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Erythropoietin in Hemolytic Uremic Syndrome

Effect of Erythropoietin on Red Blood Cell Requirement in Children With Hemolytic Uremic Syndrome: a Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03776851
Enrollment
24
Registered
2018-12-17
Start date
2019-01-01
Completion date
2020-12-30
Last updated
2021-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Hemolytic-Uremic Syndrome

Keywords

Hemolytic-Uremic Syndrome, erythropoietin, RBC transfusion

Brief summary

This study will evaluate the impact of early administration of erythropoietin in the number of red blood cell transfusions in children with Shiga toxin-producing Escherichia coli hemolytic uremic syndrome (STEC-HUS).

Detailed description

Introduction: Anemia in STEC-HUS is treated with red blood cell (RBC) transfusions. It can causes hypervolemia, hyperkalemia, exacerbate the thrombotic state of the disease, transmit infectious agents and trigger antigenic sensitization. Anemia is mainly due to hemolysis, but deficit of erythropoietin synthesis (EPO) may aggravate it. Although recombinant human EPO is frequently used in children with STEC-HUS there is no adequate evidence of its benefit. If it is confirmed that EPO reduce the number of RBC transfusions, its administration could diminish the aforementioned risks and also reduce costs. Objective: To determine if EPO administration decreases the number of RBC transfusions and; secondarily, to assess if its levels influence on transfusion requirement. Methodology: Randomized, open controlled clinical trial. We will include 28 patients (14 per arm) \<18 years with STEC-HUS admitted to our hospital. They will be grouped after randomization:(1) One to standard of care (RBC transfusions with hemoglobin ≤7 mg / dl and/or hemodynamic instability) and (2) the other to standard of care plus EPO (50 u / kg subcutaneous three times weekly) and RBC transfusions with hemoglobin ≤7 mg / dl). Serum EPO will be measured by ELISA and together with the clinical and laboratory variables, association with RBC transfusions number will be sought. Written informed consent and assent when appropriate, will be requested prior to enter into the study.

Interventions

DRUGerythropoietin

erythropoietin 50 International Units (IU) per kilogram three times weekly by subcutaneous route

Sponsors

Hospital General de Niños Pedro de Elizalde
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

Inclusion criteria

* Post diarrheal HUS: Prodrome of enteritis followed by microangiopathic hemolytic anemia, thrombocytopenia and signs of renal damage (increased plasma creatinine, proteinuria, and / or hematuria). Proven STEC infection wiil not be required to enter into the study.

Exclusion criteria

* Atypical HUS * HUS associated with systemic diseases (pneumococcal infection, HIV, Systemic lupus erythematosus) or drugs * Anemia or known kidney disease * Previously transfused or treated with erythropoietin * Contraindications to erythropoietin

Design outcomes

Primary

MeasureTime frameDescription
Number of RBC transfusionsAt the end of the 36 month study recruiting periodTo determine if administration of erythropoietin decreases the number of RBC during the acute stage of hemolytic uremic syndrome

Secondary

MeasureTime frameDescription
Erythropoietin levelsAt the end of the 36 month study recruiting periodTo determine if erythropoietin levels correlate with RBC transfusions requirement.

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026