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

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Sigvaris Corporation
Information provided by (Responsible Party):
Dr. Susan Kahn, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT00143598
First received: September 1, 2005
Last updated: August 15, 2014
Last verified: August 2014

September 1, 2005
August 15, 2014
June 2004
February 2012   (final data collection date for primary outcome measure)
Incidence of Post-thrombotic Syndrome (PTS) [ Time Frame: During 2-year follow up ] [ Designated as safety issue: No ]
Incidence of PTS during 2-year follow up.
Complete list of historical versions of study NCT00143598 on ClinicalTrials.gov Archive Site
  • Severity of PTS, Including Incidence of Venous Ulcer [ Time Frame: 6-24 months. ] [ Designated as safety issue: No ]

    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.

  • Incidence of Objectively Confirmed Recurrent Venous Thromboembolism (VTE), Death From VTE and Major Bleeding [ Time Frame: During 2-year follow up ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    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.

  • Severity of PTS during 2-year follow up, including incidence of venous ulcer
  • Incidence of objectively confirmed recurrent VTE, death from VTE and major bleeding over 2 years
  • C-reactive protein at 30 days compared to baseline value
  • Quality of life over the 2-year follow up
  • Cost-effectiveness.
Not Provided
Not Provided
 
The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome
The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome After Symptomatic Proximal Deep Venous Thrombosis

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Deep Venous Thrombosis
  • Device: Knee-length, graduated elastic compression stocking
    Worn daily for 2 years, 30-40 mm Hg
  • Device: Knee-length, placebo stocking
    Worn daily for two years
  • Active Comparator: Active ECS
    Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
    Intervention: Device: Knee-length, graduated elastic compression stocking
  • Placebo Comparator: Placebo ECS
    Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
    Intervention: Device: Knee-length, placebo stocking

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
806
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00143598
MCT-63142, ISRCTN71334751
Yes
Dr. Susan Kahn, Sir Mortimer B. Davis - Jewish General Hospital
Sir Mortimer B. Davis - Jewish General Hospital
  • Canadian Institutes of Health Research (CIHR)
  • Sigvaris Corporation
Principal Investigator: Susan R. Kahn, M.D., M.Sc. Sir Mortimer B. Davis - Jewish General Hospital
Sir Mortimer B. Davis - Jewish General Hospital
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP