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 weeks3 visits

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

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.