6 hours after VA-ECMO initiation.

Conventional approach

Other

Patients do not receive mechanical unloading within 6 hours after VA-ECMO initiation.

Primary outcomes

  1. 30-day mortality

    Time frame: 30 days

Secondary outcomes

  1. weaning from VA-ECMO

    Time frame: 30 days

  2. Rate of advanced mechanical unloading

    Time frame: 30 days

  3. Left Ventricular Function of survivors

    Time frame: 30 days

  4. In-hospital Mortality

    Time frame: 30 days

  5. Day of Mechanical Circulatory Support Device Weaning

    Time frame: 30 days

  6. Rate of pulmonary congestion on chest X-ray

    Time frame: 30 days

  7. Duration of VA-ECMO

    Time frame: 30 days

  8. Lactate clearance rate at 12 and 24 hours

    Time frame: 30 days

  9. Relative decrease in vasoactive inotropic score(VIS) at 12 and 24 hours

    Time frame: 30 days

    Vasoactive inotropic score (VIS), in µg/kg/min, was calculated as follows: dopamine + dobutamine + 100 epinephrine + 100 norepinephrine + 15×milrinone. Higher VIS predict worse outome.

  10. Reduction in Myocardial Injury Biomarkers (cTnI/cTnT)

    Time frame: 30 days

  11. Reduction in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP)

    Time frame: 30 days

  12. Rate of CRRT

    Time frame: 30 days

  13. Rate of ventricular arrhythmia

    Time frame: 30 days

  14. Rate of stroke

    Time frame: 30 days

  15. Rate of bleeding

    Time frame: 30 days

    BARC type III or V

  16. Rate of limb ischemia

    Time frame: 30 days

    ECMO side/ IABP side

  17. Duration of mechanical ventilation

    Time frame: 30 days

  18. Rate of infection

    Time frame: 30 days

    With or without culture result

  19. ICU length of stay

    Time frame: 30 days

  20. Hospital length of stay

    Time frame: 30 days

Study contacts

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

Xiaotong Hou, MD, PhD

CONTACT

[email protected]

010-64456631

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

Early Intra-aortic Balloon Pump Use After Venoarterial Extracorporeal Membrane Oxygenation: The EASE-ECMO Randomized Clinical Trial

Acronym: EASE-ECMO

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 12, 2025
Registry last updated
Mar 24, 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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