The CLOTS 3 trial: a randomised controlled trial to determine whether intermittent pneumatic compression reduces the risk of post stroke deep vein thrombosis.

Deep vein thrombosis (DVT) is common in immobile patients with a recent stroke. Anticoagulants increase the risk of bleeding which offsets their benefits with respect to DVT prevention. CLOTS Trial 1 has shown that graduated compression stockings (GCS) do not reduce the risk of post stroke DVT. Intermittent pneumatic compression (IPC) reduces the risk of DVT after surgery by about 60%. It is relatively safe, compared with anticoagulants, and offers a potentially useful method to reduce the risk of DVT and pulmonary embolism in stroke patients. A systematic review of all randomised trials of IPC after stroke suggests it is practical, acceptable to patients and may be effective. The CLOTS 3 trial is testing IPC in immobile stroke patients. Primary Research Questions Does early and routine application of IPC, in addition to routine care, reduce the risk of above knee DVT in the weeks following an acute stroke? Is IPC a practical and acceptable treatment for DVT prevention on stroke units? Inclusion Criteria Any patient who is admitted to hospital within three days of a clinical stroke and, who is unable to mobilise independently. Sample size & Analyses The trial aims to enrol at least 2000 patients. All analyses will be based on an intention to treat. Primary outcome Presence of definite or probable symptomatic or asymptomatic DVT in the popliteal or femoral veins detected on a screening compression duplex ultrasound scan or any symptomatic DVT in the popliteal or femoral veins confirmed on compression duplex ultrasound or contrast venography or MRI direct thrombus imaging within 30 days of randomisation.