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临床试验/CTRI/2020/10/028311
CTRI/2020/10/028311已完成不适用

Analysis of immediate and delayed adverse events in voluntary platelet donorsassociated with plateletpheresis procedure.

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年10月14日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
1
主要终点
To study immediate & delayed adverse events in plateletpheresis donors.

研究概览

简要总结

Platelets are tiny blood cells that help our body to form clots to stop bleeding. Plateletpheresis or platelet donation is the procedure in which blood is drawn from a donor, platelets are separated and the remainder is returned to the donor.

The procedure is carried out on a machine, called cell separator. The procedure of plateletpheresis  is generally well tolerated and considered safe, involves minimal risk of adverse events. Adverse events of variable severity may occur during or after the plateletpheresis procedure. Adverse events can be divided into immediate & delayed and also local & systemic. Immediate reactions are the ones which are experienced by donor, when he /she is in hospital. Delayed reactions are those which are experienced by donor after leaving the hospital.  Immediate reactions like pain/ swelling at venepuncture site  etc.   are noted in apheresis register and are managed in  the hospital. But Delayed reactions generally go unnoticed.

In this study, the voluntary platelet donors willing to participate in the study are telephonically contacted between day 7- day 8 of their platelet donation and a set of questionnaire is asked to note down any delayed reactions he / she might have experienced.

Our Institute being an oncology center has around 4000 procedures of plateletpheresis  each year. Analysis of adverse events, immediate & delayed will help to understand susceptible donors, incidence of various adverse events. The study will also help in donor retention, improve donor safety, increase donation frequency & thereby maintaining platelet donor pool & supply.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • The donors who fulfil the eligibility criteria for platelet donation, as per SOP, will be included in study.

排除标准

  • The donors who do not fulfil eligibility criteria for platelet donation, as per SOP, will be excluded from the study.

结局指标

主要结局

To study immediate & delayed adverse events in plateletpheresis donors.

时间窗: The adverse events experienced by platelet donors will be analysed over a period of 4 months

次要结局

  • To analyze factors associated with these adverse events if any.(It will be analysed over a period of 4 months)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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