Condition category
Circulatory System
Date applied
08/08/2003
Date assigned
11/08/2003
Last edited
28/01/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.dcn.ed.ac.uk/clots/

Contact information

Type

Scientific

Primary contact

Prof Martin Dennis

ORCID ID

Contact details

Dept. of Clinical Neurosciences
University of Edinburgh
Bramwell Dott Building
Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
United Kingdom
+44 (0)131 5371082
msd@skull.dcn.ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0200013

Study information

Scientific title

Acronym

CLOTS

Study hypothesis

To evaluate the role of graduated compression stockings in the prevention of post stroke DVT

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/2003

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

5500

Participant 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

Recruitment start date

01/10/2003

Recruitment end date

30/09/2009

Locations

Countries of recruitment

Australia, Italy, United Kingdom

Trial participating centre

Dept. of Clinical Neurosciences
Edinburgh
EH4 2XU
United Kingdom

Sponsor information

Organisation

Medical Research Council (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medical Research Council Ref. G0200531(UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1.2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19477503
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20855784

Publication citations

  1. Results

    Thigh-length versus below-knee stockings for deep venous thrombosis prophylaxis after stroke: a randomized trial., Ann. Intern. Med., 2010, 153, 9, 553-562, doi: 10.7326/0003-4819-153-9-201011020-00280.

  2. , Dennis M, Sandercock PA, Reid J, Graham C, Murray G, Venables G, Rudd A, Bowler G, Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): a multicentre, randomised controlled trial., Lancet, 2009, 373, 9679, 1958-1965, doi: 10.1016/S0140-6736(09)60941-7.

Additional files

Editorial Notes