CClinicalTrials.gg
Sign In
RecruitingNCT06872021EASE-ECMOUpdated Mar 24, 2026

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

An interventional study of Early IABP use and Conventional approach in ECMO, sponsored by Beijing Anzhen Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by Beijing Anzhen Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
358
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.
Read the detailed description

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.

02

Conditions studied

  • ECMO

Keywords

  • ECMO
  • IABP
  • LV unloading
03

In context

Lead sponsor

Beijing Anzhen Hospital is the lead sponsor of 188 studies on the registry; 100 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age of ≥18
  2. 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)
  3. Successful implantation of VA-ECMO
  4. Informed consent

Exclusion criteria

Exclusion Criteria:

  1. SCAI shock stage A or B
  2. Presence of moderate to severe aortic insufficiency or aortic dissection
  3. Severe peripheral vascular disease
  4. Post-cardiotomy cardiogenic shock(non-CABG procedure) or bridging to cardiac procedure(heart transplantation or LVAD).
  5. VA-ECMO for definite non-cardiac causes
  6. Isolated right ventricular failure
  7. V-A ECMO usage confined to the period during surgery or other interventions
  8. Ischemic mechanical complications(eg Ventricular septal defect, papillary muscle rupture)
  9. Extracorporeal cardiopulmonary resuscitation
  10. LVAD, Impella or IABP in situ.
  11. Severe bleeding
  12. Terminal malignancy
  13. Irreversible neurologic injury
  14. Pregnancy or lactation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
358 participants (estimated)

Study arms

  • Experimental
    ECMO+IABP group

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

    Other: Early IABP use

  • Active comparator
    ECMO group

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

    Other: Conventional approach

Interventions

  • OtherEarly IABP use

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

  • OtherConventional approach

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

06

What researchers measure

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

    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.

    Time frame: 30 days

  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

    BARC type III or V

    Time frame: 30 days

  16. Rate of limb ischemia

    ECMO side/ IABP side

    Time frame: 30 days

  17. Duration of mechanical ventilation

    Time frame: 30 days

  18. Rate of infection

    With or without culture result

    Time frame: 30 days

  19. ICU length of stay

    Time frame: 30 days

  20. Hospital length of stay

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
  • Beijing Anzhen Hospital
    Beijing, Beijing Municipality 100029, China
    • Liangshan Wang, MD · Contact · wangliangshanbam@sina.com · 86-13811363372
    • Xiaotong Hou Hou, MD, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06872021
Lead sponsor
Beijing Anzhen Hospital
Responsible party
Xiaotong Hou (Professor, Beijing Anzhen Hospital) — Principal investigator
First posted
Mar 12, 2025
Start date
Mar 22, 2026
Primary completion
Sep 1, 2028 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Mar 24, 2026

Study contacts

Xiaotong Hou, MD, PhD
Contact
xt.hou@ccmu.edu.cn
010-64456631
Xiaotong Hou, MD, PhD
principal investigator · Beijing Anzhen Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Beijing Anzhen Hospital

Start the discussion