Platelet-Directed Whole Blood Transfusion Strategy for Malaria
United States, Zambia132 participantsStarted 2024-02-24
Plain-language 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.
Who can participate
Age range6 Months – 59 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Incidence of all-cause mortality
Timeframe: Up to hospital discharge or in-hospital death, up to 28 days on average
Trial details
NCT IDNCT05711485
SponsorJohns Hopkins Bloomberg School of Public Health