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

March 31, 2015 updated by: Prof Kathryn Maitland

Phase II Trial of Transfusion Volumes in Children With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Mbale, Uganda
        • Mbale Regional Referral Hospital
      • Soroti, Uganda
        • Soroti Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correction of severe anaemia.
Time Frame: 24 hours
Correction of severe anaemia to a Hb >6g/dL at 24 hours.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof Kathryn Maitland

Collaborators

Imperial College London

Investigators

  • Principal Investigator: Charles Engoru, MMed, MBChB, Soroti Regional Hospital, Uganda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

October 26, 2011

First Submitted That Met QC Criteria

October 26, 2011

First Posted (Estimate)

October 28, 2011

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEMRI_CT_2011/0015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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