Study of Safe Blood Transfusion Volumes to Correct Acute Severe Anaemia

Phase 2

Completed

• Conditions: Severe Anaemia
• Interventions: Other: Whole blood

• Registration Number: NCT01461590
• Lead Sponsor: Prof Kathryn Maitland

Brief 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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-26
• Study First Submitted QC: 2011-10-26
• Study First Posted: 2011-10-28
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Severe anaemia(HB less than 6g/dl)at admission
• Guardian or parent willing/able to provide consent

Exclusion Criteria

• Malignancy
• Surgery
• Acute trauma
• Severe malnutrition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30ml/kg of whole blood	Whole blood	Higher volume than currently recommended
20ml/kg of whole blood transfusion	Whole blood	Standard care recommended by WHO

Primary Outcome Measures

Name	Time	Method
Correction of severe anaemia.	24 hours	Correction of severe anaemia to a Hb \>6g/dL at 24 hours.

Trial Locations

Locations (2)

Mbale Regional Referral Hospital; 🇺🇬 Mbale, Uganda

Soroti Regional Hospital; 🇺🇬 Soroti, Uganda