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NCT Number: NCT05711485

Platelet-Directed Whole Blood Transfusion Strategy for Malaria

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

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Key information

Conditions

Severe Malaria Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Thrombocytopenia Vector Borne Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole blood transfusion

Other

Whole blood is sourced from the Zambia National Blood Transfusion Service.

Primary outcomes

  1. Incidence of all-cause mortality

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

    Death due to any cause

Secondary outcomes

  1. Change in hemoglobin (Hb)

    Time frame: Pre- and post-transfusion, comparing baseline measurements to measurements taken 2 hours after transfusion completion and 24 hours later. For the Control arm, measurements will be made at baseline and Study Hour 6 ±2 and 24 hours later

    The difference in Hb concentration between baseline (pre-transfusion) and post-transfusion

  2. Change in platelet count

    Time frame: Pre- and post-transfusion, comparing baseline measurements to measurements taken 2 hours after transfusion completion and 24 hours later. For the Control arm, measurements will be made at baseline and Study Hour 6 ±2 and 24 hours later

    The difference in the platelet count between baseline (pre-transfusion) and post-transfusion

  3. Change in white blood cell (WBC) count

    Time frame: Pre- and post-transfusion, comparing baseline measurements to measurements taken 2 hours after transfusion completion and 24 hours later. For the Control arm, measurements will be made at baseline and Study Hour 6 ±2 and 24 hours later

    The difference in the WBC count between baseline (pre-transfusion) and post-transfusion

  4. Incidence of transfusion reaction

    Time frame: During or after transfusion, up to the day of hospital discharge or in-hospital death, up to 28 days on average

    Transfusion reactions (e.g., hypersensitivity, TACO, TRALI) graded on severity and likeliness of being related to transfusion

  5. Length of hospitalization

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

    Interval in days from date of admission to date of discharge/death

  6. Parasite clearance

    Time frame: 0-72 hours, measured every 12±2 hours

    Time to microscopic conversion to negative

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew M Ippolito, MD PhD

CONTACT

[email protected]

443-287-4809

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Johns Hopkins University
  • Tropical Diseases Research Centre
  • University of California, San Francisco
  • University of Maryland

Registry information

Official study title

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

Acronym: PLATFORM

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 3, 2023
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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