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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01461590
Acronym
Tx30
Enrollment
160
Registered
2011-10-28
Start date
2011-10-31
Completion date
2012-01-31
Last updated
2015-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Anaemia

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.

Interventions

30mls/kg transfused over fours hours

Sponsors

Imperial College London
CollaboratorOTHER
Prof Kathryn Maitland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Days to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correction of severe anaemia.24 hoursCorrection of severe anaemia to a Hb \>6g/dL at 24 hours.

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026