Early intra-aortic balloon pump (IABP) use after venoarterial ECMO for cardiogenic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, randomized trial will enroll 358 adults with cardiogenic shock who have had successful peripheral VA-ECMO implantation and randomly assign them to early IABP plus ECMO or to conventional ECMO care alone. The primary outcome is 30-day mortality, with secondary clinical outcomes tracked during follow-up. Key exclusions include moderate-to-severe aortic insufficiency or aortic dissection, severe peripheral vascular disease, isolated right ventricular failure, non-cardiac indications for ECMO, and prior use of other mechanical circulatory supports. The parallel-group design aims to generate controlled evidence on whether early left ventricular unloading with IABP improves outcomes compared with standard management.

Why it matters

Who can join: the full rules

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

Where it's running

• Beijing Anzhen Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Xiaotong Hou, MD, PhD — Beijing Anzhen Hospital
• Study coordinator: Xiaotong Hou, MD, PhD
• Email: xt.hou@ccmu.edu.cn
• Phone: 010-64456631

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.