NCT01461590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

3 months

First QC Date

October 26, 2011

Last Update Submit

March 31, 2015

Conditions

Severe Anaemia

Outcome Measures

Primary Outcomes (1)

  • Correction of severe anaemia.

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

    24 hours

Study Arms (2)

20ml/kg of whole blood transfusion

ACTIVE COMPARATOR

Standard care recommended by WHO

Other: Whole blood

30ml/kg of whole blood

EXPERIMENTAL

Higher volume than currently recommended

Other: Whole blood

Interventions

Whole bloodOTHER

30mls/kg transfused over fours hours

20ml/kg of whole blood transfusion30ml/kg of whole blood

Eligibility Criteria

Age60 Days - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Severe anaemia(HB less than 6g/dl)at admission
  • Guardian or parent willing/able to provide consent

You may not qualify if:

  • Malignancy
  • Surgery
  • Acute trauma
  • Severe malnutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mbale Regional Referral Hospital

Mbale, Mbale, Uganda

Location

Soroti Regional Hospital

Soroti, Soroti, Uganda

Location

Related Publications (1)

  • 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.

    PMID: 24767094DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Charles Engoru, MMed, MBChB

    Soroti Regional Hospital, Uganda

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor in Infectious Diseases and Critical Care

Study Record Dates

First Submitted

October 26, 2011

First Posted

October 28, 2011

Study Start

October 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

UG(2)