NCT01461590

Study of Safe Blood Transfusion Volumes to Correct Acute Severe Anaemia

Phase II Trial of Transfusion Volumes in Children With Acute Severe Anaemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Prof Kathryn Maitland · Academic / Other
• Sex: All
• Age: 60 Days – 12 Years
• Healthy volunteers: Not accepted

Summary

Greater volume of whole blood(30mls/kg compared to 20mls/kg) following standard calculations, given to children with severe anaemia will be beneficial in haematological correction and can be given safely since respiratory distress and haemodynamic changes result from acidosis and compensation in these children rather than from biventricular failure.

Detailed description

Severe anemia (SA, hemoglobin \<6 g/dl) is a leading cause of pediatric hospital admission in Africa, with significant in-hospital mortality. The underlying etiology is often infectious, but specific pathogens are rarely identified. Guidelines developed to encourage rational blood use recommend a standard volume of whole blood (20 ml/kg) for transfusion, but this is commonly associated with a frequent need for repeat transfusion and poor outcome. Evidence is lacking on what haemoglobin threshold criteria for intervention and volume are associated with the optimal survival outcomes. We evaluated the safety and efficacy of a higher volume of whole blood (30 ml/kg; Tx30: n = 78) against the standard volume (20 ml/kg; Tx20: n = 82) in Ugandan children (median age 35.5 months (interquartile range (IQR) 12.5 to 52.5)) for 24-hour anemia correction (hemoglobin \>6 g/dl: primary outcome) and 28-day survival.

Conditions

• Severe Anaemia

Interventions

Type	Name	Description
OTHER	Whole blood	30mls/kg transfused over fours hours
OTHER	Whole blood	20mls/kg transfused over four hours

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-10-28
• Last updated: 2015-04-01

Locations

2 sites across 1 country: Uganda