Status:
COMPLETED
The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome
Lead Sponsor:
Sir Mortimer B. Davis - Jewish General Hospital
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Sigvaris Corporation
Conditions:
Deep Venous Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ven...
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 chro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
806 Patients enrolled
Trial Details
Trial ID
NCT00143598
Start Date
June 1 2004
End Date
February 1 2012
Last Update
August 18 2014
Active Locations (25)
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1
Henry Ford Health Systerm
Detroit, Michigan, United States, 48202
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
3
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
4
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada, V8R 4R2