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

Primary Purpose

Severe Malaria, Thrombocytopenia

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Whole blood transfusion
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Severe Malaria focused on measuring Malaria, Plasmodium falciparum, Zambia

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Bloomberg School of Public Health
  • Tropical Diseases Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Whole blood transfusion

Control

Arm Description

Whole blood transfusion x1 (20 mL/kg)

Standard-of-care

Outcomes

Primary Outcome Measures

Incidence of all-cause mortality
Death due to any cause

Secondary Outcome Measures

Change in hemoglobin (Hb)
The difference in Hb concentration between baseline (pre-transfusion) and post-transfusion
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
Length of hospitalization
Interval in days from date of admission to date of discharge/death
Parasite clearance
Time to microscopic conversion to negative

Full Information

First Posted
January 16, 2023
Last Updated
August 18, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Johns Hopkins University, Tropical Diseases Research Centre, University of California, San Francisco, University of Maryland
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1. Study Identification

Unique Protocol Identification Number
NCT05711485
Brief Title
Platelet-Directed Whole Blood Transfusion Strategy for Malaria
Acronym
PLATFORM
Official Title
Clinical and Translational Investigations of Severe Malaria Pathophysiology [Parent Study Protocol]
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Johns Hopkins University, Tropical Diseases Research Centre, University of California, San Francisco, University of Maryland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Malaria, Thrombocytopenia
Keywords
Malaria, Plasmodium falciparum, Zambia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Whole blood transfusion
Arm Type
Experimental
Arm Description
Whole blood transfusion x1 (20 mL/kg)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard-of-care
Intervention Type
Other
Intervention Name(s)
Whole blood transfusion
Intervention Description
Whole blood is sourced from the Zambia National Blood Transfusion Service.
Primary Outcome Measure Information:
Title
Incidence of all-cause mortality
Description
Death due to any cause
Time Frame
Up to hospital discharge or in-hospital death, up to 28 days on average
Secondary Outcome Measure Information:
Title
Change in hemoglobin (Hb)
Description
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
Title
Change in platelet count
Description
The difference in the platelet count 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
Title
Change in white blood cell (WBC) count
Description
The difference in the WBC count 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
Title
Incidence of transfusion reaction
Description
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
Title
Length of hospitalization
Description
Interval in days from date of admission to date of discharge/death
Time Frame
Up to hospital discharge or in-hospital death, up to 28 days on average
Title
Parasite clearance
Description
Time to microscopic conversion to negative
Time Frame
0-72 hours, measured every 12±2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Johns Hopkins Bloomberg School of Public Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Tropical Diseases Research Centre
City
Ndola
State/Province
Copperbelt
Country
Zambia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available to other researchers upon reasonable request.
IPD Sharing Time Frame
Approx. 1-2 years after data collection
Citations:
PubMed Identifier
35439307
Citation
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.
Results Reference
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Platelet-Directed Whole Blood Transfusion Strategy for Malaria

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