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Study of Safe Blood Transfusion Volumes to Correct Acute Severe Anaemia (Tx30)

P

Prof Kathryn Maitland

Status and phase

Completed
Phase 2

Conditions

Severe Anaemia

Treatments

Other: Whole blood

Study type

Interventional

Funder types

Other

Identifiers

NCT01461590
KEMRI_CT_2011/0015

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 patients

Sex

All

Ages

60 days to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

20ml/kg of whole blood transfusion
Active Comparator group
Description:
Standard care recommended by WHO
Treatment:
Other: Whole blood
Other: Whole blood
30ml/kg of whole blood
Experimental group
Description:
Higher volume than currently recommended
Treatment:
Other: Whole blood
Other: Whole blood

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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