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.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 132 is below the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 42 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Not enrolling at this site.
Plan to share: Yes — Data will be made available to other researchers upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Approx. 1-2 years after data collection
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