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CLOTS 3. Multicentre randomised trial to evaluate Intermittent Pneumatic Compression in patients with acute stroke. Martin Dennis on behalf of The CLOTS trials collaboration. Venous thromboembolism after stroke. PE. DVT 20%. 5% symptomatic. PE 10% on screening MRI
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CLOTS 3 Multicentre randomised trial to evaluate Intermittent Pneumatic Compression in patients with acute stroke Martin Dennis on behalf of The CLOTS trials collaboration
Venous thromboembolism after stroke PE DVT 20% 5% symptomatic PE 10% on screening MRI Diagnosed in <3%
Background • Graduated compression stockings • reduce the risk of DVT in surgical patients • do not reduce risk of DVT in stroke (CLOTS 1) • Intermittent Pneumatic Compression • reduce the risks of DVT in surgical patients • not adequately tested in stroke or medical patients
Research Question Does IPC reduce the frequency of DVT after stroke?
Immobile Stroke patient Day 0-3 of admission Routine care & No IPC Duplex of both legs at 7-10 days Duplex of both legs at 25-30 days 6 months follow up CLOTS 3 Routine care & IPC
CLOTS 3 - Conduct • 2876 enrolled by 105 centres in UK • Dec 2008 to Sept 2012 • Excellent balance for all baseline variables & post enrolment anti-thrombotics
CLOTS 3 – EfficacyPrimary outcome % P=0.001 Proximal DVT
No IPC IPC Cumulative Hazard Hazard Ratio = 0.86 (95%CI 0.73 - 0.99) p=0.042 Survival time (days) Probability of Death within 6 months
Conclusions • IPC is feasible and safe • IPC is an effective form of VTE prophylaxis NNT = 28 for proximal DVT • It probably improves overall survival NNT~ 43 for death in 30 days • Effective in ischaemic & haemorrhagic stroke
More details available Expedited publication today at http://www.thelancet.com/