Acute cardiac care & resuscitation
A randomized embedded multifactorial adaptive platform for extra corporeal membrane oxygenation (Randomized Embedded Multifactorial Adaptive Platform (REMAP) Extracorporeal Membrane Oxygenation (ECMO)) – design and rationale of the left ventricular unloading trial domain
- early stopping for efficacy or futility
Study context
- Population
- Adult cardiogenic shock patients on veno-arterial (V-A) ECMO admitted to the Intensive Care Unit (ICU)
- Planned comparison
- Intra-aortic balloon pumping (IABP) as adjunct to V-A ECMO vs V-A ECMO alone
- Primary endpoint
- Successful weaning from ECMO: composite of survival without need for mechanical circulatory support, heart transplantation or left ventricular assist device (LVAD)
- Follow-up
- 30 days after ECMO initiation
Methodological detailsrandomised embedded multifactorial adaptive platform, registry-based platform, response adaptive randomization, Bayesian statistical framework, Secondary outcomes: need for interventional escalation of left ventricular (LV) unloading strategy, mechanistic endpoints, survival to 1 year, quality of life, Approved by the Medical Ethical Committee of the Erasmus Medical Center
- Randomised embedded multifactorial adaptive platform
- Registry-based platform
- Response adaptive randomization
- Bayesian statistical framework
- Secondary outcomes: need for interventional escalation of LV unloading strategy, mechanistic endpoints, survival to 1 year, quality of life
- Approved by the Medical Ethical Committee of the Erasmus Medical Center
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
A randomized embedded multifactorial adaptive platform for extra corporeal membrane oxygenation (REMAP ECMO) – design and rationale of the left ventricular unloading trial domain. Am Heart J. Published 22 October 2024. doi:10.
Summarised from the published abstract; every number is checked against it