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

NCT ID: NCT06872021

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 358 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-12-01

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ECMO+IABP group

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

Group Type: EXPERIMENTAL

Early IABP use

Intervention Type: OTHER

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

ECMO group

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

Group Type: ACTIVE_COMPARATOR

Conventional approach

Intervention Type: OTHER

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

Interventions

Early IABP use

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

Intervention Type: OTHER

Conventional approach

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaotong Hou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaotong Hou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Xiaotong Hou, MD, PhD

Role: CONTACT

xt.hou@ccmu.edu.cn

010-64456631

Facility Contacts

Liangshan Wang, MD

Role: primary

wangliangshanbam@sina.com

Other Identifiers

KS2025197

Identifier Type: -

Identifier Source: org_study_id