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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by KEMRI-Wellcome Trust Collaborative Research Program.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Imperial College London
Information provided by (Responsible Party):
Prof Kathryn Maitland, KEMRI Wellcome Trust Research Programme
ClinicalTrials.gov Identifier:
NCT01461590
First received: October 26, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
  Purpose

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 Intervention Phase
Severe Anaemia
Other: Whole blood
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Transfusion Volumes in Children With Acute Severe Anaemia

Resource links provided by NLM:


Further study details as provided by KEMRI-Wellcome Trust Collaborative Research Program:

Primary Outcome Measures:
  • Correction of severe anaemia. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Correction of severe anaemia to a Hb >6g/dL at 24 hours.


Estimated Enrollment: 160
Study Start Date: October 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 20ml/kg of whole blood Other: Whole blood
20mls/kg transfused over four hours
Experimental: 30ml/kg of whole blood Other: Whole blood
30mls/kg transfused over fours hours

  Eligibility

Ages Eligible for Study:   60 Days to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461590

Contacts
Contact: Mukami J. Mbogo, MPH, BSN +254 715 461761 Mmbogo@kilifi.kemri-wellcome.org
Contact: Prof Kathryn Maitland, PhD, MD +254 41 7522063 kathryn.maitland@gmail.com

Locations
Uganda
Mbale Regional Referral Hospital Recruiting
Mbale, Uganda
Contact: Peter O Olupot, MPH, MBChB    +256772457217    polupotolupot@yahoo.com   
Contact: Paul Ongodia, RN    +256774121190    paulongodia@gmail.com   
Principal Investigator: Dr. Peter O Olupot, MPH, MBChB         
Soroti Regional Hospital Recruiting
Soroti, Uganda
Contact: Charles Engoru, MMEd, MBChB    +256772458587    charlesengoru@yahoo.co.uk   
Contact: Denis Amorut, RN    +256774573911    damoruts@gmail.com   
Principal Investigator: Dr. Charles Engoru, MMed, MBChB         
Sponsors and Collaborators
Prof Kathryn Maitland
Imperial College London
Investigators
Principal Investigator: Charles Engoru, MMed, MBChB Soroti Regional Hospital, Uganda
  More Information

No publications provided by KEMRI-Wellcome Trust Collaborative Research Program

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof Kathryn Maitland, Professor in Infectious Diseases and Critical Care, KEMRI Wellcome Trust Research Programme
ClinicalTrials.gov Identifier: NCT01461590     History of Changes
Other Study ID Numbers: KEMRI_CT_2011/0015
Study First Received: October 26, 2011
Last Updated: October 26, 2011
Health Authority: Uganda: National Council for Science and Technology

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on July 22, 2014