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CLOTS 3.The role of IPC! Background • VTE common, potentially avoidable cause of death in hospitalised patients. • Stroke patients at considerable risk. VTE incidence of 20-42% in previous studies • NICE(2010) guideline recommend ‘”Selective” use of anticoagulants in stroke patients with high VTE risk & low bleeding risk. ?!!!!!- Difficult to achieve in practice • PE accounts for 25% early death after stroke • Approx 50% hemiplegic stroke patients will have DVT within 2 weeks if not treated- 1/3 will be proximal • Peak incidence 2-7 days post event . • Often clinically silent!!! American Heart Association • Large randomised trials shown no net benefit from the use of LMWH in stroke patients. • CLOTS 1&2 studies showed AES were not effective in stroke patientscaused harm? • Good evidence for IPC in surgical (including neuro) patients. Benefits not proven in medical patients CLOTS 3 Study objective : “The CLOTS 3 trial aimed to establish whether the routine application of IPC to the legs of immobile patients who had stroke reduced their risk of DVT.” Intermittent pneumatic compression Pressure is applied to the leg reducing diameter of leg vein and increasing venous velocity Increased velocity increases deep venous pressure allowing blood to return into cardiac circulation. Increases blood flow 240% of baseline (Nicolaides et al) Assists fibrinolysis Study design • Multicentred, parallel group RCT • Patients enrolled day 0-3 of admission. Randomised to IPC or no IPC • Duplex ultrasound both legs by blinded technician Day 7-10 and again days 2530( focussed on detecting proximal DVT) • Follow up at 6months to determine survival or later symptomatic DVT Patients characteristics similar in both arms- took into account • Delay since stroke onset • Severity • Leg weakness • Already on anticoagulation Inclusion Criteria Immobile patients admitted into hospital within 3 days of Acute stroke. Exclusion • Age<16 . • Subarachnoid haemorrhage • Contraindication To IPC Outcomes • IPC resulted in a statistically significant reduction (29.9%) of proximal DVTs in immobile stroke patients • Survival to six months was also statistically significant, with a 14% reduction in mortality risk • Adverse effects due to the use of IPC were rare IPC is safe and effective in reducing the risk of DVT and possibly improves survival in immobile stroke patients Implications for practice • Clear Evidence IPC applied to immobile stroke patients is safe and reduces the risk of all DVT • As effective in haemorrhagic stroke as thrombotic • Improved survival rates ? Reduction in undiagnosed PE • Reasonably well tolerated • Likely to be effective in other high risk medical patients The Lancet, Volume 382, Issue 9891, Pages 516 - 524, 10 August 2013 Tracy Graham University Hospital SouthamptonAnticoagulation &Thrombophilia CNS [email protected]