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 |
| Protocol serial number | G0200013 |
| Sponsor | Medical Research Council (UK) |
| Funders | Chief Scientist Office, Scotland Ref.CZH/4/7 (UK), Chest Heart and Stroke, Scotland Ref. 03/01(UK), Medical Research Council Ref. G0200531(UK) |
- Submission date
- 08/08/2003
- Registration date
- 11/08/2003
- Last edited
- 28/01/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Martin Dennis
Scientific
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 |
|---|---|
| msd@skull.dcn.ed.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(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 |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
- Australia
- Italy
Study participating centre
Dept. of Clinical Neurosciences
Edinburgh
EH4 2XU
United Kingdom
EH4 2XU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| 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 | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
