The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome
- Conditions
- Deep Venous Thrombosis
- Interventions
- Device: Knee-length, graduated elastic compression stockingDevice: Knee-length, placebo stocking
- Registration Number
- NCT00143598
- Lead Sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Brief Summary
The purpose of this study is to determine whether elastic compression stockings used for 2 years are effective in preventing the post-thrombotic syndrome in patients with symptomatic proximal deep venous thrombosis.
- Detailed Description
The post-thrombotic syndrome (PTS) is a frequent, burdensome and costly condition that occurs in about one third of patients after an episode of deep vein thrombosis (DVT). Affected patients have chronic leg pain and swelling, and sometimes develop skin ulcers. At present, there is little to offer for the treatment of this condition. Prevention of PTS is the key to reducing its burden on patients and society. Elastic compression stockings (ECS) could be helpful in preventing PTS, however data on their effectiveness are scarce and conflicting.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 806
- Consecutive patients with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 14 days (with or without concurrent distal DVT or pulmonary embolism)
- Who have no contraindications to standard treatment with heparin and/or warfarin, and
- Who provide informed consent to participate
- Contraindication to compression stockings
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active ECS Knee-length, graduated elastic compression stocking Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle. Placebo ECS Knee-length, placebo stocking Placebo stockings with identical appearance to Active ECS and with \< 5 mm Hg compression at the ankle.
- Primary Outcome Measures
Name Time Method Incidence of Post-thrombotic Syndrome (PTS) During 2-year follow up
- Secondary Outcome Measures
Name Time Method Incidence of Objectively Confirmed Recurrent Venous Thromboembolism (VTE), Death From VTE and Major Bleeding During 2-year follow up Severity of PTS, Including Incidence of Venous Ulcer 6-24 months. Highest Villalta at or after 6 month visit
The Villalta Scale for assessment of the post-thrombotic syndrome The Villalta scale has a range of 0-33. A Villalta scale score \>4 indicates post-thrombotic syndrome (severity of post-thrombotic syndrome is categorized as 5-9 points, mild; 10-14 points, moderate; \>14 points or presence of an ulcer, severe).
Higher values signify worse outcome. Points on each item in the scale are simply summed to a total score.Quality of Life 24 months The SF-36 is a well-validated generic quality-of-life (QOL) instrument. It includes questions on both physical and mental health. Higher scores indicate a better QOL. The VEINES-QOL is a venous-disease specific QOL measure that consists of 25 items that quantify venous disease effect on QOL, and an embedded symptom sub-questionnaire (VEINES-Sym) with 10 items that measures venous symptoms. Higher scores are associated with better QOL.
The VEINES-QOL/Sym and SF-36 use the standard method for scoring questionnaires with items with different response scales that is now routinely used. Raw scores are first transformed to z score equivalents (mean, 0; standard deviation, 1), which then are transformed to T scores (mean, 50; standard deviation, 10) to give an easily understood range of scores. A person-specific estimate is imputed for any missing item in cases where the patient answered at least 50% of the items in the scale.
Trial Locations
- Locations (25)
The Ottawa Hospital, Civic Campus
🇨🇦Ottawa, Ontario, Canada
University Health Network - Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Henry Ford Health Systerm
🇺🇸Detroit, Michigan, United States
Hamilton Health Sciences - General Hospital
🇨🇦Hamilton, Ontario, Canada
QE II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Sunnybrook & Women's College Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus
🇨🇦Quebec City, Quebec, Canada
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Oklahoma University Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Hamilton Health Sciences - Chedoke Division
🇨🇦Hamilton, Ontario, Canada
Hamilton Health Sciences - Henderson General Hospital
🇨🇦Hamilton, Ontario, Canada
Hôpital Maisonneuve-Rosemont
🇨🇦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
Victoria Heart Institute Foundation
🇨🇦Victoria, British Columbia, Canada
Centre Hospitalier de l'Université de Montréal - Hôpital Notre-Dame
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Pierre-Boucher
🇨🇦Longueuil, Quebec, Canada
Centre Hospitalier de l'Université de Montréal - Hôpital Hôtel-Dieu
🇨🇦Montreal, Quebec, Canada
Hamilton Health Sciences - McMaster University Medical Centre
🇨🇦Hamilton, Ontario, Canada
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada