PLATFORM: Platelet-Directed Whole Blood Transfusion Strategy for Malaria
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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 |
Outcome Measures
Primary Outcome Measures
- Incidence of all-cause mortality [Up to hospital discharge or in-hospital death, up to 28 days on average]
Death due to any cause
Secondary Outcome Measures
- Change in hemoglobin (Hb) [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
- Change in platelet count [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
- Change in white blood cell (WBC) count [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
- Incidence of transfusion reaction [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
- Length of hospitalization [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
- Parasite clearance [0-72 hours, measured every 12±2 hours]
Time to microscopic conversion to negative
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age <5 years
-
Platelet count ≤75,000/uL
-
Hemoglobin >5 and ≤9 g/dL
-
- 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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins Bloomberg School of Public Health | Baltimore | Maryland | United States | 21205 |
| 2 | Tropical Diseases Research Centre | Ndola | Copperbelt | Zambia |
Sponsors and Collaborators
- Johns Hopkins Bloomberg School of Public Health
- Johns Hopkins University
- Tropical Diseases Research Centre
- University of California, San Francisco
- University of Maryland
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 15011