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Transfusion and Treatment of severe anaemia in African children (TRACT): a study protocol for a randomised controlled
Ayub Mpoya1, Sarah Kiguli2, Peter Olupot-Olupot3
1KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya. AMpoya@kemri-wellcome.org.
Insights
This study investigates optimal transfusion and treatment strategies for severe anaemia in African children, aiming to reduce mortality and relapse. Findings could lead to a cost-effective intervention bundle for hospitalized children.
Area of Science:
- Pediatric critical care
- Hematology
- Infectious disease epidemiology
Background:
- Severe anemia is a leading cause of pediatric hospital admission in sub-Saharan Africa, with limited evidence for current treatment guidelines.
- Existing treatment strategies, including conservative transfusion policies, result in high in-hospital and 6-month mortality rates (9-10% and 6% respectively).
- There is a critical need for a definitive trial to establish optimal transfusion and treatment protocols to mitigate both early and delayed mortality and disease relapse.
Purpose of the Study:
- To evaluate the effectiveness of different transfusion strategies in reducing short-term and long-term mortality and morbidity in children with severe anemia.
- To assess the impact of post-discharge nutritional supplementation and antibiotic prophylaxis on outcomes for these children.
- To establish a comprehensive intervention bundle to improve survival rates and reduce relapse in hospitalized African children with severe anemia.
Main Methods:
- A multicenter randomized controlled trial (TRACT) involving 3954 children aged 2 months to 12 years with severe anemia (hemoglobin < 6 g/dl).
- A factorial trial design (3x2x2) simultaneously evaluating three interventions: transfusion strategies (liberal, conservative, none), post-discharge supplementation (multivitamin/multimineral vs. routine care), and antibiotic prophylaxis (cotrimoxazole vs. none).
- Children will be enrolled over 2 years in Uganda and Malawi, with a 6-month follow-up period. Primary outcomes include cumulative mortality at 4 weeks (transfusion) and 6 months (nutrition/prophylaxis).
Main Results:
- The trial is currently ongoing, with enrollment initiated in September 2014.
- Primary outcome is cumulative mortality at 4 weeks for transfusion comparisons and 6 months for nutritional support/antibiotic prophylaxis comparisons.
- Secondary outcomes encompass mortality, morbidity (hematological, nutritional, infectious), safety, and cost-effectiveness.
Conclusions:
- The trial aims to identify a cost-effective and widely implementable intervention bundle for severe anemia in African children.
- Successful identification of optimal strategies could significantly reduce annual mortality among hospitalized children with severe anemia.
- This research addresses a critical gap in evidence, potentially transforming the management of severe anemia in resource-limited settings.
Background:
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.
Methods/Design:
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.
Discussion:
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.
Trial Registration:
Current Controlled Trials ISRCTN84086586 , Approved 11 February 2013.
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