Severe MalariaPLATFORMNCT05711485
Platelet-Directed Whole Blood Transfusion Strategy for Malaria
A study testing Whole blood transfusion in people with Severe Malaria and Thrombocytopenia, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 59 months
- Conditions the study is for
- Severe Malaria, Thrombocytopenia
- What is being tested?
- Whole blood transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Feb 2024to 31 May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age <5 years
- Platelet count ≤100,000/uL
- Hemoglobin >5 and ≤11 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
- Active, not recruiting
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
Zambia1 site, 1 recruiting
- Recruiting
National Health Research and Training Institute
Ndola, Copperbelt
Jean-Bertin B. Kabuya, MD, MSPH, +260 212 620 737, jeanbertinkabuya@gmail.com
About this study
Official title: 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.
Read the detailed description
The PLATFORM trial is a multi-center, single-blinded, randomized controlled trial of whole blood transfusion for severe malaria complicated by thrombocytopenia. The trial will recruit 240 Zambian children 1 month to 5 years old with severe malaria defined according to modified WHO criteria with concomitant thrombocytopenia, defined here as a platelet count ≤100,000/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.
- Conditions
- Severe Malaria, Thrombocytopenia
- Being tested
- Whole blood transfusion
- Keywords
- Malaria, Plasmodium falciparum, Zambia
- Medical subject headings
- Malaria, Thrombocytopenia, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole blood transfusionOther
Whole blood is sourced from the Zambia National Blood Transfusion Service.
| Study group | Role | What they receive |
|---|---|---|
| Whole blood transfusion | Experimental | Whole blood transfusion x1 (20 mL/kg) Receives: Other: Whole blood transfusion |
| Control | No intervention | Standard-of-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all-cause mortality
Death due to any cause
Measured: Up to hospital discharge or in-hospital death, up to 28 days on average
Secondary outcomes (6)
Change in hemoglobin (Hb)
The difference in Hb concentration between baseline (pre-transfusion) and post-transfusion
Measured: 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
Measured: 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
The difference in the WBC count between baseline (pre-transfusion) and post-transfusion
Measured: 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
Transfusion reactions (e.g., hypersensitivity, TACO, TRALI) graded on severity and likeliness of being related to transfusion
Measured: 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
Measured: Up to hospital discharge or in-hospital death, up to 28 days on average
Parasite clearance
Time to microscopic conversion to negative
Measured: 0-72 hours, measured every 12±2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start24 Feb 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Tropical Diseases Research Centre, University of California, San Francisco, University of Maryland
- Responsible party
- Sponsor
- Investigators
- Matthew M Ippolito, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711485
- Sponsor's protocol ID
- IRB00015011
- Acronym
- PLATFORM
- Status last verified
- Sep 2026
- First submitted
- 16 Jan 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available to other researchers upon reasonable request.
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.
PubMed 35439307