Overview
Open-label randomized controlled trial to test the effectiveness of whole blood transfusion for improving survival in children with severe malaria complicated by thrombocytopenia.
Description
The PLATFORM trial is a single-center, open-label randomized controlled trial of whole blood transfusion for severe malaria complicated by thrombocytopenia. The trial will recruit 132 Zambian children 6 months to 15 years old with severe malaria defined according to modified WHO criteria with concomitant thrombocytopenia, defined here as a platelet count ≤75,000/uL, who do not otherwise have a current indication for transfusion according to current guidelines. Children will be randomized 1:1 to whole blood transfusion or no whole blood transfusion and followed to hospital discharge or death. The trial is nested within the Children and Adults with Severe Malaria (CHASM) cohort, a prospective observational study of severe malaria.
Eligibility
Inclusion Criteria:
- Age <5 years
- Platelet count ≤75,000/uL
- Hemoglobin >5 and ≤9 g/dL
- P. falciparum parasitemia ≥500 parasites/uL
- Diagnosis of severe malaria meeting World Health Organization (WHO) criteria
- Ability and willingness of the legal guardian to comply with study protocol for the duration of the study
- Residence within health clinic catchment area
- Signed informed consent obtained from the parent or legal guardian of the participant
Exclusion Criteria:
- Residence in foster care or children otherwise under government supervision
- Residence outside the hospital catchment area, or plan to leave the area
- Presence of any other condition or abnormality which, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data
- Any contraindication to whole blood transfusion