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临床试验/NCT00549484
NCT00549484已完成不适用

Thrombopoietin Levels Following Platelet Transfusion in Neonates With Thrombocytopenia

Christiana Care Health Services1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2003年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Reduction in TPO levels following platelet transfusion

研究概览

简要总结

Infants who have low platelets and who require a platelet transfusion are included in this study. Platelet transfusions are routinely given to infants when their platelet count falls below a certain level. The study will look at the amount of platelets transfused. The purpose of the study is to evaluate the effect of platelet transfusions on the level of a protein (thrombopoietin) which is known to help control platelet production.

详细描述

Thrombocytopenia, defined as a platelet count < 150,000/mm3, is a very common hematologic problem in the neonatal period. Multiple etiologies are known to be associated with thrombocytopenia in neonates. Thrombopoietin (TPO) is known to be the central regulator of megakaryocyte and platelet production in adults and infants. However, the role of TPO in neonatal platelet regulation is not well understood. TPO levels have been shown to be higher in neonates with thrombocytopenia, with a decrease in TPO after resolution of the thrombocytopenia. The response of TPO levels in neonates after platelet transfusion has never been studied. In addition, the optimal volume of platelet transfusions has never been studied in neonates. This study will evaluate the response to 2 different volumes of platelet transfusion.

We hypothesize that a decrease in plasma TPO levels will be seen following a platelet transfusion in a population of neonates with thrombocytopenia. We also hypothesize that a platelet transfusion of 15 mL/kg will result in a greater rise in platelet count than a transfusion pf 10 mL/kg of platelets.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants with thrombocytopenia
  • Decision made by medical team to transfuse with platelets

排除标准

  • Infants with major congenital malformations

结局指标

主要结局

Reduction in TPO levels following platelet transfusion

时间窗: Within 36 hours of transfusion

次要结局

  • Platelet rise following platelet transfusion in 10 mL/kg versus 15 mL/kg.(Within 36 hours after platelet transfusion)

研究者

申办方类型
Other

研究点 (1)

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