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临床试验/CTRI/2024/05/067294
CTRI/2024/05/067294招募中不适用

Assessment of efficacy of dexamethasone as compared to prednisolone as first line oral steroid for remission of thrombocytopenia in acute immune thrombocytopenic purpura in children, a single centered open label randomized control trial.

All India Institute of Medical Sciences, Patna1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年5月24日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
92
试验地点
1
主要终点
Improvement or resolution of thrombocytopenia

研究概览

简要总结

The study has been proposed to be done by the Department of Paediatric Medicine.Purpose of the study is to determine the efficacy of dexamethasone when compared to prednisolone as a first line steroid to be used in patients of acute ITP in children. Once the diagnosis of ITP has been established a baseline CBC will be done to look for platelet counts and other haematological parameters. Children will then be allotted a group by randomisation using an opaque sealed enveloped technique and will be divided in group A (will receive Dexamethasone 40 mg for a total duration of 4 days) and group B (will receive Prednisolone at 2 mg/kg/day for 14 days and then taper over next 2 weeks). Child will be monitored for bleeding manifestations. A repeat CBC will be done as per clinical indication and at 1 and 3 months following the initial presentation. Then the child will be evaluated for complete response, response and no response. Then using relevant statistical test, the outcome will be inferred.The interested subjects who are willing to participate in the research will be given the Participant Informed consent form (PICF) which they are abide to fill after reading. Further, the data will be captured in a Data capture sheet. The data will be collected, assembled and analysed using Statistical Product and Service Solutions (SPSS version 22) software package for Windows/Mac, Student Edition.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Patients of ITP visiting OPD/admitted in Paediatrics ward of AIIMS Patna who are between 1 to 18 years of age and have not received steroids in past 1 month and require treatment as per the protocol.

排除标准

  • Patients with inherited platelet disorders (Bernard-Soulier syndrome, Glanzmann thrombasthenia, etc.)
  • Patients with known rheumatological diseases already on steroids or steroid sparing drugs (SLE, APLA, etc.)
  • Patients with known malignancy receiving chemotherapy and/or radiotherapy.
  • Patients of aplastic anemia
  • Patients of chronic or persistent ITP
  • Patients taking antiplatelet drugs.
  • Patients who received steroid(s) or IVIG or platelet transfusion(s) prior to presenting to AIIMS Patna.

结局指标

主要结局

Improvement or resolution of thrombocytopenia

时间窗: At baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7, 1 month and 6 months

次要结局

  • a. To assess the likelihood of progression to persistent ITP in children treated with dexamethasone as compared to that with of prednisolone.(6 months)
  • b. Time spent under the danger zone of risk of bleeding i.e., platelet count less than 20,000/mm3 during treatment with either agent(6 months)
  • To assess the need for platelet transfusion in both categories(6 months)
  • To compare the steroid toxicity/adverse effects in both categories(6 months)

研究者

发起方
All India Institute of Medical Sciences, Patna
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Utkarsh Srivastava

All India Institute of Medical Sciences, Patna

研究点 (1)

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