Clinical relevance of immature platelet fraction in thrombocytopenia and its role in differentiating bone marrow suppression and destruction of platelets
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- • To determine immature platelet fraction in patients with thrombocytopenia using automated hematology analyzer (SYSMEX XN-1500)
研究概览
简要总结
Thrombocytopenia is a condition with low platelet counts resulting from decrease in bone marrow production of platelets or increase in platelet destruction. The reticulated platelets were discovered in 1969 and many research studies gave evidence of it being sensitive marker of thrombopoiesis. Earlier it was estimated by fluorescence flow cytometry but since 1990’s a new method is introduced to estimate reticulated platelets and is termed as automated method. Various platelet parameters obtained by automated hematology analyzer are Mean platelet volume, plateletcrit, platelet distribution width, platelet large cell ratio and immature platelet fraction. Immature platelet fraction is one of the component of automated method used to assess the thrombopoietic activity in bone marrow. Rinder et al. showed that an increased percentage of reticulated platelets indicated in thrombocytopenia correlated well with increased megakaryocytic proliferation in bone marrow whereas decrease in percentage of reticulated platelets indicated decrease in number of bone marrow megakaryocytes. Zeigler et al. reported that large platelets were seen in individuals with thrombocytopenia due to Immune thrombocytopenic purpura whereas platelet size was normal in patients with thrombocytopenia due to bone marrow aphasia, hypersplenism and thrombotic thrombocytopenic purpura with a normal platelet count. Briggs et al. in 2004 published a study done on SYSMEX XE stated, increase in immature platelet fraction was seen in individuals with immune thrombocytopenic purpura (mean 22.3%; range 9.2-33.1%) and thrombotic thrombocytopenic purpura (mean 17.2%; range 11.2-30.9%). The normal range was taken as 1.1-8.1%. They also noted that as the platelet count increases the immature platelet fraction percentage falls. Abe et al. showed that the immature platelet fraction was significantly higher in patients with immune thrombocytopenic purpura and significantly lower in patients during the nadir phase post chemotherapy and in normal range in incomplete immune thrombocytopenic purpura patients and those with aplastic anemia. Linden et al. showed that immature platelet fraction could be used as a predictor of platelet recovery within 2 days using cut-off of 5.3% in patients receiving autologous stem cell transplantation.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •All adults (18years and above) having thrombocytopenia with a definitive diagnosis.
排除标准
- •All pediatric patients 2) Samples with platelet clumps 3) Patients on drug therapy / chemotherapy.
结局指标
主要结局
• To determine immature platelet fraction in patients with thrombocytopenia using automated hematology analyzer (SYSMEX XN-1500)
时间窗: 11 months (1 march 2023 to 28 february 2024)
• To determine normal reference range of immature platelet fraction in healthy controls
时间窗: 11 months (1 march 2023 to 28 february 2024)
次要结局
- To determine whether immature platelet fraction can be used reliably to distinguish between hypo-productive thrombocytopenia and hyper-destructive thrombocytopenia(11 months (1 march 2023 to 28 february 2024))
