Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): A multicentre, randomised controlled trial

Trial Steering Committee; MRC and Tyco Healthcare (Covidien); Independent Data Monitoring Committee; Participating centres; CLOTS Trials Collaboration; CLOTS Trial Co-ordinating Centre; Writing Group

doi:10.1016/S0140-6736(09)60941-7

Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): A multicentre, randomised controlled trial

Trial Steering Committee
, MRC and Tyco Healthcare (Covidien)
, Independent Data Monitoring Committee
, Participating centres
, CLOTS Trials Collaboration
, CLOTS Trial Co-ordinating Centre
, Writing Group

University of Edinburgh
St Thomas' Hospital
Westmead Hospital
John Hunter Hospital
St George Hospital
Royal Perth Hospital
QEII Health Sciences Centre
District Hospital Pardubice
St John's Medical College and Research Institute
Mullingar Regional Hospital
St Vincent’s University Hospital
Universita di Sassari
Ospedale Beato Giacomo Villa-Citta'della Pieve
Ospedale Citta di Castello-Perugia
UO Chirurgia Generale - Ospedale Maggiore Di Cremona
Ospedale A.Segni
Blackpool Victoria Hospital
Policlinico Universitario G Martino
San Matteo Degli Infermi-Spoleto
Sant’Andrea University Hospital
Cattinara University Hospital
Ospedale S. Giovanni Battista
Instituto Nacional de Neurología y Neurocirugía
Santa Maria University Hospital
Western General Hospital
Mid Yorkshire Hospitals NHS Trust
Leeds General Infirmary
Eastbourne District General Hospital
Calderdale Royal Hospital
Luton and Dunstable Hospital
Royal Infirmary of Edinburgh
North Tyneside General Hospital
Borders General Hospital
West Cumberland Hospital
Weston General Hospital
Harrogate District Hospital
Bradford Teaching Hospitals NHS Foundation Trust
Broomfield Hospital
Aintree University Hospital
Countess of Chester Hospital NHS Foundation Trust
Royal Gwent Hospital
General Hospital
Watford General Hospital
University Hospitals Coventry and Warwickshire NHS Trust
Norfolk and Norwich University Hospitals NHS Foundation Trust
Gloucestershire Royal Hospital
Hairmyres Hospital
Worcestershire Royal Hospital
Airedale General Hospital
Ashford and St Peter Hospitals NHS Trust
Derbyshire Royal Infirmary
Poole Hospital NHS Foundation Trust
Queen Elizabeth Hospital
Lorn and Islands District General Hospital
William Harvey Hospital
Hope Hospital
Royal Preston Hospital
University Hospital of South Manchester
Selly Oak Hospital
Torbay Hospital
James Cook University Hospital
Royal London Hospital
Queen Margaret Hospital
Queen's Hospital Burton
Mid Staffordshire NHS Foundation Trust
East Kent Hospitals University NHS Foundation Trust
Southport and Ormskirk Hospital NHS Trust
Salisbury District Hospital
Hexham Hospital
South Tyneside General Hospital
NHS Greater Glasgow and Clyde
Charing Cross Hospital
Derby City General Hospital
Raigmore Hospital
Kent and Canterbury Hospital
Chesterfield Royal Hospital
Hemel Hempstead Hospital
Manchester University Hospitals NHS Foundation Trust
Kettering General Hospital
Royal Cornwall Hospital
Stirling Royal Infirmary
University Hospital of North Durham
Fairfield General Hospital
King's College Hospital
Lincoln County Hospital
Doncaster Royal Infirmary
Sunderland Royal Hospital
Southend University Hospital
Derriford Hospital
St John's Hospital
St Helens and Knowsley Hospital
Isle of Wight NHS Trust
John Radcliffe Hospital
Ayr Hospital
Barnsley Hospital
Yeovil District Hospital
University Hospital of North Staffordshire
Aberdeen Royal Infirmary
Cumberland Infirmary
Rotherham Hospital
Brighton and Sussex University Hospitals
Arrowe Park Hospital
East Birmingham Hospital
Nottingham City Hospital
Macclesfield District General Hospital
Royal Liverpool Hospital
Royal Berkshire Hospital
Newham University Hospital
Bishop Auckland General Hospital
Belfast City Hospital
King's Mill Hospital
County Hospital Hereford
Royal Edward Albert Infirmary
North Manchester General Hospital
George Eliot Hospital NHS Trust
Musgrove Park Hospital
Lister Hospital
Manchester Royal Infirmary
Hull Royal Infirmary
Bristol Royal Infirmary
Warwick Hospital
C/o Pilgrim Hospital
Morriston Hospital
Northern General Hospital
York Health Services NHS Trust
Queens Park Hospital Blackburn
Royal United Hospital
Glasgow Royal Infirmary
Perth Royal Infirmary
Royal Shrewsbury Hospital
Hampshire Hospitals NHS Foundation Trust
General Medicine and Medical Audit, University Hospital of Wales
University Hospital of Hartlepool
Lewisham and Greenwich NHS Trust
Solihull Hospital
Ulster Hospital
University College of London Hospitals

Research output: Contribution to a Journal (Peer & Non Peer) › Article › peer-review

398 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	1958-1965
Number of pages	8
Journal	The Lancet
Volume	373
Issue number	9679
DOIs	https://doi.org/10.1016/S0140-6736(09)60941-7
Publication status	Published - 6 Jun 2009
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Access to Document

10.1016/S0140-6736(09)60941-7

Cite this

Trial Steering Committee, MRC and Tyco Healthcare (Covidien), Independent Data Monitoring Committee, Participating centres, CLOTS Trials Collaboration, CLOTS Trial Co-ordinating Centre, & Writing Group (2009). Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): A multicentre, randomised controlled trial. The Lancet, 373(9679), 1958-1965. https://doi.org/10.1016/S0140-6736(09)60941-7

@article{02ae690fcc77424596a6032525002372,

title = "Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): A multicentre, randomised controlled trial",

abstract = "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.",

author = "\{Trial Steering Committee\} and \{MRC and Tyco Healthcare (Covidien)\} and \{Independent Data Monitoring Committee\} and \{Participating centres\} and \{CLOTS Trials Collaboration\} and \{CLOTS Trial Co-ordinating Centre\} and \{Writing Group\} and Martin Dennis and G. Cranswick and A. Deary and A. Fraser and C. Graham and S. Grant and A. Gunkel and J. Hunter and A. MacRae and D. Perry and V. Soosay and C. Williams and A. Williamson and A. Young and M. Dennis and Sandercock, \{P. A.G.\} and J. Reid and C. Graham and G. Murray and G. Venables and Rudd, \{A. G.\} and G. Bowler and G. Cranswick and M. Dennis and C. Graham and S. Lewis and G. Murray and J. Reid and G. Venables and G. Bowler and Celani, \{M. G.\} and S. Ricci and R. Lindley and Celani, \{M. G.\} and M. Hautvast and M. Paterson and J. Reid and T. Ting and C. Baigent and J. Bamford and J. Slattery and N. Beydoun and M. Romerosa and A. Royan and M. Russell and P. Boers and R. Millar and A. Claxton and G. Hankey and G. Gubitz and J. Jarrett and K. Legg and M. MacKay and S. Nearing and S. Phillips and E. Ehler and P. Geier and M. Mrklovsk{\'y} and Anandan, \{A. M.\} and G. Kusumakar and J. Rosario and Roy, \{A. K.\} and C. Duff and E. Farrelly and M. Jadrnickova and L. Masterson and J. Morris and M. Crowe and I. Noone and Fancello, \{M. A.\} and Parish, \{L. D.\} and P. Pileri and M. Pinna and Piras, \{M. P.\} and A. Pirisi and C. Scodino and Zedde, \{M. L.\} and V. Bondo and D. Capecchi and Celani, \{M. G.\} and S. Cupella and L. Guerra and A. Macchitella and C. Ottaviani and E. Righetti and C. Rossi and Scucchi, \{M. G.\} and V. Stefanini and A. Tufi and A. Barilaro and S. Cenciarelli and S. Dioguardi and E. Gallinella and L. Greco and A. Mattioni and T. Mazzoli and S. Ricci and G. Procaccianti and P. Beccu and O'Donnell, \{M. J.\}",

year = "2009",

month = jun,

day = "6",

doi = "10.1016/S0140-6736(09)60941-7",

language = "English",

volume = "373",

pages = "1958--1965",

journal = "The Lancet",

issn = "0140-6736",

publisher = "Elsevier B.V.",

number = "9679",

}

Trial Steering Committee, MRC and Tyco Healthcare (Covidien), Independent Data Monitoring Committee, Participating centres, CLOTS Trials Collaboration, CLOTS Trial Co-ordinating Centre & Writing Group 2009, 'Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): A multicentre, randomised controlled trial', The Lancet, vol. 373, no. 9679, pp. 1958-1965. https://doi.org/10.1016/S0140-6736(09)60941-7

Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): A multicentre, randomised controlled trial. / Trial Steering Committee; MRC and Tyco Healthcare (Covidien); Independent Data Monitoring Committee et al.
In: The Lancet, Vol. 373, No. 9679, 06.06.2009, p. 1958-1965.

Research output: Contribution to a Journal (Peer & Non Peer) › Article › peer-review

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.

AU - Jarrett, J.

AU - Legg, K.

AU - MacKay, M.

AU - Nearing, S.

AU - Phillips, S.

AU - Ehler, E.

AU - Geier, P.

AU - Mrklovský, M.

AU - Anandan, A. M.

AU - Kusumakar, G.

AU - Rosario, J.

AU - Roy, A. K.

AU - Duff, C.

AU - Farrelly, E.

AU - Jadrnickova, M.

AU - Masterson, L.

AU - Morris, J.

AU - Crowe, M.

AU - Noone, I.

AU - Fancello, M. A.

AU - Parish, L. D.

AU - Pileri, P.

AU - Pinna, M.

AU - Piras, M. P.

AU - Pirisi, A.

AU - Scodino, C.

AU - Zedde, M. L.

AU - Bondo, V.

AU - Capecchi, D.

AU - Celani, M. G.

AU - Cupella, S.

AU - Guerra, L.

AU - Macchitella, A.

AU - Ottaviani, C.

AU - Righetti, E.

AU - Rossi, C.

AU - Scucchi, M. G.

AU - Stefanini, V.

AU - Tufi, A.

AU - Barilaro, A.

AU - Cenciarelli, S.

AU - Dioguardi, S.

AU - Gallinella, E.

AU - Greco, L.

AU - Mattioni, A.

AU - Mazzoli, T.

AU - Ricci, S.

AU - Procaccianti, G.

AU - Beccu, P.

AU - O'Donnell, M. J.

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.

UR - https://www.scopus.com/pages/publications/66149181762

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 -

Trial Steering Committee, MRC and Tyco Healthcare (Covidien), Independent Data Monitoring Committee, Participating centres, CLOTS Trials Collaboration, CLOTS Trial Co-ordinating Centre et al. Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): A multicentre, randomised controlled trial. The Lancet. 2009 Jun 6;373(9679):1958-1965. doi: 10.1016/S0140-6736(09)60941-7

Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): A multicentre, randomised controlled trial

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