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

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 |
- Correction of severe anaemia. [ Time Frame: 24 hours ]Correction of severe anaemia to a Hb >6g/dL at 24 hours.

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Ages Eligible for Study: | 60 Days to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts 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

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
Uganda | |
Mbale Regional Referral Hospital | |
Mbale, Uganda | |
Soroti Regional Hospital | |
Soroti, Uganda |
Principal Investigator: | Charles Engoru, MMed, MBChB | Soroti Regional Hospital, Uganda |
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 |
Anemia Hematologic Diseases |