A randomised trial to establish the effectiveness of graduated compression stockings (GCS) to prevent post stroke deep venous thrombosis and pulmonary embolism (PE)

ISRCTN	ISRCTN28163533
DOI	https://doi.org/10.1186/ISRCTN28163533
Secondary identifying numbers	G0200013

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Martin Dennis
Scientific

Dept. of Clinical Neurosciences
University of Edinburgh
Bramwell Dott Building
Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
United Kingdom

Phone	+44 (0)131 5371082
Email	msd@skull.dcn.ed.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study acronym	CLOTS
Study objectives	To evaluate the role of graduated compression stockings in the prevention of post stroke DVT
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cardiovascular/Stroke
Intervention	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
Intervention type	Other
Primary outcome measure	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 measures	Not provided at time of registration
Overall study start date	01/10/2003
Completion date	30/09/2009

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	5500
Key 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
Key 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
Date of first enrolment	01/10/2003
Date of final enrolment	30/09/2009

Dept. of Clinical Neurosciences

Edinburgh
EH4 2XU
United Kingdom

Medical Research Council (UK)
Government

20 Park Crescent
London
W1B 1AL
United Kingdom

Email	clinical.trial@headoffice.mrc.ac.uk

Government

Chief Scientist Office, Scotland Ref.CZH/4/7 (UK)

No information available

Chest Heart and Stroke, Scotland Ref. 03/01(UK)

No information available

Medical Research Council Ref. G0200531(UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	1. results	06/06/2009		Yes	No
Results article	results	02/11/2010		Yes	No