Does intermittent pneumatic compression reduce the risk of post stroke deep vein thrombosis? The CLOTS 3 trial: Study protocol for a randomized controlled trial

Trials

Volumn 13, Issue , 2012, Pages

  Dennis, Martin ^a,d,d   Sandercock, Peter ^a,d   Reid, John ^b,d,d   Graham, Catriona ^a   Forbes, John ^c,d,d   Cranswick, Gina ^d   Hunter, Janie ^d   Williams, Carol ^d   Soosay, Vera ^d   Deary, Ann ^d   Fraser, Anne ^d   McGrath, Aileen ^d   Young, Adam ^d   Bowler, Gill ^d   Henderson, Yvette ^d   Rudd, Anthony ^d   Lowe, Gordon ^d   Murray, Gordon ^d   Bucukoglu, Marise ^d   McLelland, Tina ^d   Bamford, John ^d   Slattery, Jim ^d   Baigent, Colin ^d   more..

^a UNIVERSITY OF EDINBURGH   (United Kingdom)

^b BORDERS GENERAL HOSPITAL   (United Kingdom)

^c UNIVERSITY OF EDINBURGH   (United Kingdom)

^d NONE

Author keywords

Complications; Deep vein thrombosis; Intermittent pneumatic compression; Prevention; Stroke

Indexed keywords

ADULT; ARTICLE; CARDIOVASCULAR RISK; CAREGIVER; COMPRESSION THERAPY; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DOPPLER ECHOGRAPHY; FEMORAL VEIN; HEALTH ECONOMICS; HOSPITAL ADMISSION; HUMAN; INTERMITTENT PNEUMATIC COMPRESSION DEVICE; LUNG EMBOLISM; MEDICAL CARE; MULTICENTER STUDY; POPLITEAL VEIN; QUALITY OF LIFE; RADIOLOGIST; RANDOMIZED CONTROLLED TRIAL; STROKE; STROKE PATIENT; TREATMENT OUTCOME; UNITED KINGDOM; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; COST BENEFIT ANALYSIS; DISABILITY; ECHOGRAPHY; ECONOMICS; HEALTH CARE COST; METHODOLOGY; PREDICTIVE VALUE; QUESTIONNAIRE; STATISTICAL MODEL; TIME; VEIN THROMBOSIS;

COST-BENEFIT ANALYSIS; DISABILITY EVALUATION; FEMORAL VEIN; GREAT BRITAIN; HEALTH CARE COSTS; HUMANS; INTERMITTENT PNEUMATIC COMPRESSION DEVICES; MODELS, ECONOMIC; POPLITEAL VEIN; PREDICTIVE VALUE OF TESTS; QUESTIONNAIRES; RESEARCH DESIGN; STROKE; TIME FACTORS; TREATMENT OUTCOME; ULTRASONOGRAPHY, DOPPLER, DUPLEX; VENOUS THROMBOSIS;

EID: 84857957531     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-13-26     Document Type: Article

References (22)

1. House of Commons Health Committee The Prevention of Venous Thromboembolism in Hospitalised Patients. Second Report of Session 2004-05 Repor, HC 99 2005, London: The Stationery Office Limited, House of Commons Health Committee.
2. Kelly J, Rudd A, Lewis RR, Coshall C, Moody A, Hunt BJ. Venous thromboembolism after acute ischemic stroke: a prospective study using magnetic resonance direct thrombus imaging. Stroke 2004, 35:2320-2325. 10.1161/01.STR.0000140741.13279.4f, 15322298.
3. CLOTS Trials Collaboration 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. Lancet 2009, 373:1958-1965. 2692021, 19477503, CLOTS Trials Collaboration.
4. Bounds JV, Wiebers DO, Whisnant JP, Okazaki H. Mechanisms and timing of deaths from cerebral infarction. Stroke 1981, 12:474-477. 10.1161/01.STR.12.4.474, 7314170.
5. Sandercock PAG, Counsell C, Kamal AK. Anticoagulants for acute ischaemic stroke. Cochrane Database Syst Rev 2008, (4). Art. No.: CD000024. DOI: 10.1002/14651858.CD000024.pub3.
6. Davenport RJ, Dennis MS, Wellwood I, Warlow CP. Complications following acute stroke. Stroke 1996, 27:415-420. 10.1161/01.STR.27.3.415, 8610305.
7. Warlow C, Ogston D, Douglas AS. Deep venous thrombosis of the legs after strokes. Part 1. Incidence and predisposing factors. BMJ 1976, 1:1178-1181. 10.1136/bmj.1.6019.1178, 1639761, 1268614.
8. International Stroke Trial Collaborative Group The International Stroke Trial (IST) A randomised trial of aspirin, subcutaneous heparin, both or neither among 19435 patients with acute ischaemic stroke. Lancet 1997, 349:1569-1581. International Stroke Trial Collaborative Group.
9. Sherman DG, Albers GW, Bladin C, Fieschi C, Gabbai AA, Kase CS, O'Riordan W, Pineo GF, . PREVAIL Investigators The efficacy and safety of enoxaparin versus unfractionated heparin for the prevention of venous thromboembolism after acute ischaemic stroke (PREVAIL Study): an open-label randomised comparison. Lancet 2007, 369:1347-1355. 10.1016/S0140-6736(07)60633-3, 17448820, PREVAIL Investigators.
10. Ricci S, Celani MG, Righetti E, Dennis M, Sandercock P. Prevention of venous thromboembolism after acute ischaemic stroke. Lancet 2007, 370:735-736.
11. Agu O, Hamilton G, Baker D. Graduated compression stockings in the prevention of venous thromboembolism. Br J Surg 1999, 86:992-1004. 10.1046/j.1365-2168.1999.01195.x, 10460633.
12. Roderick P, Ferris G, Wilson K, Halls H, Jackson D, Collins R, Baigent C. Towards evidence-based guidelines for the prevention of venous thromboembolism: systematic reviews of mechanical methods, oral anticoagulation, dextran and regional anaesthesia as thromboprophylaxis. Health Technol Assess 2005, 9:1-93.
13. Naccarato M, Chiodo Grandi F, Dennis M, Sandercock PAG. Physical methods for preventing deep vein thrombosis in stroke. Cochrane Database Syst Rev 2010, (8). Art. No.: CD001922. DOI: 10.1002/14651858.CD001922.pub3.
14. The CLOTS Trials Collaboration Thigh-length versus below-knee stockings for DVT prophylaxis after stroke: a randomized trial. Ann Int Med 2010, 153:553-562. The CLOTS Trials Collaboration.
15. Counsell C, Dennis M, McDowall M, Warlow C. Predicting outcome after acute stroke: development and validation of new models. Stroke 2002, 33:1041-1047. 10.1161/hs0402.105909, 11935058.
16. Altman DG, Bland JM. Treatment allocation by minimisation. BMJ 2005, 330:843. 10.1136/bmj.330.7495.843, 556084, 15817555.
17. Davidson BL. What are the most reliable detection methods for deep vein thrombosis and pulmonary embolism to be used as endpoints in trials of venous thromboprophylaxis?. Haemostasis 1998, 28(Suppl 3):113-119.
18. Kearon C. Natural history of venous thromboembolism. Circulation 2003, 107:I22-I30.
19. Dennis M, Wellwood I, Warlow C. Are simple questions a valid measure of outcome after stroke?. Cerebro Vasc Dis 1997, 7:22-27.
20. Bamford JL, Sandercock PAG, Warlow CP, Slattery J. Interobserver agreement for the assessment of handicap in stroke patients (letter). Stroke 1989, 20:828. 10.1161/01.STR.20.6.828, 2728057.
21. EUROQoL Group EUROQoL - A new facility for the measurement of health related quality of life. Health Policy 1990, 16:199-208. EUROQoL Group.
22. Buyse M, George SL, Evans S, Geller NL, Ranstam J, Scherrer B, Lesaffre E, Murray G, Edler L, Hutton J, Colton T, Lachenbruch P, Verma BL, . for the ISCB Subcommittee On Fraud The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials statist. Med 1999, 18:3435-3451. for the ISCB Subcommittee On Fraud.