NCT06872021

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 358 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• ECMO

Interventions

Type	Name	Description
OTHER	Early IABP use	Patients receive IABP for left ventricular unloading within 6 hours after VA-ECMO initiation.
OTHER	Conventional approach	Patients do not receive mechanical unloading within 6 hours after VA-ECMO initiation.

Timeline

• Start date: 2026-03-22
• Primary completion: 2028-09-01
• Completion: 2028-12-01
• First posted: 2025-03-12
• Last updated: 2026-03-24

Locations

1 site across 1 country: China