The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome

Phase 3

Completed

Conditions: Deep Venous Thrombosis

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

Inclusion Criteria

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

Exclusion Criteria

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

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): 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
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Henry Ford Health Systerm
🇺🇸Detroit, Michigan, United States