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

Sponsor:	Sir Mortimer B. Davis - Jewish General Hospital
Collaborators:	Canadian Institutes of Health Research (CIHR) Sigvaris Corporation
Information provided by:	Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier:	NCT00143598

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome After Symptomatic Proximal Deep Venous Thrombosis

Resource links provided by NLM:

MedlinePlus related topics: Deep Vein Thrombosis

U.S. FDA Resources

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

Primary Outcome Measures:

Incidence of 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: During 2-year follow up ] [ Designated as safety issue: No ]
Incidence of objectively confirmed recurrent VTE, death from VTE and major bleeding [ Time Frame: During 2-year follow up ] [ Designated as safety issue: No ]
C-reactive protein [ Time Frame: At baseline and 30 days ] [ Designated as safety issue: Yes ]
Quality of life [ Time Frame: During 2-year follow up ] [ Designated as safety issue: No ]
Cost-effectiveness [ Time Frame: During 2-year follow up ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	June 2004
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Knee-length, graduated elastic compression stocking	Device: Knee-length, graduated elastic compression stocking Worn daily for 2 years, 30-40 mm Hg
2: Placebo Comparator Knee-length, placebo stocking	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

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

Contacts

Contact: Susan R. Kahn, M.D., M.Sc.

514-340-8222 ext 4667

susan.kahn@mcgill.ca

Locations

United States, Michigan
Henry Ford Health Systerm	Recruiting
Detroit, Michigan, United States, 48202
Contact: Scott Kaatz, DO SKAATZ1@hfhs.org
Principal Investigator: Scott Kaatz, DO, MSc
United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Thomas Ortel, M.D., Ph.D thomas.ortel@duke.edu
Principal Investigator: Thomas Ortel, M.D., Ph.D.
United States, Oklahoma
Oklahoma University Health Sciences Center	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Suman Rathbun, MD 405-271-4742
Principal Investigator: Suman Rathbun, M.D.
Canada, British Columbia
Victoria Heart Institute Foundation	Recruiting
Victoria, British Columbia, Canada, V8R 4R2
Contact: Reginald E. Smith, Pharm.D. 250-595-1884
Principal Investigator: Reginald E. Smith, Pharm.D.
St. Paul's Hospital	Withdrawn
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
St. Boniface General Hospital	Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Turnly Wong, M.D. 204-237-2545
Principal Investigator: Turnly Wong, M.D.
Canada, Nova Scotia
QE II Health Sciences Centre	Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: David R. Anderson, M.D. 902-473-8562
Principal Investigator: David R. Anderson, M.D.
Canada, Ontario
The Ottawa Hospital, Civic Campus	Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Philip S. Wells 613-761-4127 ext 3
Principal Investigator: Philip S. Wells, M.D., M.Sc.
London Health Sciences Centre	Recruiting
London, Ontario, Canada, N6A 4G5
Contact: Michael J. Kovacs, M.D. 519-685-8500 ext 52254
Principal Investigator: Michael J. Kovacs, M.D.
Sunnybrook & Women's College Health Sciences Centre	Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Rita Selby, M.D. 416-480-5105
Principal Investigator: Rita Selby, M.D.
Hamilton Health Sciences - General Hospital	Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Sam Schulman, M.D., Ph.D. 905-528-9946
Principal Investigator: Sam Schulman, M.D., Ph.D.
Hamilton Health Sciences - Henderson General Hospital	Recruiting
Hamilton, Ontario, Canada, L8V 1C3
Contact: Clive Kearon, M.D., Ph.D. 905-383-2251
Principal Investigator: Clive Kearon, M.D., Ph.D.
Hamilton Health Sciences - McMaster University Medical Centre	Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Jeffrey S. Ginsberg, M.D. 905-521-2100 ext 76973
Principal Investigator: Jeffrey S. Ginsberg, M.D.
St. Joseph's Healthcare Hamilton	Recruiting
Hamilton, Ontario, Canada, L8P 3B6
Contact: Rajendar Hanmiah, M.D. 905-521-6053
Principal Investigator: Rajendar Hanmiah, M.D.
Hamilton Health Sciences - Chedoke Division	Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Jeffrey S. Ginsberg, M.D. 905-521-2100 ext 76973
Principal Investigator: Jeffrey S. Ginsberg, M.D.
University Health Network - Toronto General Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Erik L. Yeo, MD 416-340-4069
Principal Investigator: Erik L. Yeo, M.D.
Canada, Quebec
Sir Mortimer B. Davis - Jewish General Hospital	Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Susan R. Kahn, M.D., M.Sc. 514-340-8222 ext 4667
Principal Investigator: Susan R. Kahn, M.D., M.Sc.
Montreal General Hospital - McGill University Health Centre	Recruiting
Montreal, Quebec, Canada, H4G 1A4
Contact: Susan Solymoss, M.D. 514-934-8007
Principal Investigator: Susan Solymoss, M.D.
St. Mary's Hospital Center	Recruiting
Montreal, Quebec, Canada, H3T 1M5
Contact: Susan Solymoss, M.D. 514-345-3511
Principal Investigator: Susan Solymoss, M.D.
Centre Hospitalier de l'Université de Montréal - Hôpital Notre-Dame	Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Marie-José F. Miron, M.D., M.Sc. 514-890-8000 ext 27049
Principal Investigator: Marie-José F. Miron, M.D., M.Sc.
Centre Hospitalier de l'Université de Montréal - Hôpital Hôtel-Dieu	Terminated
Montreal, Quebec, Canada, H2W 1T8
Centre Hospitalier Pierre-Boucher	Terminated
Longueuil, Quebec, Canada, J4M 2A5
Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus	Recruiting
Quebec City, Quebec, Canada, G1J 1Z4
Contact: Christine Demers, M.D. 418-649-5726
Principal Investigator: Christine Demers, M.D.
Hôpital du Sacré-Coeur de Montréal	Recruiting
Montreal, Quebec, Canada, H4J 1C5
Contact: Isabelle Chagnon, M.D. 514-338-2050
Principal Investigator: Isabelle Chagnon, M.D.
Royal Victoria Hospital - McGill University Health Centre	Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Lucie Opatrny, M.D. 514-843-1515
Principal Investigator: Lucie Opatrny, M.D.
Hôpital Maisonneuve-Rosemont	Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Jeannine Kassis, M.D. 514-252-3404
Principal Investigator: Jeannine Kassis, M.D.

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

No publications provided by Sir Mortimer B. Davis - Jewish General Hospital

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Sir Mortimer B. Davis - Jewish General Hospital ( Susan R. Kahn, M.D., M.Sc )
Study ID Numbers:	MCT-63142, ISRCTN71334751
Study First Received:	September 1, 2005
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00143598 History of Changes
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:

Peripheral Vascular Diseases
Disease
Vascular Diseases
Postthrombotic Syndrome
Thrombosis
Embolism and Thrombosis
Pathologic Processes

Syndrome
Venous Insufficiency
Phlebitis
Venous Thrombosis
Cardiovascular Diseases
Postphlebitic Syndrome

ClinicalTrials.gov processed this record on November 25, 2009