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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Tropical Diseases Research Centre | UNKNOWN |
| University of California, San Francisco | OTHER |
| University of Maryland |
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Open-label randomized controlled trial to test the effectiveness of whole blood transfusion for improving survival in children with severe malaria complicated by thrombocytopenia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole blood transfusion | Experimental | Whole blood transfusion x1 (20 mL/kg) |
|
| Control | No Intervention | Standard-of-care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole blood transfusion | Other | Whole blood is sourced from the Zambia National Blood Transfusion Service. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all-cause mortality | Death due to any cause | Up to hospital discharge or in-hospital death, up to 28 days on average |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin (Hb) | The difference in Hb concentration between baseline (pre-transfusion) and post-transfusion | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew M Ippolito, MD PhD | Contact | 443-287-4809 | mippolito@jhu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew M Ippolito, MD, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bloomberg School of Public Health | Not yet recruiting | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35439307 | Background | 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. |
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Data will be made available to other researchers upon reasonable request.
Approx. 1-2 years after data collection
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| ID | Term |
|---|---|
| D008288 | Malaria |
| D013921 | Thrombocytopenia |
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| D005078 | Exchange Transfusion, Whole Blood |
| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| OTHER |
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| Change in platelet count | The difference in the platelet count between baseline (pre-transfusion) and post-transfusion | 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 | 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 | 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 | Up to hospital discharge or in-hospital death, up to 28 days on average |
| Parasite clearance | Time to microscopic conversion to negative | 0-72 hours, measured every 12±2 hours |
| Tropical Diseases Research Centre | Recruiting | Ndola | Copperbelt | Zambia |
|
| D000079426 |
| Vector Borne Diseases |
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |