CLOTS - Clots in Legs or TEDs after Stroke

Lead Research Organisation: University of Edinburgh
Department Name: Sch of Molecular. Genetics & Pop Health

Abstract

Recent media coverage has alerted the public to the potential importance of venous thromboembolism in the context of long distance air travel, the so called economy class syndrome . Several airlines now offer passengers below knee graduated compression stockings. On this background we believe that the public will be interested in the CLOTS Trial and will be capable of understanding its results. Widespread application of the results, which will maximise the health gains, will be facilitated by a high level of public awareness. If stockings are effective we would aim to achieve a situation where patients and/or their carers would ask for stockings when in hospital. We would disseminate the trial results through the press, the Cochrane collaboration and patient and carer organisations (e.g. Stroke Association and CHSS) to ensure that we not only make healthcare professionals aware but also the general public.

Technical Summary

DVT and pulmonary embolism are major, potentially avoidable causes of morbidity and death after stroke, in other groups of immobile medical patients and after surgery. We wish to answer the following research questions.
1. Does early and routine application of full length graduated compression stockings (GCS) reduce the risk of above knee DVT after stroke?
2. Are full length GCS more effective than below knee GCS in stroke patients? This is also relevant to other immobile hospital patients.
3. Are GCS effective in preventing DVT in the non-paralysed leg in stroke patients? This is relevant to patients immobilised with other medical conditions.

CLOTS is a family of 2 multicentre, international, partially blinded, randomised controlled trials. Trial 1 will compare full length GCS with no GCS, whilst Trial 2 will compare full length and below knee GCS. Immobile patients with an acute stroke will be randomised into Trial 1 or 2. The primary outcome is DVT in the popliteal vein or more proximal vein detected on either Doppler ultrasound or venography within 30 days of randomisation. Patients will have a Doppler ultrasound of both legs between Day 7 and Day 10 and between Day 25 and Day 30. Data will be collected at hospital discharge to monitor compliance with treatment and to identify in hospital events and treatment complications. At six months surviving patients will be followed up to identify later thromboembolic events and functional status and quality of life.

The CLOTS Trial aims to evaluate an inexpensive, widely applicable intervention which has the potential to improve the outcome of many millions of patients world-wide. Although the proposed trials focus on stroke patients, its results will be relevant to the development of evidence-based treatment guidelines for patients with other acute medical conditions associated with immobility and those undergoing surgery.

Publications

10 25 50

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CLOTS (Clots In Legs Or STockings After Stroke) Trial Collaboration (2010) Thigh-length versus below-knee stockings for deep venous thrombosis prophylaxis after stroke: a randomized trial. in Annals of internal medicine

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Dennis M (2009) Venous thromboembolism after stroke: a personal view based on my interpretation of the evidence. in International journal of stroke : official journal of the International Stroke Society

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Dennis M (2009) CLOTS: an opportunity missed - Author's reply in The Lancet

 
Guideline Title Guideline 118: Management of patients with stroke: rehabilitation, prevention and management of complications, and discharge planning
Description Change in guideline (SIGN)
Geographic Reach National 
Policy Influence Type Citation in clinical guidelines
URL http://www.sign.ac.uk/guidelines/fulltext/118/index.html
 
Description Citation in Cochrane review
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in clinical reviews
URL http://www.ncbi.nlm.nih.gov/pubmed/20687069
 
Guideline Title NICE prevention of VTE
Description NICE guideline
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in clinical guidelines
Impact Widespread change in treatment - influencing perhaps 80,000 people per year in UK
 
Guideline Title SPREAD - Italian Stroke Guidelines
Description Stroke guideline (Italian)
Geographic Reach National 
Policy Influence Type Citation in clinical guidelines
 
Guideline Title Guideline 122: Prevention and management of venous thromboembolism
Description Update of SIGN guideline 122
Geographic Reach National 
Policy Influence Type Citation in clinical guidelines
URL http://www.sign.ac.uk/guidelines/fulltext/122/index.html
 
Description CSO Project Grant (Start up phase for CLOTS3 - A Multicentre Randomised Trial to Establish the Effectiveness of Intermittent Pneumatic Compression to Prevent Post Stroke Deep Vein Thrombosis)
Amount £50,000 (GBP)
Funding ID CZG/2/378 
Organisation Chief Scientist Office 
Sector Public
Country United Kingdom
Start 07/2008 
End 06/2009
 
Description CSO Project Grant (Start up phase for CLOTS3 - A Multicentre Randomised Trial to Establish the Effectiveness of Intermittent Pneumatic Compression to Prevent Post Stroke Deep Vein Thrombosis)
Amount £2,072,770 (GBP)
Funding ID CZG/2/378 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 07/2008 
End 06/2009
 
Description NIHR HTA
Amount £2,072,770 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 04/2010 
End 09/2014
 
Title CLOTS 3 Main phase trial 
Description The grant allowed us to set up the main phase of the trial which is now actively recruiting ahead of targets. 
Type Of Material Database/Collection of Data/Biological Samples 
Provided To Others? No  
Impact None yet 
 
Description Covidien 
Organisation Covidien
Country United States 
Sector Private 
PI Contribution We carried out the RCTs of their products
Collaborator Contribution Covidien have provided medical devices for us to evaluate in our trials. They also provide logistic support in distributing products to our trial centres and provide centres with training in the use of their products
Impact 19477503 20855784
 
Description UK Stroke Research network 
Organisation National Institute for Health Research
Department Stroke Research Network
Country United Kingdom 
Sector Academic/University 
PI Contribution We coordinated the trial
Collaborator Contribution They have provided support in getting trial centres set up and enroling in our trial. They fund research nurses who help with data accrual.
Impact 19477503 20855784
 
Description Conference - UK Stroke Forum, Glasgow 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact Invited lecture to present results of CLOTS trial 1 and 2

First presentation of results of CLOTS trial 2
Year(s) Of Engagement Activity 2007,2009
 
Description European Stroke Congress, Barcelona 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact 900 attended plenary sessions - some questions followed

Wider dissemination
Year(s) Of Engagement Activity 2010
 
Description European stroke conference in Stockholm 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact Presented results to conference

Wider disseminations of results
Year(s) Of Engagement Activity 2009
 
Description Incorporation of results into NICE guidelines 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? Yes
Primary Audience Health professionals
Results and Impact The NICE guidelines were changed to take account of our data

The NICE guidelines were changed to take account of our data. Other guidelines around the world are also changing
Year(s) Of Engagement Activity 2009,2010
 
Description More newspaper articles re CLOTS 2 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Primary Audience Public/other audiences
Results and Impact Articles based on results of CLOTS trials 1 and 2 appeared in Scotsman, Daily mail, Metro and daily record in UK. Also in some australian newspapers

Wide dissemination
Year(s) Of Engagement Activity 2010
 
Description News and health websites 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Primary Audience Public/other audiences
Results and Impact Information about the trial results appeared on websites from around the world

Wider dissemination to lay audiences
Year(s) Of Engagement Activity 2010
 
Description Newspaper articles 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Primary Audience Public/other audiences
Results and Impact Results appeared in multiple newspapers including: New York Times, Washington Post, Times, Telegraph, Scotsman, Daily Mail

Wider dissemination
Year(s) Of Engagement Activity 2009
 
Description Poster presentations 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact We have presented posters to advetise the trial at many meetings. Some of these include preliminary analyses. The audiences are stroke physicians, nurses.

Improved recruitment
Year(s) Of Engagement Activity 2006,2007,2008,2009
 
Description Presentation of results in Preston 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact Lots of questions from a manily consultant audience from region

Participation of some centres in our ongoing trial
Year(s) Of Engagement Activity 2010
 
Description Presentations to Stroke research networks 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Primary Audience Health professionals
Results and Impact Presented results in Scotland and England

wider dissemination
Year(s) Of Engagement Activity 2009,2010
 
Description Public understanding of science, Glasgow 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Primary Audience Public/other audiences
Results and Impact Presented the trial to the public i Glasgow at event run by Chief scientist office

Wider dissemination
Year(s) Of Engagement Activity 2007
 
Description Radio interview - BBC Scotland drive 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Primary Audience Public/other audiences
Results and Impact Interviewed about the results

Wider dissemination
Year(s) Of Engagement Activity 2009
 
Description U.S. Radio - podcast - Clinical conversations 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Primary Audience Public/other audiences
Results and Impact Podcast to be downloaded by public

Wider dissemination
Year(s) Of Engagement Activity 2009,2010
 
Description Webcast of results 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Primary Audience Public/other audiences
Results and Impact We have prepared webcasts giving results of the trial. These can be streamed from our website.

Wider dissemination
Year(s) Of Engagement Activity 2009