Platelet-Directed Whole Blood Transfusion Strategy for Malaria

Johns Hopkins Bloomberg School of Public Health132 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

132

Conditions

Severe Malaria Thrombocytopenia

Interventions

Whole blood transfusionOTHER

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

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 59 Months

Medical Language ↔ Plain English

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

Locations (2)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

NOT_YET_RECRUITING

Tropical Diseases Research Centre

Ndola, Copperbelt, Zambia

RECRUITING

Outcomes

Primary Outcomes

Incidence of all-cause mortality

Death due to any cause

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

Secondary Outcomes

Change in hemoglobin (Hb)

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

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

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

Change in white blood cell (WBC) count

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

Incidence of transfusion reaction

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

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

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

Central Contacts

Matthew M Ippolito, MD PhD

CONTACT

443-287-4809 mippolito@jhu.edu

Data from ClinicalTrials.gov

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