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ISRCTN
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ISRCTN43363116
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ClinicalTrials.gov identifier
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Public title
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Effects of tranexamic acid in total knee arthroplasty - pilot study
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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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N0162147151
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Study hypothesis
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To establish whether tranexamic acid can reduce bleeding after knee replacement surgery without increasing the risk of deep venous thrombosis.
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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: Total knee arthroplasty
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Participants - inclusion criteria
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15 patients, 15 control patients of any age who are planned to have total knee arthroplasty
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/11/2000
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Anticipated end date
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31/05/2004
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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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30
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Interventions
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Prospective, randomised controlled trial of 15 mg/ kg tranexamic acid v equivalent volume of normal saline given iv prior to tourniquet release during TKA
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Primary outcome measure(s)
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1. Blood loss in the first 48 hours post op
2. Transfusion requirements
3. Screen-detected DVT
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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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Northampton General Hospital NHS Trust (UK), R&D NHS support funding
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Trial website
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16487712
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Contact name
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Mr
Christopher
Little
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Address
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Dept Orthopaedics
Northampton General Hospital NHS Trust
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City/town
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Northampton
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Zip/Postcode
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NN1 5BD
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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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21/04/2011
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Date ISRCTN assigned
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30/09/2005
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