TY - JOUR
T1 - Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1)
T2 - A multicentre, randomised controlled trial
AU - Trial Steering Committee
AU - MRC and Tyco Healthcare (Covidien)
AU - Independent Data Monitoring Committee
AU - Participating centres
AU - CLOTS Trials Collaboration
AU - CLOTS Trial Co-ordinating Centre
AU - Writing Group
AU - Dennis, Martin
AU - Cranswick, G.
AU - Deary, A.
AU - Fraser, A.
AU - Graham, C.
AU - Grant, S.
AU - Gunkel, A.
AU - Hunter, J.
AU - MacRae, A.
AU - Perry, D.
AU - Soosay, V.
AU - Williams, C.
AU - Williamson, A.
AU - Young, A.
AU - Dennis, M.
AU - Sandercock, P. A.G.
AU - Reid, J.
AU - Graham, C.
AU - Murray, G.
AU - Venables, G.
AU - Rudd, A. G.
AU - Bowler, G.
AU - Cranswick, G.
AU - Dennis, M.
AU - Graham, C.
AU - Lewis, S.
AU - Murray, G.
AU - Reid, J.
AU - Venables, G.
AU - Bowler, G.
AU - Celani, M. G.
AU - Ricci, S.
AU - Lindley, R.
AU - Celani, M. G.
AU - Hautvast, M.
AU - Paterson, M.
AU - Reid, J.
AU - Ting, T.
AU - Baigent, C.
AU - Bamford, J.
AU - Slattery, J.
AU - Beydoun, N.
AU - Romerosa, M.
AU - Royan, A.
AU - Russell, M.
AU - Boers, P.
AU - Millar, R.
AU - Claxton, A.
AU - Hankey, G.
AU - Gubitz, G.
N1 - Funding Information:
The trial was funded by research grants from the Chief Scientist Office of the Scottish Government (reference CZH/4/7), Chest Heart and Stroke Scotland (reference 03/01), and the Medical Research Council of the UK (reference G0200531). The graduated compression stockings were donated to centres by Tyco Healthcare (Covidien) who also trained nursing staff in their sizing, fitting, and monitoring. We thank all the patients and their families who participated in CLOTS, the nursing and radiology staff who assisted at collaborating sites, and the UK stroke research network staff without whom the trial would not have been possible.
PY - 2009/6/6
Y1 - 2009/6/6
N2 - Background Deep vein thrombosis (DVT) and pulmonary embolism are common after stroke. In small trials of patients undergoing surgery, graduated compression stockings (GCS) reduce the risk of DVT. National stroke guidelines extrapolating from these trials recommend their use in patients with stroke despite insufficient evidence. We assessed the Effectiveness of thigh-length GCS to reduce DVT after stroke. Methods In this outcome-blinded, randomised controlled trial, 2518 patients who were admitted to hospital within 1 week of an acute stroke and who were immobile were enrolled from 64 centres in the UK, Italy, and Australia. Patients were allocated via a central randomisation system to routine care plus thigh-length GCS (n=1256) or to routine care plus avoidance of GCS (n=1262). A technician who was blinded to treatment allocation undertook compression Doppler ultrasound of both legs at about 7-10 days and, when practical, again at 25-30 days after enrolment. The primary outcome was the occurrence of symptomatic or asymptomatic DVT in the popliteal or femoral veins. Analyses were by intention to treat. This study is registered, number ISRCTN28163533. Findings All patients were included in the analyses. The primary outcome occurred in 126 (10.0%) patients allocated to thigh-length GCS and in 133 (10.5%) allocated to avoid GCS, resulting in a non-significant absolute reduction in risk of 0.5% (95% CI -1.9% to 2.9%). Skin breaks, ulcers, blisters, and skin necrosis were significantly more common in patients allocated to GCS than in those allocated to avoid their use (64 [5%] vs 16 [1%]; odds ratio 4.18, 95% CI 2.40-7.27). Interpretation These data do not lend support to the use of thigh-length GCS in patients admitted to hospital with acute stroke. National guidelines for stroke might need to be revised on the basis of these results. Funding Medical Research Council (UK), Chief Scientist Office of Scottish Government, Chest Heart and Stroke Scotland, Tyco Healthcare (Covidien) USA, and UK Stroke Research Network.
AB - Background Deep vein thrombosis (DVT) and pulmonary embolism are common after stroke. In small trials of patients undergoing surgery, graduated compression stockings (GCS) reduce the risk of DVT. National stroke guidelines extrapolating from these trials recommend their use in patients with stroke despite insufficient evidence. We assessed the Effectiveness of thigh-length GCS to reduce DVT after stroke. Methods In this outcome-blinded, randomised controlled trial, 2518 patients who were admitted to hospital within 1 week of an acute stroke and who were immobile were enrolled from 64 centres in the UK, Italy, and Australia. Patients were allocated via a central randomisation system to routine care plus thigh-length GCS (n=1256) or to routine care plus avoidance of GCS (n=1262). A technician who was blinded to treatment allocation undertook compression Doppler ultrasound of both legs at about 7-10 days and, when practical, again at 25-30 days after enrolment. The primary outcome was the occurrence of symptomatic or asymptomatic DVT in the popliteal or femoral veins. Analyses were by intention to treat. This study is registered, number ISRCTN28163533. Findings All patients were included in the analyses. The primary outcome occurred in 126 (10.0%) patients allocated to thigh-length GCS and in 133 (10.5%) allocated to avoid GCS, resulting in a non-significant absolute reduction in risk of 0.5% (95% CI -1.9% to 2.9%). Skin breaks, ulcers, blisters, and skin necrosis were significantly more common in patients allocated to GCS than in those allocated to avoid their use (64 [5%] vs 16 [1%]; odds ratio 4.18, 95% CI 2.40-7.27). Interpretation These data do not lend support to the use of thigh-length GCS in patients admitted to hospital with acute stroke. National guidelines for stroke might need to be revised on the basis of these results. Funding Medical Research Council (UK), Chief Scientist Office of Scottish Government, Chest Heart and Stroke Scotland, Tyco Healthcare (Covidien) USA, and UK Stroke Research Network.
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U2 - 10.1016/S0140-6736(09)60941-7
DO - 10.1016/S0140-6736(09)60941-7
M3 - Article
C2 - 19477503
AN - SCOPUS:66149181762
SN - 0140-6736
VL - 373
SP - 1958
EP - 1965
JO - The Lancet
JF - The Lancet
IS - 9679
ER -