RecruitingNot ApplicableNCT06872021

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

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

Sponsor

Beijing Anzhen Hospital

Enrollment

358 participants

Start Date

Mar 22, 2026

Study Type

INTERVENTIONAL

Conditions

ECMO

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria14

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