Transfusion and treatment of severe anaemia in African children trial

• Register: ISRCTN
• Last refreshed on: 1 March 2022
• Main ID: ISRCTN84086586
• Date of registration: 11/02/2013
• Prospective Registration: Yes
• Primary sponsor: Imperial College London (UK)
• Public title: Transfusion and treatment of severe anaemia in African children trial
• Scientific title: TRansfusion and TReatment of severe Anaemia in African Children: a randomised controlled Trial
• Date of first enrolment: 01/09/2014
• Target sample size: 3954
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN84086586
• Study type: Interventional
• Study design: Randomised controlled factorial trial with a 3x2x2 design (Treatment)
• Phase: Phase III

Countries of recruitment

Malawi, Uganda

Contacts

• Name: Kathryn Maitland

Key inclusion & exclusion criteria

Inclusion criteria:
Children will be recruited at the point of hospital admission
1. Aged 2 months to 12 years
2. Severe anaemia (SA) (Hb<6g/dl) within 2h of admission to hospital
3. Carer willing/able to provide consent

Exclusion criteria:
1. Malignancy
2. Surgery
3. Acute trauma
4. Signs of bi-ventricular heart failure


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Severe anaemia
Haematological Disorders
Nutritional anaemias

Intervention(s)

The trial will have a factorial design with 3 randomisations, each to address one of the potential approaches to reducing mortality and morbidity in children with SA:

R1: Immediate liberal transfusion (30ml/kg) versus conservative transfusion (20ml/kg) versus no transfusion (last strategy only for children with uncomplicated SA and a Hb 4-6 g/dl).

R2: Post-discharge multi-vitamin multi-mineral (MVMM) supplementation (which includes folate and iron) versus routine care (folate and iron) for 3 months.

R3: Post-discharge cotrimoxazole prophylaxis versus no prophylaxis for 3 months.

R1 addresses both conservative aspects of current guidelines: "whether to give" in uncomplicated SA (4-6g/dl without complications), and "how much to give" in all children with SA. The transfusion and post-discharge interventions (R2 and R3) will be open-label for reasons of practicality and compliance.

Primary Outcome(s)

Cumulative mortality to 4 weeks for the transfusion strategy comparison, and to 6 months for the nutritional support/antibiotic prophylaxis comparison

Secondary Outcome(s)

1. Mortality at 48 hours, 28 days, 90 day and 180 days (cumulative) (where not the primary outcome).
2. Morbidity: endpoints relating to the specific mechanisms of action of each intervention:
2.1. Re-admission to hospital
2.2. Proportion achieving correction of anaemia (defined by WHO as Hb>9g/dl) at 48 hours, 28 days, 90 day and 180 days
2.3. Development of new profound anaemia (Hb<4g/dl) during acute admission or development of severe anaemia (Hb<6g/dl) post discharge
3. Nutrition: changes in weight and MUAC at 90 day and 180 days
4. Anti-infection: changes in inflammatory markers (CRP, PCT), incidence of bacterial infections and malaria at 28 days, 90 day and 180 days

Secondary ID(s)

P39233, 203077/Z/16/Z

Source(s) of Monetary Support

Medical Research Council (MRC) and Department for International Development (through a concordat with MRC), United Kingdom Grant Number MR/J012483/1, Wellcome Trust

Ethics review

Status:
Approval date:
Contact:

1. Imperial College Research Ethics Committee (ICREC) 13/01/2011 2. Makerere University School of Medicine research ethics committee (SOMREC), 27/03/2013, #REC ref: 2013-050 3. University of Malawi College of Medicine research and ethics committee (COMREC), 08/08/2013, ref: P.03/13/1365

Results

• Results available: Yes
• Date Completed: 30/12/2019