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ISRCTN
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ISRCTN42608249
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ClinicalTrials.gov identifier
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Public title
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The Effect of Coating of the Cardiopulmonary Bypass Circuit with Poly-2-methoxyethylacrylate (PMEA) on the Systemic Inflammatory Response
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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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N0295142271
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Study hypothesis
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To compare outcomes in patients undergoing coronary artery bypass grafting using either standard non-coated cardiopulmonary circuits or circuits in which all components have been coated with PMEA.
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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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Surgery: Cardiopulmonary bypass
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Participants - inclusion criteria
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Patients undergoing first-time, isolated, elective coronary artery bypass grafting at UHCW, who have not taken any anti-platelet medication for five days previous to the operation, will be eligible for the study. We aim to recruit 40 patients.
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Participants - exclusion criteria
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1. Patients undergoing repeated surgery
2. Patients undergoing emergency surgery
3. Patients taking antiplatelet medication
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Anticipated start date
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19/04/2004
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Anticipated end date
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30/10/2004
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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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Prospective randomised controlled trial.
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Primary outcome measure(s)
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Post-operative blood loss and transfusion requirements, pulmonary, renal, neurological, cardiac and infective complications during hospitalisation, duration of ICU and hospital stay and thirty day mortality. The magnitude of the inflammatory response will be assessed by measuring plasma levels of inflammatory mediators. Platelet function and coagulation will be assessed by flow cytometry and thromboelastography.
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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 Coventry and Warwickshire NHS Trust (UK)
NHS R&D Support Funding (UK)
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Trial website
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Publications
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Contact name
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Mr
Moninder
Bhabra
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Address
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Cardiothoracic Unit, 3rd floor
UHCW NHS Trust
Clifford Bridge Road
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City/town
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Coventry
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Zip/Postcode
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CV2 2DX
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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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10/07/2009
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Date ISRCTN assigned
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30/09/2005
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