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

Cardiogenic Shock Clinical Trial

Official title:
Randomized Embedded Multifactorial Adaptive Platform in ExtraCorporeal Membrane Oxygenation (REMAP ECMO) - Left Ventricular Unloading Study

Clinical Trial 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.

Clinical Trial Description

ExtraCorporeal Membrane Oxygenation (ECMO) is increasingly used but remains associated with high weaning failure- and mortality- rates. This seems in part attributable to a knowledge gap on how to properly manage ECMO and its related therapies as current knowledge and treatment protocols are based on observational studies and expert opinions. The "Randomized Embedded Multifactorial Adaptive Platform in ECMO" (REMAP ECMO) study was developed to study, in an efficient and randomized way, different ECMO related patient management issues and will consist of two parts: 1. A patient registry that will serve for quality monitoring and observational studies of ECMO patients being treated in participating centers. 2. Embedded within the registry, multiple response adaptive randomized clinical trials (trial domains) which aim to evaluate the effectiveness of a range of therapeutic interventions on ECMO weaning success. These interventions all have in common that they are all already used in ECMO care but their use depends on center and/or doctors preferences as no high quality (randomized) evidence guiding their indication, timing and management exists. A first trial domain to be initiated within the REMAP ECMO platform will address the effects of different left ventricular (LV) unloading techniques, through application of an intra-aortic balloon pump (IABP), on weaning success in the setting of venoarterial (VA) ECMO. The rationale of this trial domain is based on the increase in LV loading conditions, as induced by VA ECMO, which could lead to pulmonary edema, intracardiac thrombosis and even death. These serious sequelae could possibly be prevented by adding IABP as adjunct to VA ECMO therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05913622
Study type Interventional
Source Erasmus Medical Center
Contact Myrthe van Steenwijk
Phone +31627535136
Email m.p.j.vansteenwijk@erasmusmc.nl
Status Recruiting
Phase N/A
Start date June 8, 2023
Completion date June 1, 2028
View Details
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