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Completed

NCT Number: NCT01461590

Study of Safe Blood Transfusion Volumes to Correct Acute Severe Anaemia

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.

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Key information

Age range

60 day–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mbale Regional Referral Hospital, Mbale, Uganda

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole blood

Other

30mls/kg transfused over fours hours

Primary outcomes

  1. Correction of severe anaemia.

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Prof Kathryn Maitland

Other

Collaborators

  • Imperial College London

Registry information

Official study title

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

Acronym: Tx30

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 28, 2011
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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