Efficiency and safety of varying the frequency of whole blood donation (INTERVAL): a randomised trial of 45 000 donors.
Efficiency and safety of varying the frequency of whole blood donation (INTERVAL): a randomised trial of 45 000 donors.
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DOI：
10.1016/s0140-6736(17)31928-1
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发表时间：
2017-11-25
期刊：
影响因子：
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通讯作者：
INTERVAL Trial Group
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作者：
Di Angelantonio E;Thompson SG;Kaptoge S;Moore C;Walker M;Armitage J;Ouwehand WH;Roberts DJ;Danesh J;INTERVAL Trial Group
对全血捐献频率的限制主要是为了保护捐献者的健康。然而，在允许的最高献血频率方面，各血液服务机构存在很大差异。我们将英国的标准做法与其他国家使用的较短的献血间隔进行了比较。在这项平行组、务实的随机试验中，我们从英国英格兰的25个中心招募了18岁或以上的全血捐献者。通过使用基于计算机的算法，男性被随机分配（1：1：1）到12周（标准）与10周与8周的捐赠间隔，女性被随机分配（1：1：1）到16周（标准）与14周与12周的间隔。参与者不对分配的干预组设盲。主要结局是2年内的献血次数。与安全性相关的次要结局是生活质量、可能与献血相关的症状、体力活动、认知功能、血红蛋白和铁蛋白浓度以及由于低血红蛋白引起的去铁化。该试验已在ISRCTN注册，编号为ISRCTN 24760606，正在进行中，但不再招募参与者。在2012年6月11日至2014年6月15日期间招募了45263名全血供体（22466名男性，22797名女性）。 分析了45042（99.5%）名参与者的数据。 男性随机分配到12周（n=7452）、10周（n=7449）和8周（n=7456）组;女性随机分配到16周（n=7550）、14周（n =7567）和12周（n=7568）组。在男性中，与12周组相比，8周组中每名献血者在2年内采集的平均血液量增加了1.69个单位（95% CI 1.59 - 1.80;约795 mL），10周组中增加了0.79个单位（0.69 - 0.88;约370 mL）（两者均为p<0.0001）。在女性中，与16周组相比，12周组增加了0.84个单位（95% CI 0.76 - 0.91;约395 mL），14周组增加了0.46个单位（0.39 - 0.53;约215 mL）（两者均为p<0.0001）。在随机分组中，没有观察到生活质量、体力活动或认知功能的显著差异。然而，与标准频率组相比，更频繁的献血导致更多的献血相关症状（如疲劳、呼吸困难、头晕和不宁腿，尤其是男性[对于所有列出的症状]），更低的平均血红蛋白和铁蛋白浓度，以及更多的低血红蛋白去铁（每种p<0.0001）。在2年多的时间里，比英国标准做法更频繁的献血收集了更多的血液，对献血者的生活质量、身体活动或认知功能没有重大影响，但导致更多的献血相关症状、缺铁和缺铁。NHS血液和移植，国家健康研究所，英国医学研究理事会和英国心脏基金会。
Limits on the frequency of whole blood donation exist primarily to safeguard donor health. However, there is substantial variation across blood services in the maximum frequency of donations allowed. We compared standard practice in the UK with shorter inter-donation intervals used in other countries. In this parallel group, pragmatic, randomised trial, we recruited whole blood donors aged 18 years or older from 25 centres across England, UK. By use of a computer-based algorithm, men were randomly assigned (1:1:1) to 12-week (standard) versus 10-week versus 8-week inter-donation intervals, and women were randomly assigned (1:1:1) to 16-week (standard) versus 14-week versus 12-week intervals. Participants were not masked to their allocated intervention group. The primary outcome was the number of donations over 2 years. Secondary outcomes related to safety were quality of life, symptoms potentially related to donation, physical activity, cognitive function, haemoglobin and ferritin concentrations, and deferrals because of low haemoglobin. This trial is registered with ISRCTN, number ISRCTN24760606, and is ongoing but no longer recruiting participants. 45 263 whole blood donors (22 466 men, 22 797 women) were recruited between June 11, 2012, and June 15, 2014. Data were analysed for 45 042 (99·5%) participants. Men were randomly assigned to the 12-week (n=7452) versus 10-week (n=7449) versus 8-week (n=7456) groups; and women to the 16-week (n=7550) versus 14-week (n=7567) versus 12-week (n=7568) groups. In men, compared with the 12-week group, the mean amount of blood collected per donor over 2 years increased by 1·69 units (95% CI 1·59–1·80; approximately 795 mL) in the 8-week group and by 0·79 units (0·69–0·88; approximately 370 mL) in the 10-week group (p<0·0001 for both). In women, compared with the 16-week group, it increased by 0·84 units (95% CI 0·76–0·91; approximately 395 mL) in the 12-week group and by 0·46 units (0·39–0·53; approximately 215 mL) in the 14-week group (p<0·0001 for both). No significant differences were observed in quality of life, physical activity, or cognitive function across randomised groups. However, more frequent donation resulted in more donation-related symptoms (eg, tiredness, breathlessness, feeling faint, dizziness, and restless legs, especially among men [for all listed symptoms]), lower mean haemoglobin and ferritin concentrations, and more deferrals for low haemoglobin (p<0·0001 for each) than those observed in the standard frequency groups. Over 2 years, more frequent donation than is standard practice in the UK collected substantially more blood without having a major effect on donors' quality of life, physical activity, or cognitive function, but resulted in more donation-related symptoms, deferrals, and iron deficiency. NHS Blood and Transplant, National Institute for Health Research, UK Medical Research Council, and British Heart Foundation.