Hypoxia and Outcome Prediction in Early-Stage Coma (Project HOPE): an observational prospective cohort study

Alex Lopez-Rolon, Andreas Bender, on behalf of the Project HOPE Investigator Group

The number of resuscitated cardiac arrest patients suffering from anoxic-ischemic encephalopathy is considerable. However, outcome prediction parameters such as somatosensory evoked potentials need revision because they are based on data predating the implementation of mild therapeutical hypothermia and because data from our own laboratory suggest that they may fail to predict prognosis accurately. The present research project "Hypoxia and Outcome Prediction in Early-Stage Coma" is an ongoing observational prospective cohort study that aims to improve outcome prediction in anoxic coma by limiting the effects of falsely pessimistic predictions at the intensive care unit. Our outcome analysis is based on functional and behavioural definitions. This implies the analysis of the positive predictive value of prognostic markers yielding either positive or negative results. We also analyse the effect of covariates adjusted for age and sex such as sociodemographic variables, prognostic variables and treatment factors on functional and behavioural outcomes, with mixed effects regression models (i.e. fixed and random effects). We expect to enrol 172 patients based on the result of previous research. The null hypothesis is that there is a probability of <10 % that a positive outcome will be observed despite the presence of any of the predictors of a poor/negative outcome. We test the null hypothesis against a one-sided alternative using a Simon's two-stage design to determine whether is warranted to recruit the full number of patients suggested by a power analysis. The second stage has a design with a Type I error rate of 0.05 and 80 % power if the true response rate is 25 %. We aim to make a significant contribution to the revision and improvement of current outcome prediction methods in anoxic-ischemic encephalopathy patients. As a result, neurocritical care specialists worldwide will have considerably more accurate methods for prognosticating the outcome of anoxic-ischemic encephalopathy following cardiac arrest. This will facilitate the provision of treatment tailored to individual patients and the attainment of an optimal quality of life. It will also inform the decision to withdraw treatment with a level of accuracy never seen before in the field. ClinicalTrials.gov NCT02231060 (registered 29 August 2014).