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A Study on the Effects of Left Ventricular Unloading in the Setting of VA ECMO Support

RecruitingNAAges 18 Years - anyAllErasmus Medical Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria for the registry backbone: * Having received ECMO support for severe circulatory and/or respiratory insufficiency Inclusion Criteria for the LV unloading trial domain (VA ECMO + IABP vs VA ECMO alone): * Cardiogenic shock * Having received VA ECMO support for severe circulatory (and respiratory insufficiency). * Age โ‰ฅ 18 years * Initiation of LV unloading (IABP or Impella) possible โ‰ค 8 hours after ECMO initiation Exclusion criteria for the registry backbone * 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). Exclusion criteria for the LV unloading trial domain (VA ECMO + IABP vs VA ECMO alone) * 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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What it tests

  • Intra-aortic balloon pump
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Where

14 sites
AZ Sint-Jan Brugge
Bruges, Belgium
ZOL Genk
Genk, Belgium
UZ Gent
Ghent, Belgium
Amphia hospital
Breda, Netherlands
Catharina hospital
Eindhoven, Netherlands
Amsterdam University Medical Center
Amsterdam, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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