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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)
DOI 10.1186/ISRCTN28163533
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised trial to establish the effectiveness of graduated compression stockings (GCS) to prevent post stroke deep venous thrombosis and pulmonary embolism (PE)
Scientific title
Acronym CLOTS
Serial number at source G0200013
Study hypothesis To evaluate the role of graduated compression stockings in the prevention of post stroke DVT
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Australia, Italy, United Kingdom
Disease/condition/study domain Cardiovascular/Stroke
Participants - inclusion criteria 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
Participants - exclusion criteria 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
Anticipated start date 01/10/2003
Anticipated end date 30/09/2009
Status of trial Completed
Patient information material
Target number of participants 5500
Interventions 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
Primary outcome measure(s) 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
Secondary outcome measure(s) Not provided at time of registration
Sources of funding 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)
Trial website http://www.dcn.ed.ac.uk/clots/
Publications 1.2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19477503
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20855784
Contact name Prof  Martin  Dennis
  Address Dept. of Clinical Neurosciences
University of Edinburgh
Bramwell Dott Building
Western General Hospital
Crewe Road
  City/town Edinburgh
  Zip/Postcode EH4 2XU
  Country United Kingdom
  Tel +44 (0)131 5371082
  Fax +44 (0)131 3325150
  Email msd@skull.dcn.ed.ac.uk
Sponsor Medical Research Council (UK)
  Address 20 Park Crescent
  City/town London
  Zip/Postcode W1B 1AL
  Country United Kingdom
  Email clinical.trial@headoffice.mrc.ac.uk
Date applied 08/08/2003
Last edited 28/01/2011
Date ISRCTN assigned 11/08/2003
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