Clinical trial NCT06872021: Early Intra-aortic Balloon Pump Use After Venoarterial Extracorporeal Membrane Oxygenation
Official title: Early Intra-aortic Balloon Pump Use After Venoarterial Extracorporeal Membrane Oxygenation: the EASE-ECMO Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ECMO
Keywords: ECMO
IABP
LV unloading
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 316 patients receiving peripheral VA-ECMO to the ECMO+IABP group (n=158) or the ECMO group (n=158). The primary end point was the 30-day rate of weaning from VA-ECMO.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Presence of moderate to severe aortic insufficiency
2. Severe peripheral vascular disease
3. Post-cardiotomy cardiogenic shock 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

Primary outcomes:
measure: Rate of weaning from VA-ECMO
timeFrame: 30 days
Secondary outcomes:
measure: Rate of advanced mechanical unloading
timeFrame: 30 days
measure: 30-day mortality
timeFrame: 30 days
measure: Rate of pulmonary congestion on chest X-ray
timeFrame: 30 days
measure: Lactate clearance rate at 12 and 24 hours
timeFrame: 30 days
measure: Relative decrease in vasoactive inotropic score(VIS) at 12 and 24 hours
timeFrame: 30 days
measure: Duration of VA-ECMO
timeFrame: 30 days
measure: Rate of ventricular arrhythmia
timeFrame: 30 days
measure: Rate of stroke
timeFrame: 30 days
measure: Rate of bleeding
timeFrame: 30 days
measure: Rate of limb ischemia
timeFrame: 30 days
measure: Rate of infection
timeFrame: 30 days
measure: Duration of mechanical ventilation
timeFrame: 30 days
measure: ICU length of stay
timeFrame: 30 days
measure: Hospital length of stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Xiaotong Hou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: