The effect of N-Acetylcysteine on red blood cell transfusion burden in transfusion dependent Beta thalassemia children A open labelled experimental study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Reduction in burden of RBC transfusion
研究概览
简要总结
Two to twelve years old Beta thalassemia children on regular blood transfusion and iron chelation will be considered for the study.After applying the inclusion and exclusion criteria and obtaining informed written consent from the parents,children will be enrolled as study group.Baseline characteristics,mean pretransfusion Hb,LFT,Serum ferritin,transfusion volume over the last three months will be recorded.NAC will be administered at a dose of 10mg/kg/day.At their regular follow up(3 to 4weeks interval),per transfusion Hb and volume of transfusion will be noted.At the end of three months,mean per transfusion Hb,volume of transfusion over last three months and Serum ferritin will be noted.Statistical association will be analysed using paired t test.p value less than 0.05 will be considered significant .
Durin the study period,patients will be called over telephone everyday for the initial two weeks and weekly once thereafter to ensure compliance and also address their concerns if any.Empty tablet blisters will be checked at regular follow up.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •All transfusion dependent Beta thalassemia children on regular blood transfusion and iron chelation therapy Serum ferritin 2500-3000ng/ml.
排除标准
- •Renal/hepatic impairment Change in dose of iron chelater within three months before enrolment Alloimmunisation.
结局指标
主要结局
Reduction in burden of RBC transfusion
时间窗: 1. Total volume of blood transfused over the last three months will be assessed at baseline prior to starting N-Acetylcisteine. At the end of study period, the volume of blood transfused over the last 3 months will be assessed | 2. Pre-transfusion Hb will be checked at baseline, every 3 weeks and at the end of study period.
Increase in hemoglobin levels
时间窗: 1. Total volume of blood transfused over the last three months will be assessed at baseline prior to starting N-Acetylcisteine. At the end of study period, the volume of blood transfused over the last 3 months will be assessed | 2. Pre-transfusion Hb will be checked at baseline, every 3 weeks and at the end of study period.
次要结局
- Decrease in Serum ferritin(Serum ferritin will be checked at baseline, at the end of 3 months)
研究者
Dr Shajathi Begum N
Institute of child health,Egmore,Chennai
