Iron and Erythropoietin to Heal and Recover after Intensive Care (ITHRIVE):A pilot RCT

AbstractObjectiveTo determine the feasibility of a pivotal randomised clinical trial of intravenous (IV) iron and erythropoietin in adult survivors of critical illness with anaemia requiring treatment in the intensive care unit.DesignAn investigator-initiated, parallel group, placebo-controlled, randomised, feasibility trial.SettingA tertiary intensive care unit (ICU) in Perth, Western Australia. ParticipantsAdults with anaemia (haemoglobin <100g/L), requiring ICU-level care for more than 48 hours and likely to be ready for ICU discharge within 24 hours.InterventionsA single dose of IV ferric carboxymaltose and Epoetin alfa (active group), or an equal volume of 0.9% saline (placebo group).Main outcome measuresStudy feasibility was considered met if the pilot achieved a recruitment rate of ≥2 participants per site per month, ≥ 90% of participants received their allocated study treatment, and≥ 90% of participants were followed up for the proposed pivotal trial primary outcome - days alive and at home to Day 90 (DAH90).ResultsThe 40-participant planned sample size included twenty in each group and were enrolled between 1/9/2021 and 2/3/2022. Participants spent a median of 3.4 days (interquartile range 2.8-5.1) in ICU prior to enrolment and had a mean baseline haemoglobin of 83.7g/L (standard deviation 6.7). The recruitment rate was 6.7 participants per month [95% confidence interval (CI) 4.8-9.0], DAH90 follow up was 100% (95% CI 91.2%-100%), and 39 (97.5%, 95% CI 86.8%-99.9%) participants received the allocated study intervention. No serious adverse events were reported. ConclusionThe ITHRIVE pilot demonstrated feasibility based on predefined participant recruitment, study drug administration and follow up thresholds