Whole blood versus red cell concentrates for children with severe anaemia: a secondary analysis of the Transfusion and Treatment of African Children (TRACT) trial.
Whole blood versus red cell concentrates for children with severe anaemia: a secondary analysis of the Transfusion and Treatment of African Children (TRACT) trial.
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DOI：
10.1016/s2214-109x(21)00565-9
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发表时间：
2022-03
期刊：
影响因子：
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通讯作者：
TRACT trial study group
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文献类型：
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作者：
George EC;Uyoga S;M'baya B;Kyeyune Byabazair D;Kiguli S;Olupot-Olupot P;Opoka RO;Chagaluka G;Alaroker F;Williams TN;Bates I;Mbanya D;Gibb DM;Walker AS;Maitland K;TRACT trial study group
TRACT试验确定了无并发症贫血（血红蛋白4-6 g/dL）儿童的输血时间，以及第28天死亡率（主要终点）时严重贫血（血红蛋白<6 g/dL）住院儿童的最佳输血量（20 vs 30 mL/kg全血或10 vs 15 mL/kg红细胞浓缩物）。由于有关血液成分安全性的数据很少，我们进行了二次分析，以检查不同包类型（全血与红细胞浓缩物）对临床结局的安全性和有效性。本研究是TRACT试验数据的二次分析，仅限于接受立即输血（使用全血或红细胞浓缩物）的患者。TRACT是一项开放标签、多中心、析因、随机试验，在乌干达的三家医院（Soroti、姆巴莱和Mulago）和马拉维的一家医院（布兰太尔）进行。该试验招募了因严重贫血（血红蛋白<6 g/dL）住院的2个月至12岁儿童。使用的试剂包类型（由血库提供）仅基于当时的可用性。结果是血红蛋白在8小时和180天的恢复，需要回输，住院时间，心脏和呼吸频率的变化，直到第180天，和主要的临床终点（死亡率，直到第28天和第180天，再入院，直到第180天），使用多变量回归模型测量。在2014年9月17日至2017年5月15日期间，3199名患有严重贫血的儿童入组了TRACT试验。在我们的二次分析中考虑了3188名儿童。中位年龄为37个月（IQR 18-64）。全血是3992例输血中1632例（41%）的第一包。接受浓缩细胞或沉淀细胞的患者在8小时的血红蛋白恢复率显著低于接受全血的患者，平均值为1·4 g/dL（95% CI -1统计6至-1统计1）接受30 mL/kg和-1统计3 g/dL的儿童（-1统计5至-1统计0）在接受20 mL/kg浓缩细胞与全血的受试者中，与全血相比，接受30 mL/kg沉降细胞的受试者中为-1 stats 5 g/dL（-1 stats 7至-1 stats 3），接受20 mL/kg沉降细胞的受试者中为-1 stats 0 g/dL（-1 stats 2至-0 stats 9）（总体p<0.0001）。与全血相比，在第一次输血中接受浓缩或沉淀细胞血液的儿童接受第二次输血的几率更高（压积细胞和沉淀细胞的比值比分别为2·32 [95% CI 1·30 ~ 4·12]和2·97 [2·18 ~ 4·05]; p<0·001）和住院时间更长（红细胞压积组风险比为0·94 [95% CI 0·81 ~ 1·10]，红细胞沉降组风险比为0·86 [0·79 ~ 0·94]; p=0·0024）。第一次输血的血液类型与28天或180天的死亡率或因任何原因再次入院之间没有关联。3188名儿童中有823名（26%）出现严重心动过速，2077名（65%）出现呼吸急促，但这些并发症随着时间的推移而消退。没有儿童出现确认的心肺负荷过重的特征。我们的研究表明，使用浓缩或沉淀的细胞而不是全血会导致额外的输血，增加了撒哈拉以南非洲大部分地区对稀缺资源的使用。这些发现对输血和卫生服务具有重大的成本影响。然而，可能需要进行一项比较全血输血和浓缩红细胞输血的临床试验，以告知政策制定者。英国医学研究理事会（MRC）和国际发展部。摘要的法文翻译见补充材料部分。
The TRACT trial established the timing of transfusion in children with uncomplicated anaemia (haemoglobin 4–6 g/dL) and the optimal volume (20 vs 30 mL/kg whole blood or 10 vs 15 mL/kg red cell concentrates) for transfusion in children admitted to hospital with severe anaemia (haemoglobin <6 g/dL) on day 28 mortality (primary endpoint). Because data on the safety of blood components are scarce, we conducted a secondary analysis to examine the safety and efficacy of different pack types (whole blood vs red cell concentrates) on clinical outcomes. This study is a secondary analysis of the TRACT trial data restricted to those who received an immediate transfusion (using whole blood or red cell concentrates). TRACT was an open-label, multicentre, factorial, randomised trial conducted in three hospitals in Uganda (Soroti, Mbale, and Mulago) and one hospital in Malawi (Blantyre). The trial enrolled children aged between 2 months and 12 years admitted to hospital with severe anaemia (haemoglobin <6 g/dL). The pack type used (supplied by blood banks) was based only on availability at the time. The outcomes were haemoglobin recovery at 8 h and 180 days, requirement for retransfusion, length of hospital stay, changes in heart and respiratory rates until day 180, and the main clinical endpoints (mortality until day 28 and day 180, and readmission until day 180), measured using multivariate regression models. Between Sept 17, 2014, and May 15, 2017, 3199 children with severe anaemia were enrolled into the TRACT trial. 3188 children were considered in our secondary analysis. The median age was 37 months (IQR 18–64). Whole blood was the first pack provided for 1632 (41%) of 3992 transfusions. Haemoglobin recovery at 8 h was significantly lower in those who received packed cells or settled cells than those who received whole blood, with a mean of 1·4 g/dL (95% CI –1·6 to –1·1) in children who received 30 mL/kg and –1·3 g/dL (–1·5 to –1·0) in those who received 20 mL/kg packed cells versus whole blood, and –1·5 g/dL (–1·7 to –1·3) in those who received 30 mL/kg and –1·0 g/dL (–1·2 to –0·9) in those who received 20 mL/kg settled cells versus whole blood (overall p<0·0001). Compared to whole blood, children who received blood as packed or settled cells in their first transfusion had higher odds of receiving a second transfusion (odds ratio 2·32 [95% CI 1·30 to 4·12] for packed cells and 2·97 [2·18 to 4·05] for settled cells; p<0·001) and longer hospital stays (hazard ratio 0·94 [95% CI 0·81 to 1·10] for packed cells and 0·86 [0·79 to 0·94] for settled cells; p=0·0024). There was no association between the type of blood supplied for the first transfusion and mortality at 28 days or 180 days, or readmission to hospital for any cause. 823 (26%) of 3188 children presented with severe tachycardia and 2077 (65%) with tachypnoea, but these complications resolved over time. No child developed features of confirmed cardiopulmonary overload. Our study suggests that the use of packed or settled cells rather than whole blood leads to additional transfusions, increasing the use of a scarce resource in most of sub-Saharan Africa. These findings have substantial cost implications for blood transfusion and health services. Nevertheless, a clinical trial comparing whole blood transfusion with red cell concentrates might be needed to inform policy makers. UK Medical Research Council (MRC) and the Department for International Development. For the French translation of the abstract see Supplementary Materials section.