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ISRCTN
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ISRCTN28163533
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ClinicalTrials.gov identifier
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Public title
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A randomised trial to establish the effectiveness of graduated compression stockings (GCS) to prevent post stroke deep venous thrombosis and pulmonary embolism (PE)
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Scientific title
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Acronym
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CLOTS
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Serial number at source
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G0200013
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Study hypothesis
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To evaluate the role of graduated compression stockings in the prevention of post stroke DVT
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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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Australia, Italy, United Kingdom
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Disease/condition/study domain
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Cardiovascular/Stroke
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Participants - inclusion criteria
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Immobile patients with an acute stroke, in whom the responsible clinician/nurse is uncertain about either the value of graduated compression stockings (GCS) or the optimal length
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Participants - exclusion criteria
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1. Patients who, in the opinion of the responsible clinician/nurse, are unlikely to benefit from graduated compression stockings
2. Patients with subarachnoid haemorrhage
3. Patients with peripheral vascular disease, diabetic or sensory neuropathy, where the responsible clinician/nurse judges that stockings may cause tissue necrosis
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Anticipated start date
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01/10/2003
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Anticipated end date
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30/09/2009
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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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5500
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Interventions
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Trial 1: Full length GCS and routine care Or Routine care and avoid GCS
Trial 2: Full length GCS and routine care Or Below knee GCS and routine care
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Primary outcome measure(s)
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Presence of first symptomatic or asymptomatic DVT in the popliteal or femoral veins detected on either of two routine Doppler ultrasound scans (performed at about 7-10 days and 25-30 days) or contrast venography within 30 days of randomisation
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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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1. Chief Scientist Office, Scotland Ref.CZH/4/7 (UK)
2. Chest Heart and Stroke, Scotland Ref. 03/01(UK)
3. Medical Research Council Ref. G0200531(UK)
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Trial website
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http://www.dcn.ed.ac.uk/clots/
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19477503
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Contact name
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Prof
Martin
Dennis
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Address
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Dept. of Clinical Neurosciences
University of Edinburgh
Bramwell Dott Building
Western General Hospital
Crewe Road
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City/town
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Edinburgh
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Zip/Postcode
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EH4 2XU
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Country
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United Kingdom
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Tel
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+44 (0)131 5371082
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Fax
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+44 (0)131 3325150
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Email
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msd@skull.dcn.ed.ac.uk
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Sponsor
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Medical Research Council (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Date applied
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08/08/2003
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Last edited
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18/06/2009
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Date ISRCTN assigned
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11/08/2003
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