Erythropoietin in Hemolytic Uremic Syndrome

Phase 4

Completed

• Conditions: Hemolytic-Uremic Syndrome; Anemia
• Interventions: Drug: erythropoietin

• Registration Number: NCT03776851
• Lead Sponsor: Hospital General de Niños Pedro de Elizalde

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.

Study Timeline

• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-17
• Study Start: 2019-01-01
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erythropoietin	erythropoietin	Erythropoietin plus standard of care (RBC transfusions if Hb ≤7 mg/dl and/or hemodynamic instability)

Primary Outcome Measures

Name	Time	Method
Number of RBC transfusions	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 Outcome Measures

Name	Time	Method
Erythropoietin levels	At the end of the 36 month study recruiting period	To determine if erythropoietin levels correlate with RBC transfusions requirement.

Trial Locations

Locations (1)

HGNPE; 🇦🇷 Caba, Argentina