CTRI/2024/03/063692尚未招募不适用
Effect of Hydroxyurea on fetal hemoglobin(HbF) in sickle cell anemia and its impact on splenic function and biochemical parameters in a tertiary care hospital
Sura. Amarendar1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年3月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Anticipate a statistically significant increase in HbF levels in Sickle Cell Anemia patients following Hydroxyurea treatment.
研究概览
简要总结
This study intended to evaluate the effectiveness of Hydroxyurea on sickle cell patients by clinical and laboratory findings, splenic function and long-term compliance
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 3.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Painful crises (in the past 12 months, there were more than three occurrences) More than two blood transfusions in the last 12 months.
- •The term "painful crisis" refers to an acute painful occurrence that necessitates the use of oral or injectable analgesics and lasts for at least 4 hours when no other reason can be found to account for the symptom Patients under hydroxyurea therapy will be approached to enrol in this study to assess splenic hypofunction.
排除标准
- •children under the age of 3years and adults over 60years of age concomitant diseases such as neutropenia and thrombocytopenia may have increased the hydroxyureas toxicity Patients who are participating in a particular program or study that could have had an impact on their clinical or haematological state renal dysfunction is indicated by blood creatinine levels that are 1.5 time or more above normal.
结局指标
主要结局
Anticipate a statistically significant increase in HbF levels in Sickle Cell Anemia patients following Hydroxyurea treatment.
时间窗: 4weeks
次要结局
- Expect improvement in splenic function, as evidenced by imaging techniques, attributed to the reduction of sickle cell-related complications and improved overall hemoglobin profiles.
研究者
SURA AMARENDAR
Namo medical Education and Research Institute
研究点 (1)
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