Platelet-Directed Whole Blood Transfusion Strategy for Malaria

Thrombocytopenia Clinical Trial

— PLATFORM  

Official title:

Clinical and Translational Investigations of Severe Malaria Pathophysiology [Parent Study Protocol]

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05711485
• Other study ID #: 15011
• Secondary ID: IRB00015011
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Matthew M Ippolito, MD PhD
• Phone: 443-287-4809
• Email: mippolito[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: February 28, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• 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

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

Related Conditions & MeSH terms

• Malaria
• Severe Malaria
• Thrombocytopenia

Intervention

Other:
• Whole blood transfusion
Whole blood is sourced from the Zambia National Blood Transfusion Service.

Locations

Country	Name	City	State
United States	Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland
Zambia	Tropical Diseases Research Centre	Ndola	Copperbelt

Sponsors (5)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Johns Hopkins University, Tropical Diseases Research Centre, University of California, San Francisco, University of Maryland

Countries where clinical trial is conducted

United States,  Zambia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all-cause mortality	Death due to any cause	Up to hospital discharge or in-hospital death, up to 28 days on average
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Parasite clearance	Time to microscopic conversion to negative	0-72 hours, measured every 12±2 hours