Prospective Crossover Study on Beta(ß)-Thalassaemia Transfusion-dependent to Evaluate the Impact on Transfusion Regimen of Two Pre-storage Leukoreduced PRBCs(In-line Filtration + B-C Separation; Whole Blood Filtration + B-C Conservation)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Transfusion Power Index
研究概览
简要总结
This study compares the effects of Packed Red Blood Cells (PRBCs) prepared in two different ways on the transfusion indices in beta(ß)-Thalassemia transfusion-dependent patients. The two blood components types derive from the whole blood. In one case, the whole blood is leukoreduced with subsequent plasma removal. In the other case, plasma, buffy coat, and red blood cells (RBCs) are first separated and subsequently, the RBCs leukoreduced. Each type of blood components will be subsequently given to one-half of the patients for a 6-month period and to the other half for other 6-month at the randomization phase, for a total of 12 months of crossed-treatment per patient.
详细描述
At Day Hospital Talassemia ed Emoglobinopatie of Ferrara, two different PRBCs are available. The two types of blood components are obtained from whole blood, pre-storage leukoreduced and suspended in saline-adenine-glucose-mannitol (SAGM). One method of preparation consists of the whole blood leukoreduction with subsequent plasma removal. The other method first separates plasma, buffy coat, and RBCs, and then the RBCs are leukoreduced. The two methods mainly differ in the final haemoglobin (Hb) content: the Hb level is lower (-13%, approximately) in the second method that also shows the advantage to produce platelets from the buffy coat. A PRBCs unit is not as strictly defined as a therapeutic medication dose (pill or vial): individual PRBCs units may substantially differ in their Hb content, much more than the average difference between the two types of preparations. The aim of this study is to document the extent of the average difference between the two types of preparations, and its impacts on the transfusion indices of ß-Thalassaemia transfusion-dependent patients. All patients will receive each blood component for a period of 6 months (crossover design), for a total of 12 months of transfusion treatment per patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The patients will not be informed on the blood components sequence that they will receive. However, the units exterior appearance of the two types of preparations is different. For this reason, patients and care providers will most probably notice it.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with beta(ß)-Thalassaemia transfusion-dependent (ß-Thalassemia Major or ß-Thalassemia Intermedia transfusion-dependent, regularly transfused since at least 5 years
排除标准
- •Patient not exclusively transfused at Day Hospital Thalassaemia and Haemoglobinopathies of Ferrara
- •Patient with haemolytic auto-antibodies
- •Patient transfused with washed Packet RBCs units
- •Severe splenomegaly (>18 cm on echography)
- •Elevated blood consumption (>200 mL/kg of pure RBCs in the last year)
- •Patient receiving haemoglobin inducers in the last 6 months
- •Any significant clinical pulmonary, cardiovascular, endocrine, hepatic, gastrointestinal, renal, infectious, immunological including significant allo- or auto-immunisation disease, considered not adequately controlled prior to the study
- •Patient treated with erythrocyte exchange
- •Pregnant females
结局指标
主要结局
Transfusion Power Index
时间窗: For each of the two blood components studied, at the end of 6-month period of study
(Average pre-transfusion Hb concentration)/(Unit Index) \[for the definition of Unit Index, see the secondary outcomes\]
次要结局
- Average Transfusion Interval(For each of the two blood components studied, at the end of 6-month period of study)
- Average pre-transfusion Hb concentration(For each of the two blood components studied, at the end of 6-month period of study)
- Transfusion Reaction Rate(Study periods (2 periods of 6 months each))
- Number of Transfusion Reactions(Study periods (2 periods of 6 months each))
- Unit Index(For each of the two blood components studied, at the end of 6-month period of study)
研究者
Maria Rita Gamberini
Head, Day Hospital Thalassaemia and Haemoglobinopathies (DHTE) - Azienda Ospedaliero-Universitaria S.Anna of Ferrara
Università degli Studi di Ferrara