About this trial

Open-label randomized controlled trial to test the effectiveness of whole blood transfusion for improving survival in children with severe malaria complicated by thrombocytopenia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age <5 years

Platelet count ≤100,000/uL

Hemoglobin >5 and ≤11 g/dL

P. falciparum parasitemia ≥500 parasites/uL

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

132 Participants

are divided into 2 treatment groups

Group A: Whole blood transfusionExperimental treatment 1 intervention

Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incidence of all-cause mortality

Death due to any cause

Time frame

Up to hospital discharge or in-hospital death, up to 28 days on average

Secondary outcomes

1

Change in hemoglobin (Hb)

The difference in Hb concentration between baseline (pre-transfusion) and post-transfusion

Time frame

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

2

Change in platelet count

The difference in the platelet count between baseline (pre-transfusion) and post-transfusion

Time frame

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

3

Change in white blood cell (WBC) count

The difference in the WBC count between baseline (pre-transfusion) and post-transfusion

Time frame

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

4

Incidence of transfusion reaction

Transfusion reactions (e.g., hypersensitivity, TACO, TRALI) graded on severity and likeliness of being related to transfusion

Time frame

During or after transfusion, up to the day of hospital discharge or in-hospital death, up to 28 days on average

Platelet-Directed Whole Blood Transfusion Strategy for Malaria

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts