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临床试验/CTRI/2024/11/077412
CTRI/2024/11/077412尚未招募4 期

The effect of N-Acetylcysteine on red blood cell transfusion burden in transfusion dependent Beta thalassemia children A open labelled experimental study

Multidisciplinary Research Unit1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年12月8日最近更新:

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

发起方
Multidisciplinary Research Unit
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Shajathi Begum N

Institute of child health,Egmore,Chennai

研究点 (1)

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