A study to assess the transfusion efficacy of leukoreduced packed red blood cells prepared by two different methods in thalassemia major patients
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
- To detect a clinically significant difference of 0.3 g/dL rise in the hemoglobin increment between the two groups pf patients transfused with leukoreduced packed red blood cells prepared by the two different methods.
研究概览
简要总结
This study will be a prospective, randomized, controlled trial conducted by the Department of Transfusion Medicine, Nehru Hospital, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh in collaboration with the Department of Pediatrics of our Institute which caters to the thalassemia day care patients. Sample size for the study is based on a minimum clinically important difference of 0.3g/dL in Hb increment and a standard deviation of 0.3 for improvement in Hb. After enrolment in the study, the patients will be randomized into two groups. Groups will be formed by listing the patients in the order of requisitions received and then randomization will be done using a block randomization method. Group I will receive SLPRBC prepared by the standard method in our institute of removal of buffy coat and plasma followed by leukoreduction. Group II will receive NLPRBC prepared by a new method involving leukoreduction of whole blood followed by separation into plasma and packed red blood cells. Both groups will receive their respective LPRBC units for a total period of three months. The patients will be followed up for a period of three months, at the end of which the outcomes will be observed in the form of the Hb increment after each transfusion episode, average transfusion interval, total number of LPRBC units transfused during the period, and the frequency of transfusion reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Transfusion-dependent thalassemia major patients
- •Receiving transfusions exclusively at the PGIMER, Chandigarh.
排除标准
- •Minors (age<18 yrs)
- •Red cell autoantibodies in the patient
- •Massive splenomegaly
- •Any bleeding episode in the last 24 hours
- •Transfusion of any other blood product during the same episode
- •Pregnancy
- •Active ongoing fever or documented infection
- •Increased annual blood transfusion requirement (>200-220 mL/kg/year).
结局指标
主要结局
To detect a clinically significant difference of 0.3 g/dL rise in the hemoglobin increment between the two groups pf patients transfused with leukoreduced packed red blood cells prepared by the two different methods.
时间窗: 3 months
次要结局
- Effect on transfusion interval, number of units consumed(3 months)