The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome
This study has been completed.
Sponsor:
Sir Mortimer B. Davis - Jewish General Hospital
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: June 1, 2012
Last verified: June 2012
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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 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 ]
| Enrollment: | 803 |
| 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 |
|---|---|
|
1
Knee-length, graduated elastic compression stocking
|
Device: Knee-length, graduated elastic compression stocking
Worn daily for 2 years, 30-40 mm Hg
|
|
Placebo Comparator: 2
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
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 - McMaster University Medical Centre | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Hamilton Health Sciences - Chedoke Division | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Hamilton Health Sciences - General Hospital | |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| Hamilton Health Sciences - Henderson General Hospital | |
| Hamilton, Ontario, Canada, L8V 1C3 | |
| London Health Sciences Centre | |
| London, Ontario, Canada, N6A 4G5 | |
| The Ottawa Hospital, Civic Campus | |
| Ottawa, Ontario, Canada, K1Y 4E9 | |
| Sunnybrook & Women's College Health Sciences Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| University Health Network - Toronto General Hospital | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Canada, Quebec | |
| Centre Hospitalier Pierre-Boucher | |
| Longueuil, Quebec, Canada, J4M 2A5 | |
| Sir Mortimer B. Davis - Jewish General Hospital | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| 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 Maisonneuve-Rosemont | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Centre Hospitalier de l'Université de Montréal - Hôpital Notre-Dame | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Montreal General Hospital - McGill University Health Centre | |
| Montreal, Quebec, Canada, H4G 1A4 | |
| Hôpital du Sacré-Coeur de Montréal | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| Royal Victoria Hospital - McGill University Health Centre | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| 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
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 |
| Last Updated: | June 1, 2012 |
| 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:
|
Postthrombotic Syndrome Postphlebitic Syndrome Thrombosis Venous Thrombosis Venous Thromboembolism Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Venous Insufficiency Phlebitis Peripheral Vascular Diseases Thromboembolism |
ClinicalTrials.gov processed this record on May 23, 2013