A Study on the Effects of Left Ventricular Unloading in the Setting of VA ECMO Support
Randomized Embedded Multifactorial Adaptive Platform in ExtraCorporeal Membrane Oxygenation (REMAP ECMO) - Left Ventricular Unloading Study
Erasmus Medical Center
430 participants
Jun 8, 2023
INTERVENTIONAL
Conditions
Summary
REMAP ECMO is a registry based platform in which multiple response adaptive randomized clinical trials (trial domains) will be embedded. These trial domains will, in a perpetual way, study the effects of a range of patient management strategies which aim to improve VA ECMO weaning success. A first trial domain will address the effects of left ventricular (LV) unloading through intra-aortic balloon pumping on weaning succes in VA ECMO supported patients.
Eligibility
Inclusion Criteria5
- Having received ECMO support for severe circulatory and/or respiratory insufficiency
- Cardiogenic shock
- Having received VA ECMO support for severe circulatory (and respiratory insufficiency).
- Age ≥ 18 years
- Initiation of LV unloading (IABP or Impella) possible ≤ 8 hours after ECMO initiation
Exclusion Criteria11
- Objection to participation in the registry by the patient and/or proxy
- VA ECMO usage confined to the period during surgery or another intervention (the VA ECMO was removed at the end of the intervention in the operation room).
- No (deferred) informed consent provided by the patient and/or proxy.
- Pregnancy
- ECMO usage confined to the period during surgery or another intervention (the ECMO was removed at the end of the intervention).
- Isolated right ventricular failure (e.g. due to pulmonary embolism).
- Left ventricular assist device (LVAD), Impella or IABP in situ.
- Ventricular septal defect or papillary muscle rupture as the cause of shock.
- Thoracic or abdominal aortic dissection.
- Moderate or severe aortic regurgitation
- Mechanical prosthesis in mitral valve position
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Interventions
An IABP is placed percutaneously into the thoracic aorta and supports the heart through synchronized inflation and deflation of a balloon.
Locations(14)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05913622