Iron and erythropoietin to heal and recover after intensive care (ITHRIVE): A pilot randomised clinical trial

Objective: To 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.Design: An investigator-initiated, parallel group, placebo-controlled, randomised feasibility trial.Setting: A tertiary intensive care unit (ICU) in Perth, Western Australia.Participants: Adults with anaemia (haemoglobin <100 g/L), requiring ICU-level care for more than 48 h, and likely to be ready for ICU discharge within 24 h.Interventions: A single dose of IV ferric carboxymaltose and Epoetin alfa (active group) or an equal volume of 0.9% saline (placebo group).Main outcome measures: Study 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 (DAH(90)).Results: The 40-participant planned sample size included twenty in each group and was enrolled between 1/9/2021 and 2/3/2022. Participants spent a median of 3.4 days (interquartile range 2.8-5.1) in the ICU prior to enrolment and had a mean baseline haemoglobin of 83.7 g/L (standard deviation 6.7). The recruitment rate was 6.7 participants per month [95% confidence interval (CI) 4.8-9.0], DAH(90) 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.Conclusion: The iron and erythropoietin to heal and recover after intensive care (ITHRIVE) pilot demonstrated feasibility based on predefined participant recruitment, study drug administration, and follow-up thresholds.(c) 2023 The Authors. Published by Elsevier B.V. on behalf of College of Intensive Care Medicine ofAustralia and New Zealand. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).