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

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ClinicalTrials.gov Identifier: NCT01461590
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : April 1, 2015
Sponsor:
Collaborator:
Imperial College London
Information provided by (Responsible Party):
Prof Kathryn Maitland, KEMRI-Wellcome Trust Collaborative Research Program

Study Description
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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.

Condition or disease Intervention/treatment Phase
Severe Anaemia Other: Whole blood Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Transfusion Volumes in Children With Acute Severe Anaemia
Study Start Date : October 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 20ml/kg of whole blood transfusion
Standard care recommended by WHO
 Other: Whole blood
30mls/kg transfused over fours hours

Other: Whole blood
20mls/kg transfused over four hours
Experimental: 30ml/kg of whole blood
Higher volume than currently recommended
 Other: Whole blood
30mls/kg transfused over fours hours

Other: Whole blood
20mls/kg transfused over four hours


Outcome Measures
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Primary Outcome Measures :
  1. Correction of severe anaemia. [ Time Frame: 24 hours ]
    Correction of severe anaemia to a Hb >6g/dL at 24 hours.


Eligibility Criteria
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Ages Eligible for Study:   60 Days to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461590


Locations
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Uganda
Mbale Regional Referral Hospital
Mbale, Uganda
Soroti Regional Hospital
Soroti, Uganda
Sponsors and Collaborators
Prof Kathryn Maitland
Imperial College London
Investigators
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Principal Investigator: Charles Engoru, MMed, MBChB Soroti Regional Hospital, Uganda
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof Kathryn Maitland, Professor in Infectious Diseases and Critical Care, KEMRI-Wellcome Trust Collaborative Research Program
ClinicalTrials.gov Identifier: NCT01461590    
Other Study ID Numbers: KEMRI_CT_2011/0015
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases