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ISRCTN
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ISRCTN42496709
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ClinicalTrials.gov identifier
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Public title
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A randomised trial using Zero-Balanced Ultrafiltration in 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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N0123138588
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Study hypothesis
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To show whether a modified method of ultrafiltration, known as Zero-balance ultrafiltration (ZBUF) is effective in reducing free-radical production during cardiac surgery in adults. A reduction in free radical generation will help protect cell membranes
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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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Cardiovascular surgery
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Participants - inclusion criteria
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1. Less than 75 years of age
2. Left ventricular function less than 50%
3. Pre-operative haematocrit greater than 30%.
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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01/08/2003
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Anticipated end date
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01/06/2005
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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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Not provided at time of registration
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Interventions
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Clinical Study|Human Physiology|Inpatient Admission|Multicentre Study: National|NHS Patients|Study of Non-Therapeutic Procedure
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Primary outcome measure(s)
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To establish the effects of Zero-balanced Ultrafiltration with patients in cardiopulmonary bypass
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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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University Hospitals of Leicester NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Mr
D
Machin
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Address
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University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
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City/town
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Leicester
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Zip/Postcode
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LE1 4PW
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Country
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United Kingdom
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Tel
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+44 (0)116 258 4109
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Fax
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+44 (0)116 258 4226
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Email
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nicola.turner@uhl-tr.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 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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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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30/09/2004
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Last edited
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29/09/2009
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Date ISRCTN assigned
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30/09/2004
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