NCT05711485

Platelet-Directed Whole Blood Transfusion Strategy for Malaria

Clinical and Translational Investigations of Severe Malaria Pathophysiology [Parent Study Protocol]

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

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.

Detailed description

The PLATFORM trial is a single-center, open-label randomized controlled trial of whole blood transfusion for severe malaria complicated by thrombocytopenia. The trial will recruit 132 Zambian children 6 months to 15 years old with severe malaria defined according to modified WHO criteria with concomitant thrombocytopenia, defined here as a platelet count ≤75,000/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.

Conditions

• Severe Malaria
• Thrombocytopenia

Interventions

Type	Name	Description
OTHER	Whole blood transfusion	Whole blood is sourced from the Zambia National Blood Transfusion Service.

Timeline

• Start date: 2024-02-24
• Primary completion: 2027-04-30
• Completion: 2028-05-31
• First posted: 2023-02-03
• Last updated: 2025-10-09

Locations

2 sites across 2 countries: United States, Zambia