跳至主要内容
临床试验/CTRI/2023/12/060625
CTRI/2023/12/060625尚未招募不适用

To Study the role of immature platelet fraction in children with severe thrombocytopenia

MANIPAL ACADEMY OF HIGHER EDUCATION1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年12月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
试验地点
1
主要终点
The role of immature platelet fraction in severe

研究概览

简要总结

The assessment of bone marrow thrombopoietic activity in patients with thrombocytopenia is necessary to achieve an accurate diagnosis and administer effective Treatment.Immature platelets can be useful marker of thrombopoietic activity.They represent the most recently produced platelets released into the circulation by regenerated bone marrow megakaryocytes.The number of circulating immature platelets reflects the rate of thrombopoiesis and bone marrow function and, as such, may be useful in the determination of thrombocytopenic etiology.A study done in UK in the year 2019 showed the IPF was significantly higher in cases of increased platelet consumption compared with controls. Another study in Republic of Korea between January 2016 to July 2018 showed IPF is higher in hyper destructive thrombocytopenia compared to control group. In this study the blood sample collected during admission for evaluation purpose will be used for estimation of immature platelet fraction in all the children included in the study. The sample will be processed at the earliest and processed by flowcytometry using optical fluorescence method. The data collected at the end of the study will be used to study the role of immature platelet fraction in different aetiologies of severe thrombocytopenia.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Month(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Cases: Children from 1month to 18years of age with severe thrombocytopenia having Platelet count less than 1,00,000 per microlitre.
  • Control: Controls: Children from 1month to 18years of age with platelet counts within normal limits 1,50,000/microlitre to 4,50,000/microlitre.

排除标准

  • Children diagnosed with haematological malignancies (leukaemia, lymphoma) and currently on anti-cancer drugs.
  • Children previously diagnosed of idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, aplastic anemia on disease specific treatment.
  • Children who had received platelet transfusion in the past 1 month.

结局指标

主要结局

The role of immature platelet fraction in severe

时间窗: 18 MONTHS

thrombocytopenia and its range in paediatrics population in different aetiologies will

时间窗: 18 MONTHS

be analysed at the end of the study after 18 months

时间窗: 18 MONTHS

次要结局

未报告次要终点

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Aishwarya N

Kasturba Medical college, Manipal, MAHE

研究点 (1)

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