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NCT05711485 | Recruiting | Severe Malaria

Platelet-Directed Whole Blood Transfusion Strategy for Malaria
Sponsor:

Johns Hopkins Bloomberg School of Public Health

Brief 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.

Condition or disease

Severe Malaria

Thrombocytopenia

Intervention/treatment

Whole blood transfusion

Phase

Not Applicable

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.}}

Study Type : Interventional
Estimated Enrollment : 132 participants
Masking : Double
Primary Purpose : Supportive Care
Official Title : Clinical and Translational Investigations of Severe Malaria Pathophysiology [Parent Study Protocol]
Actual Study Start Date : February 24, 2024
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : February 28, 2025
Arm Intervention/treatment

Experimental: Whole blood transfusion

Whole blood transfusion x1 (20 mL/kg)

No Intervention: Control

Standard-of-care
Ages Eligible for Study: 6 Months to 59 Months
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Platelet-Directed Whole Blood Transfusion Strategy for Malaria

Location Details

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Platelet-Directed Whole Blood Transfusion Strategy for Malaria

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Maryland

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States, 21205

Recruiting

Zambia, Copperbelt

Tropical Diseases Research Centre

Dollar, Copperbelt, Zambia,