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Blood Transfusion

Whole Blood Transfusion for Malaria (PLATFORM Trial)

N/A
Recruiting
Led By Matthew M Ippolito, MD, PhD
Research Sponsored by Johns Hopkins Bloomberg School of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if whole blood transfusion can improve survival in children with severe malaria and low platelet count.

Who is the study for?
This trial is for children under 5 with severe malaria and low platelet count, living within a certain health clinic area. They must have a specific level of parasites in their blood and hemoglobin between certain values. Kids in foster care or planning to move out of the area can't join.
What is being tested?
The study is testing if giving whole blood transfusions to kids with severe malaria helps them survive better. It's an open-label trial, meaning everyone knows who gets the transfusion, and it randomly decides who gets treated.
What are the potential side effects?
While not specified here, whole blood transfusions may cause allergic reactions, fever, iron overload in long-term cases, lung injury from fluid overload (TACO), or infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of all-cause mortality
Secondary study objectives
Change in hemoglobin (Hb)
Change in platelet count
Change in white blood cell (WBC) count
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Whole blood transfusionExperimental Treatment1 Intervention
Whole blood transfusion x1 (20 mL/kg)
Group II: ControlActive Control1 Intervention
Standard-of-care

Find a Location

Who is running the clinical trial?

Johns Hopkins Bloomberg School of Public HealthLead Sponsor
431 Previous Clinical Trials
2,135,064 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,339 Previous Clinical Trials
14,881,499 Total Patients Enrolled
Tropical Diseases Research CentreUNKNOWN
2 Previous Clinical Trials
1,582 Total Patients Enrolled
University of California, San FranciscoOTHER
2,593 Previous Clinical Trials
14,887,818 Total Patients Enrolled
University of MarylandOTHER
169 Previous Clinical Trials
306,809 Total Patients Enrolled
Matthew M Ippolito, MD, PhDPrincipal InvestigatorJohns Hopkins University

Media Library

Whole blood transfusion (Blood Transfusion) Clinical Trial Eligibility Overview. Trial Name: NCT05711485 — N/A
Acquired Thrombocytopenia Research Study Groups: Whole blood transfusion, Control
Acquired Thrombocytopenia Clinical Trial 2023: Whole blood transfusion Highlights & Side Effects. Trial Name: NCT05711485 — N/A
Whole blood transfusion (Blood Transfusion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05711485 — N/A
~76 spots leftby Apr 2026
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