Platelet-Directed Whole Blood Transfusion Strategy for Malaria (PLATFORM)

March 18, 2024 updated by: Johns Hopkins Bloomberg School of Public Health

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Matthew M Ippolito, MD PhD
  • Phone Number: 443-287-4809
  • Email: mippolito@jhu.edu

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Not yet recruiting
        • Johns Hopkins Bloomberg School of Public Health
        • Contact:
  • Zambia
    • Copperbelt
      • Ndola, Copperbelt, Zambia
        • Recruiting
        • Tropical Diseases Research Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole blood transfusion
Whole blood transfusion x1 (20 mL/kg)
Other: Whole blood transfusion
Whole blood is sourced from the Zambia National Blood Transfusion Service.
No Intervention: Control
Standard-of-care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to hospital discharge or in-hospital death, up to 28 days on average

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
The difference in the platelet count between baseline (pre-transfusion) and post-transfusion
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
The difference in the WBC count between baseline (pre-transfusion) and post-transfusion
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
Transfusion reactions (e.g., hypersensitivity, TACO, TRALI) graded on severity and likeliness of being related to transfusion
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
Interval in days from date of admission to date of discharge/death
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
Time to microscopic conversion to negative
0-72 hours, measured every 12±2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2024

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

February 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15011
  • IRB00015011 (Other Identifier: JHSPH IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be made available to other researchers upon reasonable request.

IPD Sharing Time Frame

Approx. 1-2 years after data collection

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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