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Recruiting NCT06872021

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

No phase Interventional ECMO

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early IABP use, Conventional approach.
Who it may be relevant to
Registry conditions: ECMO. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Early IABP use
    Patients receive IABP for left ventricular unloading within 6 hours after VA-ECMO initiation.
  • Other Conventional approach
    Patients do not receive mechanical unloading within 6 hours after VA-ECMO initiation.

Primary outcome measures

  • 30-day mortality [Time frame: 30 days]
Secondary outcome measures (12)
  • weaning from VA-ECMO [Time frame: 30 days]
  • Rate of advanced mechanical unloading [Time frame: 30 days]
  • Left Ventricular Function of survivors [Time frame: 30 days]
  • In-hospital Mortality [Time frame: 30 days]
  • Day of Mechanical Circulatory Support Device Weaning [Time frame: 30 days]
  • Rate of pulmonary congestion on chest X-ray [Time frame: 30 days]
  • Duration of VA-ECMO [Time frame: 30 days]
  • Lactate clearance rate at 12 and 24 hours [Time frame: 30 days]
  • Relative decrease in vasoactive inotropic score(VIS) at 12 and 24 hours [Time frame: 30 days]
  • Reduction in Myocardial Injury Biomarkers (cTnI/cTnT) [Time frame: 30 days]
  • Reduction in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) [Time frame: 30 days]
  • Rate of CRRT [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

  • Age of ≥18
  • 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)
  • Successful implantation of VA-ECMO
  • Informed consent

Exclusion criteria

  • SCAI shock stage A or B
  • Presence of moderate to severe aortic insufficiency or aortic dissection
  • Severe peripheral vascular disease
  • Post-cardiotomy cardiogenic shock(non-CABG procedure) or bridging to cardiac procedure(heart transplantation or LVAD).
  • VA-ECMO for definite non-cardiac causes
  • Isolated right ventricular failure
  • V-A ECMO usage confined to the period during surgery or other interventions
  • Ischemic mechanical complications(eg Ventricular septal defect, papillary muscle rupture)
  • Extracorporeal cardiopulmonary resuscitation
  • LVAD, Impella or IABP in situ.
  • Severe bleeding
  • Terminal malignancy
  • Irreversible neurologic injury
  • Pregnancy or lactation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Anzhen Hospital — Beijing

Identifiers

NCT: NCT06872021 · KS2025197

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗