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NCT Number: NCT03776851

Erythropoietin in Hemolytic Uremic Syndrome

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).

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Key information

Conditions

Hemolytic-Uremic Syndrome Anemia Anemia, Hemolytic Blood Platelet Disorders Cytopenia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Thrombocytopenia Thrombotic Microangiopathies Uremia Urogenital Diseases Urologic Diseases

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

HGNPE

CABA, 1417, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erythropoietin

Drug

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

Other names: EPO

Primary outcomes

  1. Number of RBC transfusions

    Time frame: At the end of the 36 month study recruiting period

    To determine if administration of erythropoietin decreases the number of RBC during the acute stage of hemolytic uremic syndrome

Secondary outcomes

  1. Erythropoietin levels

    Time frame: At the end of the 36 month study recruiting period

    To determine if erythropoietin levels correlate with RBC transfusions requirement.

Sponsors and collaborators

Lead sponsor

Hospital General de Niños Pedro de Elizalde

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 17, 2018
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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