NCT05711485NARecruiting

Platelet-Directed Whole Blood Transfusion Strategy for Malaria

Johns Hopkins Bloomberg School of Public Health

Start Date

2/24/2024

Completion Date

5/31/2028

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.

Detailed Description

The PLATFORM trial is a multi-center, single-blinded, randomized controlled trial of whole blood transfusion for severe malaria complicated by thrombocytopenia. The trial will recruit 240 Zambian children 1 month to 5 years old with severe malaria defined according to modified WHO criteria with concomitant thrombocytopenia, defined here as a platelet count ≤100,000/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 Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * Age \<5 years * Platelet count ≤100,000/uL * Hemoglobin \>5 and ≤11 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

Interventions

OTHER

Whole blood transfusion

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Conditions

Severe MalariaThrombocytopenia

Locations

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland 21205

United States

National Health Research and Training Institute

Ndola, Copperbelt

Zambia