A Randomised Trial to Establish the Effectiveness of Intermittent Pneumatic Compression to Prevent Post Stroke Deep Vein Thrombosis (DVT).

Design: Multicentre randomised controlled trial with observer blinded assessment of the primary outcome.

Setting: Stroke units in the UK. Identification of eligible patients, consent, recruitment, delivery and monitoring of allocated treatment will occur within the unit. Screening compression doppler ultrasounds will occur in the radiology department or vascular laboratory mainly during hospital admission although in the minority of patients who are discharged from hospital they may have these tests as an outpatient. Six month follow up will occur in their place of residence via a postal or telephone questionnaire.

Target population: Patients (16 years or over) admitted to hospital with an acute stroke who are immobile and therefore at significant risk of developing a deep venous thrombosis.

Health technologies being assessed: The trial will compare the outcomes of patients receiving Routine care plus Intermittent Pneumatic Compression (IPC) vs. Routine care and avoiding IPC. Patients allocated to IPC will be fitted with thigh length IPC sleeves although if these are not well tolerated, for instance because of heavy soiling due to faecal incontinence, below knee sleeves can be substituted. Ideally IPC will be worn both day and night for 30 days from randomisation OR until a second screening doppler ultrasound (if after 30 days). Routine care is likely to include general measures to reduce risk of DVT including, adequate hydration, routine use of aspirin in patients with ischaemic stroke and early mobilisation. It may also include routine use of graduated compression stockings (GCS) if these are shown to be effective in the ongoing CLOTS Trials 1 & 2. Participating centres will be asked to ensure that the standard care specific to their institution is applied equally rigorously to patients in the trial irrespective of their treatment allocation. Collaborators will be permitted to use these interventions where they feel this is clinically justified - we will monitor use of antithrombotics and GCS to ensure it is balanced in the two treatment arms.

Measurement of costs and outcomes: The primary outcome will be the "presence of definite or probable symptomatic or asymptomatic DVT in the veins behind the knee or in the thigh detected on either of two screening compression Doppler ultrasound scans (performed at about 7-10 days and 25 - 30 days as part of the research) or contrast venography or MRI(only if clinically indicated) within 30 days of randomisation". This is regarded as a clinically important outcome, acceptable to patients and staff and has been shown to be practical to collect in the vast majority of patients in the ongoing CLOTS Trials 1 & 2. Secondary outcomes measured in hospital and collected at hospital discharge by reviewing the casenotes will include: death within 30 days; 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,Definite (i.e. excluding probable DVTs) symptomatic or asymptomatic DVT in the popliteal or femoral veins detected on either a Compression Doppler ultrasound scan or contrast venography or MRI direct thrombus imaging within 30 days of randomisation; Any definite or probable symptomatic or asymptomatic DVT (i.e. including DVTs which only involve the calf veins); Confirmed fatal or non-fatal PE; Adherence to allocated treatment.