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临床试验/NCT02010879
NCT02010879已完成不适用

The Impact of Platelet Count, Platelet Mass Index and Platelet Function Evaluated by Platelet Function Analyzer (PFA-100) on Spontaneous Ductal Closure in Preterm Infants

Ankara University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年12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
80
试验地点
1
主要终点
spontaneous ductal closure

研究概览

简要总结

Although thrombocytopenia has been reported as a risk factor for patent ductus arterioses, there is lack of data on the function of platelets in ductal closure. Information on functions of platelets in ductal closure may change the known model for ductus arterioses and may affect the treatment modalities.

详细描述

Patent ductus arterioses is a common problem which involves both pulmonary and cardiac outcomes in preterm infants. Although thrombocytopenia has been reported as a risk factor for patent ductus arterioses, there is lack of data on the function of platelets in ductal closure.

The investigators aim to investigate the relation between thrombocytopenia and platelet functions in pathogenesis of spontaneous ductal closure. The investigators hypothesize that Information on functions of platelets in ductal closure may change the known model for ductus arterioses and may affect the treatment modalities.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Days 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • gestational age lower than 30 weeks and birth weight lower than 1500 g
  • obtained informed consent

排除标准

  • any received medical treatment in first 2 days of life
  • death in first 2 days
  • patients who received any thrombocyte or fresh frozen plasma suspensions
  • any known genetic thrombocyte disorder in the family

结局指标

主要结局

spontaneous ductal closure

时间窗: 8 weeks

ductal closure confirmed by echocardiography on postnatal 2-3 days

次要结局

  • need for treatment(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omer Erdeve

Associate Professor

Ankara University

研究点 (1)

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