Moore Carmel, Sambrook Jennifer, Walker Matthew, Tolkien Zoe, Kaptoge Stephen, Allen David, Mehenny Susan, Mant Jonathan, Di Angelantonio Emanuele, Thompson Simon G, Ouwehand Willem, Roberts David J, Danesh John
Department of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, Worts Causeway, Cambridge CB1 8RN, UK.
Trials. 2014 Sep 17;15:363. doi: 10.1186/1745-6215-15-363.
Ageing populations may demand more blood transfusions, but the blood supply could be limited by difficulties in attracting and retaining a decreasing pool of younger donors. One approach to increase blood supply is to collect blood more frequently from existing donors. If more donations could be safely collected in this manner at marginal cost, then it would be of considerable benefit to blood services. National Health Service (NHS) Blood and Transplant in England currently allows men to donate up to every 12 weeks and women to donate up to every 16 weeks. In contrast, some other European countries allow donations as frequently as every 8 weeks for men and every 10 weeks for women. The primary aim of the INTERVAL trial is to determine whether donation intervals can be safely and acceptably decreased to optimise blood supply whilst maintaining the health of donors.
METHODS/DESIGN: INTERVAL is a randomised trial of whole blood donors enrolled from all 25 static centres of NHS Blood and Transplant. Recruitment of about 50,000 male and female donors started in June 2012 and was completed in June 2014. Men have been randomly assigned to standard 12-week versus 10-week versus 8-week inter-donation intervals, while women have been assigned to standard 16-week versus 14-week versus 12-week inter-donation intervals. Sex-specific comparisons will be made by intention-to-treat analysis of outcomes assessed after two years of intervention. The primary outcome is the number of blood donations made. A key secondary outcome is donor quality of life, assessed using the Short Form Health Survey. Additional secondary endpoints include the number of 'deferrals' due to low haemoglobin (and other factors), iron status, cognitive function, physical activity, and donor attitudes. A comprehensive health economic analysis will be undertaken.
The INTERVAL trial should yield novel information about the effect of inter-donation intervals on blood supply, acceptability, and donors' physical and mental well-being. The study will generate scientific evidence to help formulate blood collection policies in England and elsewhere.
Current Controlled Trials ISRCTN24760606, 25 January 2012.
老龄化人口可能需要更多输血，但血液供应可能因吸引和留住数量日益减少的年轻献血者存在困难而受到限制。增加血液供应的一种方法是更频繁地从现有献血者那里采集血液。如果能够以边际成本安全地通过这种方式采集更多献血，那么这将对血液服务大有裨益。英国国家医疗服务体系（NHS）血液与移植部门目前允许男性每12周献血一次，女性每16周献血一次。相比之下，其他一些欧洲国家允许男性每8周献血一次，女性每10周献血一次。INTERVAL试验的主要目的是确定献血间隔能否安全且可接受地缩短，以优化血液供应，同时保持献血者的健康。
方法/设计：INTERVAL是一项针对从NHS血液与移植部门的所有25个固定中心招募的全血献血者的随机试验。2012年6月开始招募约50,000名男性和女性献血者，并于2014年6月完成。男性被随机分配到标准的12周、10周和8周的献血间隔，而女性被分配到标准的16周、14周和12周的献血间隔。将通过对干预两年后评估的结果进行意向性分析来进行性别特异性比较。主要结局是献血次数。一个关键的次要结局是使用简短健康调查问卷评估的献血者生活质量。其他次要终点包括因血红蛋白低（及其他因素）导致的“延期献血”次数、铁状态、认知功能、身体活动和献血者态度。将进行全面的健康经济分析。
INTERVAL试验应能提供关于献血间隔对血液供应、可接受性以及献血者身心健康影响的新信息。该研究将产生科学证据，以帮助制定英国及其他地区的采血政策。
当前受控试验ISRCTN24760606，2012年1月25日。
Zotero 插件