Effect of Erythropoietin on Red Blood Cell Requirement in Children With Hemolytic Uremic Syndrome: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of RBC transfusions
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Erythropoietin
Erythropoietin plus standard of care (RBC transfusions if Hb ≤7 mg/dl and/or hemodynamic instability)
干预措施: erythropoietin (Drug)
结局指标
主要结局
Number of RBC transfusions
时间窗: 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
次要结局
- Erythropoietin levels(At the end of the 36 month study recruiting period)
研究者
Alejandro Balestracci
Principal Investigator
Hospital General de Niños Pedro de Elizalde