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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Translational Investigations of Severe Malaria Pathophysiology [Parent Study Protocol]
- ClinicalTrials.gov ID
- NCT05711485
- Acronym / sponsor ID
- PLATFORM / IRB00015011
- Conditions
- Severe Malaria, Thrombocytopenia
- Keywords
- Malaria, Plasmodium falciparum, Zambia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Tropical Diseases Research Centre, University of California, San Francisco, University of Maryland
- Study start
- 24 Feb 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole blood transfusion | Experimental | Other: Whole blood transfusionWhole blood transfusion x1 (20 mL/kg) |
| Control | No intervention | –Standard-of-care |
Who may qualify
- Ages
- 1 month to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole blood transfusionWhole blood is sourced from the Zambia National Blood Transfusion Service. | Other | Whole blood transfusion |
Primary outcome
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
6 secondary outcomes
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
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
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
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
Length of hospitalization
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 35439307Ippolito 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.
- Individual participant dataSharing planned: Yes. Data will be made available to other researchers upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew M Ippolito, MD, PhD principal investigator
Johns Hopkins University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew M Ippolito, MD PhD (443-287-4809, mippolito@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all-cause mortality (time frame: Up to hospital discharge or in-hospital death, up to 28 days on average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05711485, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.