Donor Health, Sanquin Research, Amsterdam, Netherlands; Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, Amsterdam, Netherlands.
Donor Health, Sanquin Research, Amsterdam, Netherlands; Department of Communication Science, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Lancet. 2024 Jul 6;404(10447):31-43. doi: 10.1016/S0140-6736(24)01085-7. Epub 2024 Jun 13.
Whole-blood donors are at increased risk for iron deficiency and anaemia. The current standard of haemoglobin monitoring is insufficient to ensure the maintenance of proper iron reserves and donor health. We aimed to determine the effects of ferritin-guided donation intervals for blood donor health and blood supply in the Netherlands.
In this stepped-wedge cluster-randomised trial (FIND'EM), the 138 fixed and mobile donation centres in the Netherlands are organised into 29 geographical clusters and the clusters were randomly assigned to four treatment groups, with two groups being further split into two per a protocol amendment. Eligible donors were whole-blood donors who consented for use of their leftover material in the study. Each group was sequentially crossed over from the existing policy (haemoglobin-based screening; control) to a ferritin-guided donation interval policy over a 3-year period. In the intervention groups, in addition to the existing haemoglobin screening, ferritin was measured in all new donors and at every fifth donation in repeat donors. Subsequent donation intervals were extended to 6 months if ferritin concentrations were 15-30 ng/mL and to 12 months if they were less than 15 ng/mL. Outcomes were measured cross-sectionally across all donation centres at four timepoints. Primary outcomes were ferritin and haemoglobin concentrations, iron deficiency, and haemoglobin-based deferrals. We assessed all outcomes by sex and menopausal status and significance for primary outcomes was indicated by a p value of less than 0·0125. This trial is registered in the Dutch trial registry, NTR6738, and is complete.
Between Sept 11, 2017, and Nov 27, 2020, 412 888 whole-blood donors visited a donation centre, and we did measurements on samples from 37 621 donations from 36 099 donors. Over 38 months, ferritin-guided donation intervals increased mean ferritin concentrations (by 0·18 log10 ng/mL [95% CI 0·15-0·22; p<0·0001] in male donors, 0·10 log10 ng/mL [0·06-0·15; p<0·0001] in premenopausal female donors, and 0·17 log10 ng/mL [0·12-0·21; p<0·0001] in postmenopausal female donors) and mean haemoglobin concentrations (by 0·30 g/dL [95% CI 0·22-0·38; p<0·0001] in male donors, 0·12 g/dL [0·03-0·20; p<0·0074] in premenopausal female donors, and 0·16 g/dL [0·05-0·27; p<0·0044] in postmenopausal female donors). Iron deficiency decreased by 36-38 months (odds ratio [OR] 0·24 [95% CI 0·18-0·31; p<0·0001] for male donors, 0·49 [0·37-0·64; p<0·0001] for premenopausal female donors, and 0·24 [0·15-0·37; p<0·0001] for postmenopausal female donors). At 36-38 months, haemoglobin-based deferral decreased significantly in male donors (OR at 36-38 months 0·21 [95% CI 0·10-0·40, p<0·0001]) but not significantly in premenopausal or postmenopausal female donors (0·81 [0·54-1·20; p=0·29] and 0·50 [95% CI 0·25-0·98; p=0·051], respectively).
Ferritin-guided donation intervals significantly improved haemoglobin and ferritin concentrations and significantly decreased iron deficiency over the study period. Haemoglobin-based deferrals decreased significantly for male donors, but not female donors. Although this intervention is overall beneficial for maintenance of iron and haemoglobin concentrations in donors, increased efforts are needed to recruit and retain donors.
The Sanquin Research Programming Committee.
全血献血者铁缺乏和贫血的风险增加。目前的血红蛋白监测标准不足以确保适当的铁储备和献血者的健康。我们旨在确定铁蛋白指导的献血间隔对荷兰献血者健康和血液供应的影响。
在这项逐步楔形聚类随机试验（FIND'EM）中，荷兰的 138 个固定和流动献血中心分为 29 个地理集群，集群被随机分配到四个治疗组，其中两组根据协议修正案进一步分为两组。合格的献血者是全血献血者，他们同意在研究中使用他们的剩余材料。每个组在三年内从现有的政策（血红蛋白筛查；对照组）顺序过渡到铁蛋白指导的献血间隔政策。在干预组中，除了现有的血红蛋白筛查外，所有新献血者和重复献血者每五次献血时都要测量铁蛋白。如果铁蛋白浓度为 15-30ng/ml，则将随后的献血间隔延长至 6 个月，如果浓度低于 15ng/ml，则延长至 12 个月。在四个时间点，通过所有献血中心的横断面测量来评估结果。主要结果是铁蛋白和血红蛋白浓度、缺铁和基于血红蛋白的延期。我们通过性别和绝经状态评估了所有结果，主要结果的显著性以 p 值小于 0.0125 表示。该试验在荷兰试验注册中心 NTR6738 注册，现已完成。
在 2017 年 9 月 11 日至 2020 年 11 月 27 日期间，412888 名全血献血者访问了一个献血中心，我们对 36099 名献血者的 37621 次献血样本进行了测量。在 38 个月的时间里，铁蛋白指导的献血间隔增加了平均铁蛋白浓度（男性献血者增加 0.18log10ng/ml[95%CI 0.15-0.22;p<0.0001]，绝经前女性献血者增加 0.10log10ng/ml[0.06-0.15;p<0.0001]，绝经后女性献血者增加 0.17log10ng/ml[0.12-0.21;p<0.0001]）和平均血红蛋白浓度（男性献血者增加 0.30g/dl[95%CI 0.22-0.38;p<0.0001]，绝经前女性献血者增加 0.12g/dl[0.03-0.20;p<0.0074]，绝经后女性献血者增加 0.16g/dl[0.05-0.27;p<0.0044]）。缺铁减少了 36-38 个月（男性献血者的比值比[OR]为 0.24[95%CI 0.18-0.31;p<0.0001]，绝经前女性献血者为 0.49[0.37-0.64;p<0.0001]，绝经后女性献血者为 0.24[0.15-0.37;p<0.0001]）。在 36-38 个月时，男性献血者的基于血红蛋白的延期显著减少（36-38 个月时的 OR 为 0.21[95%CI 0.10-0.40;p<0.0001]），但绝经前和绝经后女性献血者的变化不显著（0.81[0.54-1.20;p=0.29]和 0.50[95%CI 0.25-0.98;p=0.051]）。
铁蛋白指导的献血间隔显著改善了血红蛋白和铁蛋白浓度，并在研究期间显著降低了缺铁。男性献血者的基于血红蛋白的延期显著减少，但女性献血者的变化不显著。尽管这种干预措施总体上有利于维持献血者的铁和血红蛋白浓度，但需要进一步努力招募和留住献血者。
荷兰 Sanquin 研究计划委员会。
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