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. 2023 Dec 14;25(4):201-206.
doi: 10.1016/j.ccrj.2023.10.007. eCollection 2023 Dec.

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

Edward Litton  1   2 , Craig French  3 , Alan Herschtal  4 , Simon Stanworth  5 , Susan Pellicano  1 , Anne Marie Palermo  1 , Samantha Bates  3 , Sarah Van Der Laan  1 , Ege Eroglu  1 , David Griffith  6 , Akshay Shah  7
Affiliations

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

Edward Litton et al. Crit Care Resusc. .

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.

Keywords: Anaemia; Critical care; Intensive care unit.

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Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: EL is a Critical Care and Resuscitation Editor. David Griffith received fees for speaking from Fresenius Kabi (2021) and for BD advisory board participation (2020). In both bases, fees were paid directly to DGs group at the University of Edinburgh. The other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
∗41 patients with one exclusion, seven patients with two exclusions.
See this image and copyright information in PMC

References

    1. Vincent J., Baron J., Reinhart K., Gattanoni L., Thijs L., Webb A., et al. Anemia and blood transfusion in critically ill patients. JAMA, J Am Med Assoc. 2002;288(12):1499–1507. doi: 10.1001/jama.288.12.1499. - DOI - PubMed
    1. Corwin H.L., Gettinger A., Pearl R.G., Fink M.P., Levy M.M., Abraham E., et al. The CRIT Study: anemia and blood transfusion in the critically ill—current clinical practice in the United States. Crit Care Med. 2004;32(1):39–52. doi: 10.1097/01.ccm.0000104112.34142.79. - DOI - PubMed
    1. Thomas J., Jensen L., Nahirniak S., Gibney R.T. Anemia and blood transfusion practices in the critically ill: a prospective cohort review. Heart Lung : J Crit Care. 2010;39(3):217–225. doi: 10.1016/j.hrtlng.2009.07.002. - DOI - PubMed
    1. Walsh T.S., Lee R.J., Maciver C.R., Garrioch M., Mackirdy F., Binning A.R., et al. Anemia during and at discharge from intensive care: the impact of restrictive blood transfusion practice. Intensive Care Med. 2006;32(1):100–109. doi: 10.1007/s00134-005-2855-2. (journal article) - DOI - PubMed
    1. Docherty A.B., Turgeon A.F., Walsh T.S. Best practice in critical care: anaemia in acute and critical illness. Transfus Med. 2018;28(2):181–189. doi: 10.1111/tme.12505. - DOI - PubMed

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