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ISRCTN
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ISRCTN27307877
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ClinicalTrials.gov identifier
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Public title
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Trisodium citrate versus heparin for locking tunnelled haemodialysis catheters: a randomised controlled trial
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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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N0158153706
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Study hypothesis
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To compare the effectiveness of 46.7% trisodium citrate versus unfractionated heparin (5000 IU/ml) in preventing clotting of tunnelled haemodialysis catheters.
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Lay summary
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Not provided at time of registration
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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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Renal failure
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Participants - inclusion criteria
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Any patient who require a new tunnelled catheter for haemodialysis. Patients fall into three groups:
1. Patients who present to the Kidney unit of the UHNS with kidney failure needing maintenance haemodialysis
2. Patients who have to switch from peritoneal to haemodialysis because of problems with their peritoneal dialysis
3. Existing haemodialysis patients who need tunnelled catheters because their arterivenous fistulas or tunnelled catheters have failed
The decision to place a tunnelled dialysis catheter is made by one of the renal consultants entirely on the basis of clinical need. Patients will be invited to take part prior to insertion of the tunnelled dialysis catheter. Randomisation will be by sealed envelopes. The only differences in dialysis care that patients will have is the locking agent, otherwise patients will have the same treatment whether they are dialysing in our main renal unit in Stoke or our two satellite units at Stafford and Leighton. They will be followed up and all dialysis related issues will be documented as per current practice.
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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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01/02/2005
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Anticipated end date
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01/08/2006
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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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Trisodium citrate versus heparin for locking tunnelled haemodialysis catheters.
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Primary outcome measure(s)
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Catheter blood flow of less than 250 ml/minute and/or venous pressure of more than 260 mmHG, persisting for one hour/session, in two consecutive sessions.
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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 Staffordshire Research and Development Consortium (UK)
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Trial website
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Publications
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Contact name
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Dr
M
Abdalla
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Address
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Nephrology Department
North Staffordshire Royal Infirmary
Princes Road
Hartshill
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City/town
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Stoke-on-Trent
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Zip/Postcode
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ST4 7LN
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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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07/09/2011
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Date ISRCTN assigned
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30/09/2005
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