Whole blood transfusion for children with severe malaria
Clinical and Translational Investigations of Severe Malaria Pathophysiology [Parent Study Protocol]
This study is testing if giving whole blood transfusions can help children aged 6 months to 15 years with severe malaria live longer compared to standard care without transfusions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 6 Months to 59 Months |
| Sex | All |
| Sponsor | Johns Hopkins Bloomberg School of Public Health Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT05711485 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are Zambian children aged 6 months to 15 years with severe malaria and a platelet count of 75,000/uL or lower.
Not a fit: Patients who may not benefit include those with other serious health conditions or contraindications to blood transfusion.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates in children with severe malaria and low platelet counts.
How similar studies have performed: Other studies have explored blood transfusion strategies in severe malaria, but this specific approach is novel and untested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland and 1 other locations
- Johns Hopkins Bloomberg School of Public Health — Baltimore, Maryland, United States (Not_yet_recruiting)
- Tropical Diseases Research Centre — Ndola, Copperbelt, Zambia (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.