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ISRCTN
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ISRCTN54081245
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ClinicalTrials.gov identifier
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Public title
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The effect of red cell washing on serum biochemistry in neonates and infants undergoing surgery for complex congenital heart disease with cardiopulmonary bypass
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0045158194
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Study hypothesis
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To determine whether pre-washing red cells affects the serum potassium and lactate levels in young children (<1 year old) who require an irradiated red cell transfusion as part of their open heart surgery.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Congenital heart disease
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Participants - inclusion criteria
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Children <1 year of age with complex congenital heart defects limited to those undergoing elective or urgent cardiac surgery with cardiopulmonary bypass.
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Participants - exclusion criteria
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Children undergoing emergency surgery as it will not be possible to pre-wash the irradiated red cells.
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Anticipated start date
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01/11/2004
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Anticipated end date
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31/01/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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40
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Interventions
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A prospective, open label study with each patient randomly assigned to a group. One group will receive unwashed irradiated red cells and the other will receive washed irradiated red cells in the cardiopulmonary bypass circuit prime.
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Primary outcome measure(s)
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Serum lactate and potassium levels.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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1. Birmingham Children's Hospital NHS Trust (UK)
2. NHS R&D Support Funding (UK)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17291775
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Contact name
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Miss
Christine
Swindell
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Address
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Birmingham Children's Hospital
Main Theatre
Steelhouse Lane
Birmingham
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City/town
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Birmingham
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Zip/Postcode
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B4 6NH
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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19/04/2011
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Date ISRCTN assigned
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30/09/2005
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