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RECRUITINGINTERVENTIONAL

Platelet-Directed Whole Blood Transfusion Strategy for Malaria

Clinical and Translational Investigations of Severe Malaria Pathophysiology [Parent Study Protocol]

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Open-label randomized controlled trial to test the effectiveness of whole blood transfusion for improving survival in children with severe malaria complicated by thrombocytopenia.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form obtained from the parent or legal guardian of the participant Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

Whole blood transfusion

Whole blood is sourced from the Zambia National Blood Transfusion Service.

Locations (2)

Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States
Tropical Diseases Research Centre
Ndola, Copperbelt, Zambia