Platelet-Directed Whole Blood Transfusion Strategy for Malaria
- Conditions
- Severe MalariaThrombocytopenia
- Interventions
- Other: Whole blood transfusion
- Registration Number
- NCT05711485
- Lead Sponsor
- Johns Hopkins Bloomberg School of Public Health
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 132
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Whole blood transfusion Whole blood transfusion Whole blood transfusion x1 (20 mL/kg)
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
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
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
Parasite clearance 0-72 hours, measured every 12±2 hours Time to microscopic conversion to negative
Trial Locations
- Locations (2)
Tropical Diseases Research Centre
🇿🇲Ndola, Copperbelt, Zambia
Johns Hopkins Bloomberg School of Public Health
🇺🇸Baltimore, Maryland, United States