Stroke Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
Routine care vs routine care plus IPC sleeves. If allocated to the intervention group, thigh length IPC sleeves should be applied to both legs for 30 days.
Sponsors
University of Edinburgh (UK)
Lothian NHS Board (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Current information as of 20/05/2010: 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 years 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 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed