RecruitingNot ApplicableNCT05711485
Platelet-Directed Whole Blood Transfusion Strategy for Malaria
Clinical and Translational Investigations of Severe Malaria Pathophysiology [Parent Study Protocol]
Sponsor
Johns Hopkins Bloomberg School of Public Health
Enrollment
132 participants
Start Date
Feb 24, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 6 MonthsMax Age: 59 Months
Inclusion Criteria8
- 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 Criteria4
- 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
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Interventions
OTHERWhole blood transfusion
Whole blood is sourced from the Zambia National Blood Transfusion Service.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05711485
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