Transfusion and Treatment of severe anaemia in African children (TRACT): a study protocol for a randomised controlled trial.
Transfusion and Treatment of severe anaemia in African children (TRACT): a study protocol for a randomised controlled trial.
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DOI：
10.1186/s13063-015-1112-4
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发表时间：
2015-12-29
期刊：
影响因子：
2.5
通讯作者：
Maitland K
中科院分区：
文献类型：
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作者：
Mpoya A;Kiguli S;Olupot-Olupot P;Opoka RO;Engoru C;Mallewa M;Chimalizeni Y;Kennedy N;Kyeyune D;Wabwire B;M'baya B;Bates I;Urban B;von Hensbroek MB;Heyderman R;Thomason MJ;Uyoga S;Williams TN;Gibb DM;George EC;Walker AS;Maitland K
在撒哈拉以南非洲，传染病和营养不足很常见，严重贫血是儿科住院的常见原因，但支持目前治疗建议的证据有限。为了避免过度使用血液制品，世界卫生组织倡导保守的输血政策，并建议出院时使用铁、叶酸和抗蠕虫药物。结果并不令人满意，住院死亡率(9-10%)、6个月死亡率和复发率(6%)都很高。有必要进行明确的试验，以确定最佳输血和治疗策略，以防止早期和延迟死亡和复发。TRADE是一项多中心随机对照试验，有3954名2个月至12岁的儿童因严重贫血(血红蛋白 <； 6g/dl)入院。儿童将在乌干达和马拉维的4个中心接受为期2年的登记，并跟踪6个月。该试验将同时评估(采用3×2×2设计的析因试验)降低非洲儿童严重贫血入院后短期和长期死亡率和发病率的3种方法。该试验将比较：(I)R1：自由输血(30毫升/千克全血)与保守输血(20毫升/千克)与不输血(对照)。对照组仅适用于无并发症的严重贫血儿童(血红蛋白4-6g/dl)；(Ii)R2：出院后服用多种维生素多种矿物质补充剂(包括叶酸和铁)与常规护理(叶酸和铁)，为期3个月；(Iii)R3：出院后预防复方新诺明3个月，与不预防相比。所有的随机选择都是开放的。参加审判从2014年9月开始，目前正在进行中。主要结果是输液策略比较的累积死亡率为4周，营养支持/抗生素预防比较的累积死亡率为6个月。次要结果包括死亡率、发病率(血液学纠正、营养和感染性)、安全性和成本效益。如果试验证实，如果广泛实施，一套针对严重贫血的直接和下游后果的廉价且可广泛获得的有效干预措施，可能会大幅降低每年因严重贫血而住院的大量非洲儿童的死亡率。当前对照试验ISRCTN84086586，批准于2013年2月11日
In sub-Saharan Africa, where infectious diseases and nutritional deficiencies are common, severe anaemia is a common cause of paediatric hospital admission, yet the evidence to support current treatment recommendations is limited. To avert overuse of blood products, the World Health Organisation advocates a conservative transfusion policy and recommends iron, folate and anti-helminthics at discharge. Outcomes are unsatisfactory with high rates of in-hospital mortality (9–10 %), 6-month mortality and relapse (6 %). A definitive trial to establish best transfusion and treatment strategies to prevent both early and delayed mortality and relapse is warranted. TRACT is a multicentre randomised controlled trial of 3954 children aged 2 months to 12 years admitted to hospital with severe anaemia (haemoglobin < 6 g/dl). Children will be enrolled over 2 years in 4 centres in Uganda and Malawi and followed for 6 months. The trial will simultaneously evaluate (in a factorial trial with a 3 x 2 x 2 design) 3 ways to reduce short-term and longer-term mortality and morbidity following admission to hospital with severe anaemia in African children. The trial will compare: (i) R1: liberal transfusion (30 ml/kg whole blood) versus conservative transfusion (20 ml/kg) versus no transfusion (control). The control is only for children with uncomplicated severe anaemia (haemoglobin 4–6 g/dl); (ii) R2: post-discharge multi-vitamin multi-mineral supplementation (including folate and iron) versus routine care (folate and iron) for 3 months; (iii) R3: post-discharge cotrimoxazole prophylaxis for 3 months versus no prophylaxis. All randomisations are open. Enrolment to the trial started September 2014 and is currently ongoing. Primary outcome is cumulative mortality to 4 weeks for the transfusion strategy comparisons, and to 6 months for the nutritional support/antibiotic prophylaxis comparisons. Secondary outcomes include mortality, morbidity (haematological correction, nutritional and infectious), safety and cost-effectiveness. If confirmed by the trial, a cheap and widely available ‘bundle’ of effective interventions, directed at immediate and downstream consequences of severe anaemia, could lead to substantial reductions in mortality in a substantial number of African children hospitalised with severe anaemia every year, if widely implemented. Current Controlled Trials ISRCTN84086586, Approved 11 February 2013