A Randomised Trial to Determine Whether the Interval Between Blood Donations in England Can be Safely and Acceptably Decreased
试验速览
- 阶段
- 不适用
- 入组人数
- 50,000
- 试验地点
- 50
- 主要终点
- Total blood collected after two years
研究概览
简要总结
It is hypothesised that the number of donations made by English blood donors will be greater with reduced vs. standard inter-donation intervals. The null hypothesis is that there will be no difference in donations between treatment groups; this may arise if reduced inter-donation intervals result in a greater number of donation deferrals (due to low haemoglobin) and/or an unacceptable burden to donors.
详细描述
50,000 blood donors will be recruited from permanent blood donation centres across England to compare different intervals between blood donations to try to find the optimum interval for which it is safe for different donors to give blood. The study will look at whether intervals should be tailored by age, gender, genetic profile, and other characteristics. Study findings should help to improve the well-being of future blood donors in England and enhance the country's blood supplies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or older and fulfilling all normal criteria for blood donation
- •Willing to be assigned to any of the study intervention groups
- •Registered at one of the permanent donation clinics at the time of enrolment
排除标准
- •As the aim of the study is to be almost "paper-less", it will involve remote web-based data collection. Hence, participants who do not have internet access and/or are not willing to provide an email address for study correspondence will be excluded.
研究组 & 干预措施
Male - 8 weeks
Male donors assigned to an 8 week donation interval frequency
干预措施: Reduced versus standard intervals between blood donations (Other)
Male - 12 weeks
Male donors assigned to 12 week donation interval frequency
Female - 12 weeks
Female donors assigned to 12 week donation interval frequency
干预措施: Reduced versus standard intervals between blood donations (Other)
Female - 14 weeks
Female donors assigned to 14 week donation interval frequency
干预措施: Reduced versus standard intervals between blood donations (Other)
Female - 16 weeks
Female donors assigned to 16 week donation interval frequency
Male - 10 weeks
Male donors assigned to 10 week donation interval frequency
干预措施: Reduced versus standard intervals between blood donations (Other)
结局指标
主要结局
Total blood collected after two years
时间窗: 24 months
Expressed in units (470ml) per person per year
次要结局
- Levels of physical activity(24 months)
- Cost effectiveness(24 months)
- Markers of iron status(24 months)
- Number of donation deferrals(24 months)
- Donor attitudes, beliefs and values(24 months)
- Cognitive ability(24 months)
- Donor quality of life(24 months)
研究者
Professor Danesh
Professor of Epidemiology and Medicine, Head of Department of Public Health and Primary Care
University of Cambridge