Platelet-Directed Whole Blood Transfusion Strategy for Malaria

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins Bloomberg School of Public Health
Study ID
NCT05711485
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Months - 59 Months
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Feb 24, 2024
Status verified
Oct 2025
Primary completion
Apr 30, 2027
Completion
May 31, 2028

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Whole blood transfusion
    Whole blood transfusion x1 (20 mL/kg)
  • No Intervention: Control
    Standard-of-care

Primary Outcome Measure

Incidence of all-cause mortality [ Time Frame: Up to hospital discharge or in-hospital death, up to 28 days on average ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Bloomberg School of Public HealthBaltimoreMaryland21205
Matthew Ippolito, MD, PhD
[email protected]
443-287-4809

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By research site
Johns Hopkins Bloomberg School of Public Health· Baltimore, MD

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