Whole blood transfusion for children with severe malaria

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label randomized controlled trial aims to evaluate the effectiveness of whole blood transfusion in improving survival rates among children aged 6 months to 15 years suffering from severe malaria complicated by thrombocytopenia. The study will recruit 132 participants in Zambia, who will be randomly assigned to receive either whole blood transfusion or standard care without transfusion. The trial is designed to follow participants until hospital discharge or death, providing critical data on the potential benefits of this intervention in a high-risk population. It is nested within a larger observational study focused on severe malaria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \<5 years
* Platelet count ≤100,000/uL
* Hemoglobin \>5 and ≤11 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

Where it's running

• National Health Research and Training Institute
  Ndola, Copperbelt, Zambia Recruiting
• Johns Hopkins Bloomberg School of Public Health
  Baltimore, Maryland, United States Active not recruiting

Study contacts

• Principal investigator: Matthew M Ippolito, MD, PhD — Johns Hopkins University
• Study coordinator: Matthew M Ippolito, MD PhD
• Email: mippolito@jhu.edu
• Phone: 443-287-4809

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.