The INTERVAL trial to determine whether intervals between blood donations can be safely and acceptably decreased to optimise blood supply: study protocol for a randomised controlled trial.
The INTERVAL trial to determine whether intervals between blood donations can be safely and acceptably decreased to optimise blood supply: study protocol for a randomised controlled trial.
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DOI：
10.1186/1745-6215-15-363
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发表时间：
2014-09-17
期刊：
影响因子：
2.5
通讯作者：
Danesh J
中科院分区：
文献类型：
--
作者：
Moore C;Sambrook J;Walker M;Tolkien Z;Kaptoge S;Allen D;Mehenny S;Mant J;Di Angelantonio E;Thompson SG;Ouwehand W;Roberts DJ;Danesh J
人口老龄化可能需要更多的输血，但血液供应可能会受到吸引和留住年轻献血者的困难的限制。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。如果能以这种方式以边际成本安全地收集更多的献血，那么对血液服务来说将是相当大的好处。英国国民健康服务（NHS）血液和移植目前允许男性每12周捐赠一次，女性每16周捐赠一次。相比之下，其他一些欧洲国家允许男性每8周和女性每10周捐赠一次。INTERVAL试验的主要目的是确定献血间隔是否可以安全和可接受地缩短，以优化血液供应，同时保持献血者的健康。INTERVAL是一项随机试验，从NHS血液和移植的所有25个静态中心招募全血供体。2012年6月开始招募约50 000名男性和女性捐献者，2014年6月完成。男性被随机分配到标准的12周、10周和8周的捐赠间隔，而女性被分配到标准的16周、14周和12周的捐赠间隔。将通过干预2年后评估结果的意向治疗分析进行性别特异性比较。主要结果是献血次数。一个关键的次要结果是供体的生活质量，使用简表健康调查进行评估。其他次要终点包括由于低血红蛋白（和其他因素）、铁状态、认知功能、体力活动和供体态度而导致的“去铁”数量。将进行全面的卫生经济分析。INTERVAL试验应能提供有关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。这项研究将提供科学证据，帮助制定英格兰和其他地方的采血政策。当前对照试验ISRCTN 24760606，2012年1月25日。
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. 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.
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DOI：
10.1136/bmj.b2393
发表时间：
2009-06-29
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
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影响因子：
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作者：
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影响因子：
2.9
作者：
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通讯作者：
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影响因子：
3
作者：
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通讯作者：
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作者：
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通讯作者：
Sousa, Nuno