Study of Safe Blood Transfusion Volumes to Correct Acute Severe Anaemia

Severe Anaemia Clinical Trial

— Tx30  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461590
• Other study ID #: KEMRI_CT_2011/0015
• Status: Completed
• Phase: Phase 2
• First received: October 26, 2011
• Last updated: March 31, 2015
• Start date: October 2011
• Est. completion date: January 2012

Study information

• Verified date: March 2015
• Source: KEMRI-Wellcome Trust Collaborative Research Program
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Council for Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Days to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Severe Anaemia

Intervention

Other:
• Whole blood
30mls/kg transfused over fours hours
• Whole blood
20mls/kg transfused over four hours

Locations

Country	Name	City	State
Uganda	Mbale Regional Referral Hospital	Mbale
Uganda	Soroti Regional Hospital	Soroti

Sponsors (2)

Lead Sponsor	Collaborator
Prof Kathryn Maitland	Imperial College London

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correction of severe anaemia.	Correction of severe anaemia to a Hb >6g/dL at 24 hours.	24 hours	Yes