Early Intra-aortic Balloon Pump Use After Venoarterial Extracorporeal Membrane Oxygenation (EASE-ECMO)

Capital Medical University

Status: Not yet enrolling

Conditions: ECMO

Treatments: Other: Early IABP use; Other: Conventional approach

Study type: Interventional

Funder types: Other

Identifiers

NCT06872021

KS2025197

Details and patient eligibility

About

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.

Full 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.

Enrollment: 358 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. Presence of moderate to severe aortic insufficiency or aortic dissection
2. Severe peripheral vascular disease
3. Post-cardiotomy cardiogenic shock(non-CABG procedure) or bridging to cardiac procedure.
4. VA-ECMO for definite non-cardiac causes
5. Extracorporeal cardiopulmonary resuscitation
6. Implantation of IABP or IMPELLA before VA-ECMO
7. Severe bleeding
8. Terminal malignancy
9. Irreversible neurologic injury
10. Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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358 participants in 2 patient groups

ECMO+IABP group

Experimental group

Description:

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

Treatment:

Other: Early IABP use

ECMO group

Active Comparator group

Description:

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

Treatment:

Other: Conventional approach