Severe Malaria, Thrombocytopenia
Conditions
Keywords
Malaria, Plasmodium falciparum, Zambia
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 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.
Interventions
Whole blood is sourced from the Zambia National Blood Transfusion Service.
Sponsors
Johns Hopkins Bloomberg School of Public Health
Johns Hopkins University
Tropical Diseases Research Centre
University of California, San Francisco
University of Maryland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
* 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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States, Zambia
Contacts
CONTACTMatthew M Ippolito, MD PhD
PRINCIPAL_INVESTIGATORMatthew M Ippolito, MD, PhD
Johns Hopkins University
Outcome results
None listed