Condition(s) treated: Deep Venous Thrombosis

Intervention: Knee-length, graduated elastic compression stocking (30-40 mm Hg) worn daily for 2 years. (Device); Knee-length, placebo stocking worn daily for two years. (Device)

Phase: Phase 3

Enrollment status: Recruiting

Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Principal investigator(s) or official(s):
Susan R. Kahn, M.D., M.Sc., Principal Investigator, Affiliation: Sir Mortimer B. Davis - Jewish General Hospital

Overall contact:
Susan R. Kahn, M.D., M.Sc., Phone: 514-340-8222, Ext: 4667, Email: susan.kahn@mcgill.ca

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.

Official title: The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome After Symptomatic Proximal Deep Venous Thrombosis

Study design: Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Incidence of PTS during 2-year follow up.

Secondary outcome:
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.

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.

Minimum eligible age: 18 Years. Eligible gender(s): Both.

Criteria:

Inclusion Criteria:

- Consecutive patients with a first, symptomatic, objectively confirmed proximal DVT

diagnosed within the last 10 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.

Susan R. Kahn, M.D., M.Sc., Phone: 514-340-8222, Ext: 4667, Email: susan.kahn@mcgill.ca

Victoria Heart Institute Foundation, Victoria, British Columbia V8R 4R2, Canada; Recruiting
Reginald E. Smith, Pharm.D., Phone: 250-595-1884
Reginald E. Smith, Pharm.D., Principal Investigator

St. Paul's Hospital, Vancouver, British Columbia V6Z 1Y6, Canada; Withdrawn

St. Boniface General Hospital, Winnipeg, Manitoba R2H 2A6, Canada; Recruiting
Turnly Wong, M.D., Phone: 204-237-2545
Turnly Wong, M.D., Principal Investigator

Henry Ford Health Systerm, Detroit, Michigan 48202, United States; Recruiting
Scott Kaatz, DO, Email: SKAATZ1@hfhs.org
Scott Kaatz, DO, MSc, Principal Investigator

QE II Health Sciences Centre, Halifax, Nova Scotia B3H 2Y9, Canada; Recruiting
David R. Anderson, M.D., Phone: 902-473-8562
David R. Anderson, M.D., Principal Investigator

Oklahoma University Health Sciences Center, Oklahoma City, Oklahoma 73104, United States; Recruiting
Suman Rathbun, MD, Phone: 405-271-4742
Suman Rathbun, M.D., Principal Investigator

The Ottawa Hospital, Civic Campus, Ottawa, Ontario K1Y 4E9, Canada; Recruiting
Philip S. Wells, Phone: 613-761-4127, Ext: 3
Philip S. Wells, M.D., M.Sc., Principal Investigator

London Health Sciences Centre, London, Ontario N6A 4G5, Canada; Recruiting
Michael J. Kovacs, M.D., Phone: 519-685-8500, Ext: 52254
Michael J. Kovacs, M.D., Principal Investigator

Sunnybrook & Women's College Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada; Recruiting
Rita Selby, M.D., Phone: 416-480-5105
Rita Selby, M.D., Principal Investigator

Hamilton Health Sciences - McMaster University Medical Centre, Hamilton, Ontario L8N 3Z5, Canada; Recruiting
Jeffrey S. Ginsberg, M.D., Phone: 905-521-2100, Ext: 76973
Jeffrey S. Ginsberg, M.D., Principal Investigator

Hamilton Health Sciences - Henderson General Hospital, Hamilton, Ontario L8V 1C3, Canada; Recruiting
Clive Kearon, M.D., Ph.D., Phone: 905-383-2251
Clive Kearon, M.D., Ph.D., Principal Investigator

Hamilton Health Sciences - General Hospital, Hamilton, Ontario L8L 2X2, Canada; Recruiting
Sam Schulman, M.D., Ph.D., Phone: 905-528-9946
Sam Schulman, M.D., Ph.D., Principal Investigator

St. Joseph's Healthcare Hamilton, Hamilton, Ontario L8P 3B6, Canada; Recruiting
Rajendar Hanmiah, M.D., Phone: 905-521-6053
Rajendar Hanmiah, M.D., Principal Investigator

Hamilton Health Sciences - Chedoke Division, Hamilton, Ontario L8N 3Z5, Canada; Recruiting
Jeffrey S. Ginsberg, M.D., Phone: 905-521-2100, Ext: 76973
Jeffrey S. Ginsberg, M.D., Principal Investigator

University Health Network - Toronto General Hospital, Toronto, Ontario M5G 2C4, Canada; Recruiting
Erik L. Yeo, MD, Phone: 416-340-4069
Erik L. Yeo, M.D., Principal Investigator

Sir Mortimer B. Davis - Jewish General Hospital, Montreal, Quebec H3T 1E2, Canada; Recruiting
Susan R. Kahn, M.D., M.Sc., Phone: 514-340-8222, Ext: 4667
Susan R. Kahn, M.D., M.Sc., Principal Investigator

Montreal General Hospital - McGill University Health Centre, Montreal, Quebec H4G 1A4, Canada; Recruiting
Susan Solymoss, M.D., Phone: 514-934-8007
Susan Solymoss, M.D., Principal Investigator

St. Mary's Hospital Center, Montreal, Quebec H3T 1M5, Canada; Recruiting
Susan Solymoss, M.D., Phone: 514-345-3511
Susan Solymoss, M.D., Principal Investigator

Centre Hospitalier de l'Université de Montréal - Hôpital Notre-Dame, Montreal, Quebec H2L 4M1, Canada; Recruiting
Marie-José F. Miron, M.D., M.Sc., Phone: 514-890-8000, Ext: 27049
Marie-José F. Miron, M.D., M.Sc., Principal Investigator

Hôpital Maisonneuve-Rosemont, Montreal, Quebec H1T 2M4, Canada; Recruiting
Jeannine Kassis, M.D., Phone: 514-252-3404
Jeannine Kassis, M.D., Principal Investigator

Centre Hospitalier Pierre-Boucher, Longueuil, Quebec J4M 2A5, Canada; Terminated

Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus, Quebec City, Quebec G1J 1Z4, Canada; Recruiting
Christine Demers, M.D., Phone: 418-649-5726
Christine Demers, M.D., Principal Investigator

Hôpital du Sacré-Coeur de Montréal, Montreal, Quebec H4J 1C5, Canada; Recruiting
Isabelle Chagnon, M.D., Phone: 514-338-2050
Isabelle Chagnon, M.D., Principal Investigator

Royal Victoria Hospital - McGill University Health Centre, Montreal, Quebec H3A 1A1, Canada; Recruiting
Lucie Opatrny, M.D., Phone: 514-843-1515
Lucie Opatrny, M.D., Principal Investigator

Centre Hospitalier de l'Université de Montréal - Hôpital Hôtel-Dieu, Montreal, Quebec H2W 1T8, Canada; Terminated

Start date: June 2004
Last updated: May 8, 2008

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