Safety and efficacy of allogeneic umbilical cord red blood cell transfusion for children with severe anaemia in a Kenyan hospital: an open-label single-arm trial.
Safety and efficacy of allogeneic umbilical cord red blood cell transfusion for children with severe anaemia in a Kenyan hospital: an open-label single-arm trial.
复制标题
DOI：
10.1016/s2352-3026(15)00005-8
复制
发表时间：
2015-03
期刊：
影响因子：
--
通讯作者：
Bates I
中科院分区：
文献类型：
--
作者：
Hassall OW;Thitiri J;Fegan G;Hamid F;Mwarumba S;Denje D;Wambua K;Mandaliya K;Maitland K;Bates I
在撒哈拉以南非洲地区，儿童经常因严重贫血而入院，需要紧急输血，但往往无法获得血液。当传统血液供应不足时，同种异体脐带血可能是一种可行的替代方案。本研究的目的是评估严重贫血儿童脐带血输注的安全性和有效性。 2007年6月26日至2008年5月20日期间，肯尼亚基利菲地区医院收治了413名需要紧急输血的儿童。其中，87 名儿童符合我们的研究资格，即年龄小于 12 岁、没有危重疾病迹象、血红蛋白不超过 100 g/L（如果年龄不超过 3 个月）或 40 g/L 或以下（如果年龄超过 3 个月）。脐带血是在蒙巴萨海岸省总医院捐赠的，并进行了输血传播感染和细菌污染的筛查。红细胞垂直储存在 2–6°C 下以进行沉淀。输血后，密切监测儿童的不良事件，并随访 28 天。主要结果指标是与输血相关的不良反应的频率和性质。次要结果是输血后 24 小时和 28 天的血红蛋白浓度与输血前水平相比的变化。该试验已在 ISRCTN.com 上注册，编号 ISRCTN66687527。在符合该研究资格的 87 名儿童中，有 24 名儿童无法获得脐带血，六名护理人员拒绝同意，两名儿童在输血前退出。因此，55 名儿童接受了 74 次捐赠的脐带红细胞。 10 名 (18%) 儿童发生了 10 起严重不良事件，43 名 (78%) 儿童发生了 94 起不良事件；最常见的不良事件是贫血（n=14）、体重减轻（n=12）和呕吐（n=10）。独立专家小组判断这些不良事件均不是可能或肯定由脐带血输注引起的（单侧 97·5% CI 0–6·5）。输血后 24 小时血红蛋白平均增加 26 g/L (IQR 21-31)，输血后 29 天 (28-35) 平均增加 50 g/L (10-68)。这些初步数据表明，脐带血可能是撒哈拉以南非洲儿童输血的重要补充血液来源。需要进一步的研究来比较脐带血与传统成人捐献血液用于输血的安全性和有效性。与成本、基础设施和规模扩大相关的挑战也需要调查。惠康信托。
In sub-Saharan Africa, children are frequently admitted with severe anaemia needing an urgent blood transfusion, but blood is often unavailable. When conventional blood supplies are inadequate, allogeneic umbilical cord blood could be a feasible alternative. The aim of this study was to assess the safety and efficacy of cord blood transfusion in children with severe anaemia. Between June 26, 2007, and May 20, 2008, 413 children needing an urgent blood transfusion were admitted to Kilifi District Hospital in Kenya. Of these, 87 children were eligible for our study—ie, younger than 12 years, no signs of critical illness, and haemoglobin 100 g/L or lower (if aged 3 months or younger) or 40 g/L or lower (if older than 3 months). Cord blood was donated at Coast Provincial General Hospital, Mombasa, and screened for transfusion-transmitted infections and bacterial contamination. Red blood cells were stored vertically at 2–6°C to enable sedimentation. After transfusion, children were monitored closely for adverse events and followed up for 28 days. The primary outcome measure was the frequency and nature of adverse reactions associated with the transfusion. Secondary outcomes were the changes in haemoglobin concentrations 24 h and 28 days after transfusion, compared with pretransfusion levels. This trial is registered on ISRCTN.com, number ISRCTN66687527. Of the 87 children eligible for the study, cord blood was unavailable for 24, six caregivers declined consent, and two children were withdrawn before transfusion. Therefore, 55 children received umbilical cord red blood cells from 74 donations. Ten (18%) children had ten serious adverse events and 43 (78%) had 94 adverse events; the most frequent adverse events were anaemia (n=14), weight loss (n=12), and vomiting (n=10). An independent expert panel judged none of these adverse events to be probably or certainly caused by the cord blood transfusion (one-sided 97·5% CI 0–6·5). Haemoglobin increased by a median of 26 g/L (IQR 21–31) 24 h after transfusion and by 50 g/L (10–68) a median of 29 days (28–35) after transfusion. These preliminary data suggest that cord blood could be an important supplementary source of blood for transfusion in children in sub-Saharan Africa. Further studies are needed to compare the safety and efficacy of cord blood with conventional adult-donated blood for transfusions. Challenges associated with cost, infrastructure, and scale up also need investigating. Wellcome Trust.