Early intra-aortic balloon pump (IABP) use after venoarterial ECMO for cardiogenic shock

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

This test will see if adding an intra-aortic balloon pump (IABP) soon after starting VA-ECMO helps adults with cardiogenic shock survive and recover better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 358 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06872021 on ClinicalTrials.gov

What this trial studies

This prospective, randomized trial will enroll 358 adults with cardiogenic shock who have had successful peripheral VA-ECMO implantation and randomly assign them to early IABP plus ECMO or to conventional ECMO care alone. The primary outcome is 30-day mortality, with secondary clinical outcomes tracked during follow-up. Key exclusions include moderate-to-severe aortic insufficiency or aortic dissection, severe peripheral vascular disease, isolated right ventricular failure, non-cardiac indications for ECMO, and prior use of other mechanical circulatory supports. The parallel-group design aims to generate controlled evidence on whether early left ventricular unloading with IABP improves outcomes compared with standard management.

Who should consider this trial

Good fit: Adults (≥18 years) in cardiogenic shock who have just undergone successful peripheral VA-ECMO placement and do not have contraindications to IABP are ideal candidates.

Not a fit: Patients with isolated right ventricular failure, non-cardiac indications for VA-ECMO, moderate-to-severe aortic regurgitation or aortic dissection, severe peripheral vascular disease, or those already supported with LVAD/Impella/IABP are unlikely to benefit from randomization into this trial.

Why it matters

Potential benefit: If successful, the approach could lower early mortality and improve organ perfusion and recovery in patients with cardiogenic shock on VA-ECMO.

How similar studies have performed: Observational and smaller cohort studies have suggested LV unloading can improve hemodynamics, but randomized evidence is limited and results to date are mixed, so this remains a relatively novel randomized test.

Eligibility criteria

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:

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

Where this trial is running

Beijing, Beijing Municipality

• Beijing Anzhen Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Xiaotong Hou, MD, PhD — Beijing Anzhen Hospital
• Study coordinator: Xiaotong Hou, MD, PhD

Conditions ECMO; IABP; LV unloading