CTRI/2023/02/050071尚未招募不适用
Modulation in Serum Cation level of Pre and Post Plateletpheresis among donors
Institutional Seed money1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年2月27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
- 50
- 试验地点
- 1
- 主要终点
- Donors demographic detail and risk factors
研究概览
简要总结
- Informed written consent will be collected from donor who is registered for plateletpheresis.
- Blood samples will be collected in EDTA and plain vccutainer from sterile diversion pouch placed on apheresis circuit before starting and after the procedure for complete blood count and biochemical parameters.
- During the procedure, 250 mg of calcium tablet is given to the donor as a part of standard of care.
- Demographic and risk factors details will be collected from the donors and samples were analysed for the required parameter as per the proforma.
- Complete blood picture will be done using semi autoanalyser using EDTA sample.
- Plain samples are centrifuged, serum will be used for measurement of Calcium, Magnesium, by kit method and Sodium and Potassium levels using flame photometer.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy donors both male and female with age range 18-65 years Pre apheresis platelet count greater than equal to 150000/L Hemoglobin level greater than 12.5g/dL Donor body weight greater than equal to 60 kg.
排除标准
- •Donor with High blood pressure/ Diabetes mellitus/ Cardiac issues or an any drugs Donors who are reactive to the Transfusion Transmitted infections.
结局指标
主要结局
Donors demographic detail and risk factors
时间窗: 6 month
Complete blood count
时间窗: 6 month
Calcium:mg/dl
时间窗: 6 month
Magnesium:mg/dl
时间窗: 6 month
Sodium:mEq/Lt
时间窗: 6 month
Potassium:mEq/Lt
时间窗: 6 month
次要结局
- Variation in Complete blood picture(6 month)
研究者
研究点 (1)
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