An interventional study of Whole blood transfusion in Severe Malaria and Thrombocytopenia, sponsored by Johns Hopkins Bloomberg School of Public Health. Recruiting at 2 sites in 2 countries. Open to participants aged 1 Month to 59 Months. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Supportive care
Open-label randomized controlled trial to test the effectiveness of whole blood transfusion for improving survival in children with severe malaria complicated by thrombocytopenia.
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.
Exclusion Criteria:
Whole blood transfusion x1 (20 mL/kg)
Other: Whole blood transfusion
Standard-of-care
Whole blood is sourced from the Zambia National Blood Transfusion Service.
Incidence of all-cause mortality
Death due to any cause
Time frame: Up to hospital discharge or in-hospital death, up to 28 days on average
Change in hemoglobin (Hb)
The difference in Hb concentration between baseline (pre-transfusion) and post-transfusion
Time frame: Pre- and post-transfusion, comparing baseline measurements to measurements taken 2 hours after transfusion completion and 24 hours later. For the Control arm, measurements will be made at baseline and Study Hour 6 ±2 and 24 hours later
Change in platelet count
The difference in the platelet count between baseline (pre-transfusion) and post-transfusion
Time frame: Pre- and post-transfusion, comparing baseline measurements to measurements taken 2 hours after transfusion completion and 24 hours later. For the Control arm, measurements will be made at baseline and Study Hour 6 ±2 and 24 hours later
Change in white blood cell (WBC) count
The difference in the WBC count between baseline (pre-transfusion) and post-transfusion
Time frame: Pre- and post-transfusion, comparing baseline measurements to measurements taken 2 hours after transfusion completion and 24 hours later. For the Control arm, measurements will be made at baseline and Study Hour 6 ±2 and 24 hours later
Incidence of transfusion reaction
Transfusion reactions (e.g., hypersensitivity, TACO, TRALI) graded on severity and likeliness of being related to transfusion
Time frame: During or after transfusion, up to the day of hospital discharge or in-hospital death, up to 28 days on average
Length of hospitalization
Interval in days from date of admission to date of discharge/death
Time frame: Up to hospital discharge or in-hospital death, up to 28 days on average
Parasite clearance
Time to microscopic conversion to negative
Time frame: 0-72 hours, measured every 12±2 hours
Plan to share: Yes — Data will be made available to other researchers upon reasonable request.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Johns Hopkins Bloomberg School of Public Health