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

Abstract

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 (DAH₉₀).

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], 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.

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.