Platelet-Directed Whole Blood Transfusion Strategy for Malaria (PLATFORM)

Johns Hopkins Bloomberg School of Public Health

Status: Enrolling

Conditions: Thrombocytopenia; Severe Malaria

Treatments: Other: Whole blood transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05711485

IRB00015011 (Other Identifier)

Details and patient eligibility

About

Open-label randomized controlled trial to test the effectiveness of whole blood transfusion for improving survival in children with severe malaria complicated by thrombocytopenia.

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups

Whole blood transfusion

Experimental group

Description:

Whole blood transfusion x1 (20 mL/kg)

Treatment:

Other: Whole blood transfusion

Control

No Intervention group

Description:

Standard-of-care