PRECISE
PRecision Ecmo in CardIogenic Shock Evaluation:
A Prospective, Multicentre Observational Study
Aim: Our primary aim is to create a predictive model, incorporating baseline biomarkers, that predicts disability free survival at day 180 in critically ill patients supported by venoarterial (VA) ECMO.
Our secondary aims are as follows: to investigate whether biomarkers taken longitudinally during VA ECMO describe different phenotypes of cardiogenic shock and to assess whether these phenotypes describe disability free survival at day 180.
Rationale: VA ECMO is a form of life support for patients with severe cardiogenic shock and cardiac arrest. Although it can be lifesaving, currently many patients still die or have long term disability, such as weakness, shortness of breath and cognitive impairments, and it remains extremely expensive. It is important that new ways of identifying which patients will gain the most benefit from ECMO are found, while also avoiding costly futile use when it there is no benefit.
The PRECISE Study is an Australian-led, nation-wide observational study that will investigate whether biomarkers can better guide decisions around who and how ECMO is delivered. The study will involve the collection of a small amount of blood (which would normally be discarded) at up to 4 different time points, including just prior to ECMO initiation, and also at days 1, 3, and 7 of ECMO support. These results will then be linked to the national ECMO registry which includes the important patient centred outcomes, such as disability at 6 months. This study will lead to the better support of a highly vulnerable population, and improve the efficiency of one of the most complex and costly interventions available.
Study Progress: Patient recruitment began in August 2023. A target of 236 adult patients commencing on VA ECMO will be enrolled at ECMO sites across Australia.
Trial Registration: ClinicalTrials.gov ID: NCT05748860
Funding: The PRECISE Study is funded by the NHMRC of Australia’s Medical Research Future Fund (MRFF) Cardiovascular Health Mission (MRF2017089).