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ISRCTN
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ISRCTN10862406
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ClinicalTrials.gov identifier
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Public title
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Fibrin sealant to reduce blood loss after hip replacement
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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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N0234117607
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Study hypothesis
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Does fibrin sealant reduce blood loss after primary and revision hip replacement?
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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: Hip replacement
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Participants - inclusion criteria
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Primary hip replacement: 60 patients not on anticoagulant medications, without blood autoantibodies and with pre-operation Hb level >12.5 will be randomised into treatment and control groups.
Revision Hip Replacement: 30 consecutive patients in treatment group not randomized. Control group will be historical, with information regarding blood loss gained from a retrospective review of notes.
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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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01/08/2002
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Anticipated end date
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31/07/2003
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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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90
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Interventions
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Two groups: Revision total hip replacement and Primary total hip replacement.
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Primary outcome measure(s)
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Quantitative estimate of per-operative blood loss, measurement of post-operative blood loss volume via drains, post-operative haemaglobin level, number of patients requiring blood transfusion.
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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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North Bristol 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
DKA
Smart
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Address
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Department of Orthopaedics (AOC)
North Bristol NHS Trust
Southmead Hospital
Westbury-on-Trym
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City/town
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Bristol
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Zip/Postcode
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BS10 5NB
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Country
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United Kingdom
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - 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.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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13/05/2009
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Date ISRCTN assigned
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12/09/2003
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