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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ≥ 18 years
* Initiation of LV unloading (IABP or Impella) possible ≤ 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is specifically looking at left ventricular unloading while someone is on VA ECMO for cardiogenic shock — is my situation serious enough that VA ECMO is even being considered, and would that make me a potential candidate worth discussing with you?
2Since this trial is listed as 'Phase NA,' meaning it's more of an observational or mechanistic study rather than a standard drug or device trial, can you explain what that means for my safety and what exactly would be different about my care if I participated?
3The study is measuring whether patients can be successfully weaned off ECMO — what does 'weaning success' look like in practice, and how would being in this study affect the decisions your team makes about when and how to take me off ECMO support?
4There's a physiological substudy measuring end diastolic volume, which relates to how much the heart is filling and stretching — would I need additional imaging or monitoring procedures as part of this, and how would that affect my time in the hospital or ICU?
5Given how critical cardiogenic shock is, what are the standard treatment approaches you'd use regardless of this trial, and is there any reason you'd recommend I focus on standard care first before considering participation in a study like this?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.