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| [ ...Back to search results ] | [ Print-friendly version ] |
| A randomised trial to establish the effectiveness of intermittent pneumatic compression sleeves (applied to the legs) to prevent post stroke deep vein thrombosis (DVT) |
| ISRCTN | ISRCTN93529999 |
| ClinicalTrials.gov identifier | NCT00789542 |
| Public title | A randomised trial to establish the effectiveness of intermittent pneumatic compression sleeves (applied to the legs) to prevent post stroke deep vein thrombosis (DVT) |
| Scientific title | A randomised trial to establish the effectiveness of intermittent pneumatic compression to prevent post stroke deep vein thrombosis (DVT) |
| Acronym | CLOTS-3 |
| Serial number at source | HTA 08/14/03; Version 2 |
| Study hypothesis |
Does early and routine application of intermittent pneumatic compression (IPC) in addition to routine care reduce the risk of above knee deep vein thrombosis (DVT) in the weeks following an acute stroke?
More details can be found at http://www.hta.ac.uk/2231 Protocol at http://www.hta.ac.uk/protocols/200800140003.pdf Please note that as of 20/05/10 this record has been updated to reflect changes in the trial protocol from Version 1 to Version 2. Point 3 of the original exclusion criteria has been removed, this and all updates can be found in the relevant field under the above update date. Please also note that this trial has been extended. The anticipated end date has been changed from 30/04/13 to 30/09/14. |
| Lay summary | |
| Ethics approval |
Added 20/05/10:
1. MREC Scotland approved on the 25th of September 2008 (ref: 08/MRE00/73) 2. Additional approval for England and Wales obtained on the 26th of August 2008 (ref: 08/H0906/137) |
| Study design | Multi-centre randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Stroke |
| Participants - inclusion criteria |
1. Patients (both males and females) who were admitted to hospital within 3 days of a clinical stroke fulfilling the World Health Organization (WHO) criteria
2. Those who are not able to get up from a chair/ out of bed and walk to the toilet without the help of another person |
| Participants - exclusion criteria |
Current information as of 20/05/10:
1. Patients with stroke due to subarachnoid haemorrhage 2. Patients who, in the opinion of the responsible clinician/nurse, are unlikely to benefit from IPC 3. Patients with contraindications for the use of IPC 4. Patients who already have swelling or other signs of an existing DVT. Such patients may be recruited once a DVT has been excluded by normal D Dimers or Compression Doppler ultrasound. 5. Patients under 16 year of age Initial information at time of registration: 1. Patients with stroke due to subarachnoid haemorrhage 2. Patients who, in the opinion of the responsible clinician/nurse, are unlikely to benefit from IPC 3. Patients who are anticoagulated (taking warfarin, unfractionated heparin, low molecular weight heparin or direct thrombin inhibitors) at the time of enrolment in whom it is planned to continue the anticoagulation throughout the first week or two after the stroke 4. Patients with contraindications for the use of IPC 5. Patients who already have swelling or other signs of an existing DVT. Such patients may be recruited once a DVT has been excluded by normal D Dimers or Compression Doppler ultrasound. 6. Patients under 16 year of age |
| Anticipated start date | 01/01/2009 |
| Anticipated end date | 30/09/2014 |
| Status of trial | Ongoing |
| Patient information material | Information for patients may be found at http://www.dcn.ed.ac.uk/clots/clots_patient_area/index.html |
| Target number of participants | 2,000 |
| Interventions |
Routine care vs routine care plus IPC sleeves. If allocated to the intervention group, thigh length IPC sleevs should be applied to both legs for 30 days.
Details of Joint Sponsor: Lothian NHS Board Deaconess House 148 Pleasance Edinburgh EH8 9RS United Kingdom http://www.nhslothian.scot.nhs.uk |
| Primary outcome measure(s) | Presence of definite or probable symptomatic or asymptomatic DVT in the popliteal or femoral veins detected on a screening Compression Doppler ultrasound scan or any symptomatic DVT in the popliteal or femoral veins confirmed on Compression Doppler ultrasound, contrast venography or magnetic resonance imaging (MRI) direct thrombus imaging within 30 days of randomisation. |
| Secondary outcome measure(s) |
In hospital:
1. Death within 30 days 2. Presence of definite or probable DVT in the popliteal or femoral veins detected on a screening Compression Doppler ultrasound scan which had not been suspected clinically before the scan (see below) 3. Definite (i.e. excluding probable DVTs) symptomatic or asymptomatic DVT in the popliteal or femoral veins detected on either a Compression Doppler ultrasound scan, contrast venography or MRI direct thrombus imaging within 30 days of randomisation 4. Any definite or probable symptomatic or asymptomatic DVT (i.e. including DVTs which only involve the calf veins) 5. Confirmed fatal or non-fatal pulmonary embolism (PE) 6. Adherence to allocated treatment At 6 months: 7. Death from any cause 8. Any confirmed symptomatic or asymptomatic DVT or PE occurring between randomisation and final follow up 9. Any symptomatic DVT or PE occurring between randomisation and final follow up 10. Place of residence 11. Post DVT syndrome 12. Disability (modified Rankin) 13. Health related quality of life (EuroQol). The later effects of DVT/PE (e.g., breathlessness, leg pain or swelling, poor stroke recovery) or the adverse events related to IPC (falls with injury, fractures, skin ulceration, amputation, loss of mobility) may be diverse, so it seems sensible to include a measure of overall health related quality of life. |
| Sources of funding |
1. Chief Scientist Office (UK) (ref: CZG\2\378)
Added 20/05/10: 2. NIHR Health Technology Assessment Programme - HTA (UK) (ref: 08/14/03) |
| Trial website | http://www.clotstrial.com |
| Publications | |
| Contact name | Prof Martin Dennis |
| Address |
Bramwell Dott Building
Division of Clinical Neurosciences Western General Hospital Crere Road |
| City/town | Edinburgh |
| Zip/Postcode | EH4 2XU |
| Country | United Kingdom |
| Sponsor | University of Edinburgh (UK) |
| Address |
Edinburgh Clinical Trials Unit
Queens Medical Research Institute 47 Little France Crescent |
| City/town | Edinburgh |
| Zip/Postcode | EH16 4TJ |
| Country | United Kingdom |
| Sponsor website: | http://www.ed.ac.uk |
| Date applied | 26/08/2008 |
| Last edited | 02/08/2010 |
| Date ISRCTN assigned | 09/10/2008 |
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| © 2012 ISRCTN unless otherwise stated. | |
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