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

ConditionECMO
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early IABP use

    Other intervention

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

  • Conventional approach

    Other intervention

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

Treatment groups

358 Participants
are divided into 2 treatment groups
Group A: ECMO+IABP groupExperimental treatment 1 intervention
Group B: ECMO groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

30-day mortality

Time frame
30 days

Secondary outcomes

1

weaning from VA-ECMO

Time frame
30 days
2

Rate of advanced mechanical unloading

Time frame
30 days
3

Left Ventricular Function of survivors

Time frame
30 days
4

In-hospital Mortality

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Anzhen Hospital

Lead sponsor

Source ClinicalTrials.gov
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