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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
  Purpose

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.


Condition Intervention Phase
Deep Venous Thrombosis
Device: Knee-length, graduated elastic compression stocking
Device: Knee-length, placebo stocking
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome After Symptomatic Proximal Deep Venous Thrombosis

Resource links provided by NLM:


Further study details as provided by Sir Mortimer B. Davis - Jewish General Hospital:

Primary Outcome Measures:
  • Incidence of Post-thrombotic Syndrome (PTS) [ Time Frame: During 2-year follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.



Enrollment: 806
Study Start Date: June 2004
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active ECS
Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
Device: Knee-length, graduated elastic compression stocking
Worn daily for 2 years, 30-40 mm Hg
Placebo Comparator: Placebo ECS
Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
Device: Knee-length, placebo stocking
Worn daily for two years

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143598

Locations
United States, Michigan
Henry Ford Health Systerm
Detroit, Michigan, United States, 48202
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oklahoma
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Canada, British Columbia
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada, V8R 4R2
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Nova Scotia
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8P 3B6
Hamilton Health Sciences - Chedoke Division
Hamilton, Ontario, Canada, L8N 3Z5
Hamilton Health Sciences - Henderson General Hospital
Hamilton, Ontario, Canada, L8V 1C3
Hamilton Health Sciences - McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
Hamilton Health Sciences - General Hospital
Hamilton, Ontario, Canada, L8L 2X2
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
The Ottawa Hospital, Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Centre Hospitalier Pierre-Boucher
Longueuil, Quebec, Canada, J4M 2A5
St. Mary's Hospital Center
Montreal, Quebec, Canada, H3T 1M5
Centre Hospitalier de l'Université de Montréal - Hôpital Hôtel-Dieu
Montreal, Quebec, Canada, H2W 1T8
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada, H4J 1C5
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, Canada, H4G 1A4
Royal Victoria Hospital - McGill University Health Centre
Montreal, Quebec, Canada, H3A 1A1
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Centre Hospitalier de l'Université de Montréal - Hôpital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus
Quebec City, Quebec, Canada, G1J 1Z4
Sponsors and Collaborators
Sir Mortimer B. Davis - Jewish General Hospital
Canadian Institutes of Health Research (CIHR)
Sigvaris Corporation
Investigators
Principal Investigator: Susan R. Kahn, M.D., M.Sc. Sir Mortimer B. Davis - Jewish General Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Dr. Susan Kahn, SOX Trial Principal Investigator, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT00143598     History of Changes
Other Study ID Numbers: MCT-63142, ISRCTN71334751
Study First Received: September 1, 2005
Results First Received: June 3, 2014
Last Updated: August 15, 2014
Health Authority: Canada: Health Canada

Keywords provided by Sir Mortimer B. Davis - Jewish General Hospital:
Postphlebitic Syndrome
Post-Thrombotic Syndrome
Elastic Stockings
Stockings, Compression
Randomized Controlled Trials
Quality of Life

Additional relevant MeSH terms:
Postphlebitic Syndrome
Postthrombotic Syndrome
Syndrome
Thrombosis
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Disease
Embolism and Thrombosis
Pathologic Processes
Peripheral Vascular Diseases
Phlebitis
Thromboembolism
Vascular Diseases
Venous Insufficiency

ClinicalTrials.gov processed this record on November 20, 2014