Erythropoietin in Hemolytic Uremic Syndrome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemolytic-Uremic Syndrome, Anemia

Intervention / Treatment
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* Drug: erythropoietin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erythropoietin<br>Erythropoietin plus standard of care (RBC transfusions if Hb ≤7 mg/dl and/or hemodynamic instability) | Drug: erythropoietin<br>* erythropoietin 50 International Units (IU) per kilogram three times weekly by subcutaneous route<br>* Other names: EPO;|
| No Intervention: No Intervention<br>Standard of care: RBC transfusions if Hb ≤7 mg/dl and/or hemodynamic instability | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of RBC transfusions | To determine if administration of erythropoietin decreases the number of RBC during the acute stage of hemolytic uremic syndrome | At the end of the 36 month study recruiting period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythropoietin levels | To determine if erythropoietin levels correlate with RBC transfusions requirement. | At the end of the 36 month study recruiting period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemolytic-Uremic Syndrome, erythropoietin, RBC transfusion