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

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

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.

Study Overview

• Status: Recruiting
• Conditions: ECMO
• Intervention / Treatment: Other: Early IABP use; Other: Conventional approach

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.

• Study Type: Interventional
• Enrollment (Estimated): 358
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaotong Hou, MD, PhD; Phone Number: 010-64456631; Email: xt.hou@ccmu.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Recruiting
      • Beijing Anzhen Hospital
      • Contact: Liangshan Wang, MD; Phone Number: 86-13811363372; Email: wangliangshanbam@sina.com
      • Principal Investigator: Xiaotong Hou Hou, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ECMO+IABP group; Patients receive IABP for left ventricular unloading within 6 hours after VA-ECMO initiation.	Other: Early IABP use; Patients receive IABP for left ventricular unloading within 6 hours after VA-ECMO initiation.
Active Comparator: ECMO group; Patients do not receive mechanical unloading within 6 hours after VA-ECMO initiation.	Other: Conventional approach; Patients do not receive mechanical unloading within 6 hours after VA-ECMO initiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
30-day mortality	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay		30 days
Duration of mechanical ventilation		30 days
ICU length of stay		30 days
Rate of advanced mechanical unloading		30 days
Rate of pulmonary congestion on chest X-ray		30 days
Lactate clearance rate at 12 and 24 hours		30 days
Relative decrease in vasoactive inotropic score(VIS) at 12 and 24 hours	Vasoactive inotropic score (VIS), in µg/kg/min, was calculated as follows: dopamine + dobutamine + 100 epinephrine + 100 norepinephrine + 15×milrinone. Higher VIS predict worse outome.	30 days
Duration of VA-ECMO		30 days
Rate of ventricular arrhythmia		30 days
Rate of stroke		30 days
Rate of bleeding	BARC type III or V	30 days
Rate of infection	With or without culture result	30 days
weaning from VA-ECMO		30 days
Left Ventricular Function of survivors		30 days
In-hospital Mortality		30 days
Day of Mechanical Circulatory Support Device Weaning		30 days
Reduction in Myocardial Injury Biomarkers (cTnI/cTnT)		30 days
Reduction in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP)		30 days
Rate of CRRT		30 days
Rate of limb ischemia	ECMO side/ IABP side	30 days

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Investigators: Principal Investigator: Xiaotong Hou, MD, PhD, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 12, 2025

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ECMO; IABP; LV unloading
• Other Study ID Numbers: KS2025197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No