The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome
NCT ID: NCT00143598
Last Updated: 2014-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
806 participants
INTERVENTIONAL
2004-06-30
2012-02-29
Brief Summary
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Detailed Description
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Comparison(s): Knee-length, 30-40 mm Hg (Class II), graduated ECS worn on the DVT-affected leg daily for 2 years compared to knee-length, inactive (i.e. no compression) stocking, identical in appearance to active ECS, worn on the DVT-affected leg daily for 2 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Active ECS
Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
Knee-length, graduated elastic compression stocking
Worn daily for 2 years, 30-40 mm Hg
Placebo ECS
Placebo stockings with identical appearance to Active ECS and with \< 5 mm Hg compression at the ankle.
Knee-length, placebo stocking
Worn daily for two years
Interventions
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Knee-length, graduated elastic compression stocking
Worn daily for 2 years, 30-40 mm Hg
Knee-length, placebo stocking
Worn daily for two years
Eligibility Criteria
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Inclusion Criteria
* Who have no contraindications to standard treatment with heparin and/or warfarin, and
* Who provide informed consent to participate
Exclusion Criteria
* Limited lifespan (estimated \< 6 months)
* Geographic inaccessibility preventing return for follow-up visits
* Inability to apply stockings daily and unavailability of a caregiver to apply stockings daily
* Treatment of acute DVT with thrombolytic agents
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Sigvaris Corporation
INDUSTRY
Sir Mortimer B. Davis - Jewish General Hospital
OTHER
Responsible Party
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Dr. Susan Kahn
SOX Trial Principal Investigator
Principal Investigators
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Susan R. Kahn, M.D., M.Sc.
Role: PRINCIPAL_INVESTIGATOR
Sir Mortimer B. Davis - Jewish General Hospital
Locations
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Henry Ford Health Systerm
Detroit, Michigan, United States
Duke University Medical Center
Durham, North Carolina, United States
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada
Hamilton Health Sciences - General Hospital
Hamilton, Ontario, Canada
Hamilton Health Sciences - Chedoke Division
Hamilton, Ontario, Canada
Hamilton Health Sciences - McMaster University Medical Centre
Hamilton, Ontario, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Hamilton Health Sciences - Henderson General Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital, Civic Campus
Ottawa, Ontario, Canada
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, Canada
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada
Centre Hospitalier Pierre-Boucher
Longueuil, Quebec, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal - Hôpital Notre-Dame
Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal - Hôpital Hôtel-Dieu
Montreal, Quebec, Canada
Royal Victoria Hospital - McGill University Health Centre
Montreal, Quebec, Canada
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, Canada
St. Mary's Hospital Center
Montreal, Quebec, Canada
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, Canada
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada
Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus
Québec, Quebec, Canada
Countries
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References
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Kahn SR, Shbaklo H, Shapiro S, Wells PS, Kovacs MJ, Rodger MA, Anderson DR, Ginsberg JS, Johri M, Tagalakis V; SOX Trial Investigators. Effectiveness of compression stockings to prevent the post-thrombotic syndrome (the SOX Trial and Bio-SOX biomarker substudy): a randomized controlled trial. BMC Cardiovasc Disord. 2007 Jul 24;7:21. doi: 10.1186/1471-2261-7-21.
Kahn SR, Shapiro S, Wells PS, Rodger MA, Kovacs MJ, Anderson DR, Tagalakis V, Houweling AH, Ducruet T, Holcroft C, Johri M, Solymoss S, Miron MJ, Yeo E, Smith R, Schulman S, Kassis J, Kearon C, Chagnon I, Wong T, Demers C, Hanmiah R, Kaatz S, Selby R, Rathbun S, Desmarais S, Opatrny L, Ortel TL, Ginsberg JS; SOX trial investigators. Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial. Lancet. 2014 Mar 8;383(9920):880-8. doi: 10.1016/S0140-6736(13)61902-9. Epub 2013 Dec 6.
Kahn SR, Shapiro S, Ducruet T, Wells PS, Rodger MA, Kovacs MJ, Anderson D, Tagalakis V, Morrison DR, Solymoss S, Miron MJ, Yeo E, Smith R, Schulman S, Kassis J, Kearon C, Chagnon I, Wong T, Demers C, Hanmiah R, Kaatz S, Selby R, Rathbun S, Desmarais S, Opatrny L, Ortel TL, Galanaud JP, Ginsberg JS. Graduated compression stockings to treat acute leg pain associated with proximal DVT. A randomised controlled trial. Thromb Haemost. 2014 Dec;112(6):1137-41. doi: 10.1160/TH14-05-0430. Epub 2014 Aug 28.
Related Links
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Biomarker Sub Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX) Trial (Bio-SOX)
Other Identifiers
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ISRCTN71334751
Identifier Type: REGISTRY
Identifier Source: secondary_id
MCT-63142
Identifier Type: -
Identifier Source: org_study_id
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