RecruitingNot Applicable

Platelet-Directed Whole Blood Transfusion Strategy for Malaria

United States, Zambia132 participantsStarted 2024-02-24

Plain-language 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.

Who can participate

Age range

6 Months – 59 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of all-cause mortality

Timeframe: Up to hospital discharge or in-hospital death, up to 28 days on average

Trial details

NCT IDNCT05711485

SponsorJohns Hopkins Bloomberg School of Public Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Matthew M Ippolito, MD PhD

443-287-4809 mippolito@jhu.edu

View on ClinicalTrials.gov More Severe Malaria trials

Who can participate

Age range

6 Months – 59 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.