Menu
Recruiting NCT05711485

Platelet-Directed Whole Blood Transfusion Strategy for Malaria

No phase Interventional Severe Malaria Thrombocytopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Whole blood transfusion.
Who it may be relevant to
Registry conditions: Severe Malaria, Thrombocytopenia. Basic parameters: 6 months — 59 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Zambia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Incidence of all-cause mortality [Time frame: Up to hospital discharge or in-hospital death, up to 28 days on average]
Secondary outcome measures (6)
  • 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]
  • 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]
  • 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]
  • 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]
  • Length of hospitalization [Time frame: Up to hospital discharge or in-hospital death, up to 28 days on average]
  • Parasite clearance [Time frame: 0-72 hours, measured every 12±2 hours]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Johns Hopkins Bloomberg School of Public Health — Baltimore
Zambia · 1 center
  • Tropical Diseases Research Centre — Ndola

Publications

  • Ippolito MM, Kabuya JB, Hauser M, Kamavu LK, Banda PM, Yanek LR, Malik R, Mulenga M, Bailey JA, Chongwe G, Louis TA, Shapiro TA, Moss WJ; Southern and Central Africa International Centers of Excellence for Malaria Research. Whole Blood Transfusion for Severe Malarial Anemia in a High Plasmodium falciparum Transmission Setting. Clin Infect Dis. 2022 Nov 30;75(11):1893-1902. doi: 10.1093/cid/ciac304 PMID 35439307

Identifiers

NCT: NCT05711485 · IRB00015011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗