Clinical and Translational Investigations of Severe Malaria Pathophysiology [Parent Study Protocol]
Johns Hopkins Bloomberg School of Public Health
Summary
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. T…
Eligibility
- Age range
- 0–4 years
- Sex
- All
- Healthy volunteers
- No
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 catc…
Interventions
- OtherWhole blood transfusion
Whole blood is sourced from the Zambia National Blood Transfusion Service.
Locations (2)
- Johns Hopkins Bloomberg School of Public HealthBaltimore, Maryland
- Tropical Diseases Research CentreNdola, Copperbelt