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

• Sponsor: Prof Kathryn Maitland (Other)
• Overall Status: Completed
• CT.gov ID: NCT01461590
• Collaborator: Imperial College London (Other)
• Enrollment: 160
• Locations: 2
• Arms: 2
• Duration (Months): 3
• Patients Per Site: 80
• Patients Per Site Per Month: 26.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Anaemia	Other: Whole blood; 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

• Study Type: Interventional
• 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: Oct 1, 2011
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

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

Primary Outcome Measures

1. Correction of severe anaemia. [24 hours]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Days to 12 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mbale Regional Referral Hospital	Mbale		Uganda
2	Soroti Regional Hospital	Soroti		Uganda

Sponsors and Collaborators

• Prof Kathryn Maitland
• Imperial College London

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Oct 28, 2011
• Last Update Posted: Apr 1, 2015
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Anemia

Study Results

No Results Posted as of Apr 1, 2015