Study of Safe Blood Transfusion Volumes to Correct Acute Severe Anaemia

NCT ID: NCT01461590

Last Updated: 2015-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-01-31

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.

Conditions

Severe Anaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

20ml/kg of whole blood transfusion

Standard care recommended by WHO

Group Type: ACTIVE_COMPARATOR

Whole blood

Intervention Type: OTHER

30mls/kg transfused over fours hours

Whole blood

Intervention Type: OTHER

20mls/kg transfused over four hours

30ml/kg of whole blood

Higher volume than currently recommended

Group Type: EXPERIMENTAL

Whole blood

Intervention Type: OTHER

30mls/kg transfused over fours hours

Whole blood

Intervention Type: OTHER

20mls/kg transfused over four hours

Interventions

Whole blood

30mls/kg transfused over fours hours

Intervention Type: OTHER

Whole blood

20mls/kg transfused over four hours

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Days
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: collaborator

Prof Kathryn Maitland

OTHER

Sponsor Role: lead

Responsible Party

Prof Kathryn Maitland

Professor in Infectious Diseases and Critical Care

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Charles Engoru, MMed, MBChB

Role: PRINCIPAL_INVESTIGATOR

Soroti Regional Hospital, Uganda

Locations

Mbale Regional Referral Hospital

Mbale, Mbale, Uganda

Soroti Regional Hospital

Soroti, Soroti, Uganda

Countries

Uganda

References

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.

Reference Type: DERIVED

PMID: 24767094 (View on PubMed)

Other Identifiers

KEMRI_CT_2011/0015

Identifier Type: -

Identifier Source: org_study_id