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Randomized Controlled Trial
. 2022 Oct;37(10):2383-2392.
doi: 10.1007/s00467-022-05474-9. Epub 2022 Feb 15.

Erythropoietin in children with hemolytic uremic syndrome: a pilot randomized controlled trial

Alejandro Balestracci  1 , Marina Andrea Capone  2 , Luciana Meni Battaglia  2 , Ismael Toledo  2 , Sandra Mariel Martin  2 , Laura Beaudoin  2 , Jeanette Balbaryski  3 , Lorena Gómez  4
Affiliations
Randomized Controlled Trial

Erythropoietin in children with hemolytic uremic syndrome: a pilot randomized controlled trial

Alejandro Balestracci et al. Pediatr Nephrol. 2022 Oct.

Abstract

Background: The efficacy of recombinant human erythropoietin (rHuEPO) in sparing red blood cell (RBC) transfusions in children with hemolytic uremic syndrome related to Shiga toxin-producing Escherichia coli (STEC-HUS) is uncertain.

Methods: We conducted a pilot randomized controlled open trial between December 2018 and January 2021. Children were randomized to the intervention (subcutaneous rHuEPO 50 U/kg three times weekly until discharge + RBC transfusion if hemoglobin ≤ 7 g/dL and/or hemodynamic instability) or to the control arm (RBC transfusion if hemoglobin ≤ 7 g/dL and/or hemodynamic instability). Primary outcome was the number of RBC transfusions received during hospitalization. Secondary outcomes were to explore whether baseline EPO levels were adequate to the degree of anemia, to correlate selected acute phase parameters with the number of RBC transfusions, and to assess possible adverse events.

Results: Twelve patients per arm were included; they were comparable at recruitment and throughout the disease course. Median number of RBC transfusions was similar between groups (1.5, p = 0.76). Most patients had baseline EPO levels adequate to the degree of anemia, which did not correlate with the number of transfusions (r = 0.19, p = 0.44). Conversely, baseline (r = 0.73, p = 0.032) and maximum lactic dehydrogenase levels (r = 0.78, p = 0.003), creatinine peak (r = 0.71, p = 0.03) and dialysis duration (r = 0.7, p = 0.04) correlated significantly with RBC requirements. No side effects were recorded.

Conclusion: In children with STEC-HUS, the administration of rHuEPO did not reduce the number of RBC transfusions. Larger studies addressing higher doses and similar severity of kidney failure at rHuEPO initiation (e.g. at start of dialysis) are warranted.

Trial registration: ClinicalTrials.gov identifier: NCT03776851. A higher resolution version of the Graphical abstract is available as Supplementary information.

Keywords: Anemia; Children; Erythropoietin; Hemoglobin; Hemolytic uremic syndrome; Red blood cell transfusion.

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References

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