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

Primary Purpose

Severe Anaemia

Status
Completed
Phase
Phase 2
Locations
Uganda
Study Type
Interventional
Intervention
Whole blood
Whole blood
Sponsored by
Prof Kathryn Maitland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Anaemia

Eligibility Criteria

60 Days - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Mbale Regional Referral Hospital
  • Soroti Regional Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

20ml/kg of whole blood transfusion

30ml/kg of whole blood

Arm Description

Standard care recommended by WHO

Higher volume than currently recommended

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 26, 2011
Last Updated
March 31, 2015
Sponsor
Prof Kathryn Maitland
Collaborators
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT01461590
Brief Title
Study of Safe Blood Transfusion Volumes to Correct Acute Severe Anaemia
Acronym
Tx30
Official Title
Phase II Trial of Transfusion Volumes in Children With Acute Severe Anaemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof Kathryn Maitland
Collaborators
Imperial College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Anaemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20ml/kg of whole blood transfusion
Arm Type
Active Comparator
Arm Description
Standard care recommended by WHO
Arm Title
30ml/kg of whole blood
Arm Type
Experimental
Arm Description
Higher volume than currently recommended
Intervention Type
Other
Intervention Name(s)
Whole blood
Intervention Description
30mls/kg transfused over fours hours
Intervention Type
Other
Intervention Name(s)
Whole blood
Intervention Description
20mls/kg transfused over four hours
Primary Outcome Measure Information:
Title
Correction of severe anaemia.
Description
Correction of severe anaemia to a Hb >6g/dL at 24 hours.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Days
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Engoru, MMed, MBChB
Organizational Affiliation
Soroti Regional Hospital, Uganda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mbale Regional Referral Hospital
City
Mbale
Country
Uganda
Facility Name
Soroti Regional Hospital
City
Soroti
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
24767094
Citation
Olupot-Olupot P, Engoru C, Thompson J, Nteziyaremye J, Chebet M, Ssenyondo T, Dambisya CM, Okuuny V, Wokulira R, Amorut D, Ongodia P, Mpoya A, Williams TN, Uyoga S, Macharia A, Gibb DM, Walker AS, Maitland K. Phase II trial of standard versus increased transfusion volume in Ugandan children with acute severe anemia. BMC Med. 2014 Apr 25;12:67. doi: 10.1186/1741-7015-12-67.
Results Reference
derived

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Study of Safe Blood Transfusion Volumes to Correct Acute Severe Anaemia

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