Biomarker Sub Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX) Trial
- Conditions
- Deep Venous Thrombosis
- Registration Number
- NCT01615705
- Lead Sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Brief Summary
The purpose of this study is to evaluate whether biomarkers of inflammation, genetic thrombophilia and coagulation activation influence Post-Thrombotic Syndrome development in patients with symptomatic proximal deep venous thrombosis.
- 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. Poor understanding of the pathophysiology and predictors of PTS has hampered progress in its prevention and treatment. Biomarkers reflective of inflammation, genetic thrombophilia and coagulation activation may be of value in predicting PTS development in patients with DVT; they may also provide insight into understanding the underlying mechanisms of PTS, which could result in the development and testing of novel therapies to prevent and treat PTS.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 803
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Markers of Inflammation 6-month follow up Blood samples drawn at baseline, 1 and 6-mths to evaluate the relationship between CRP, ICAM, IL-6, IL-10 with the subsequent development of PTS.
Markers of Other Thrombophilia 6-month follow up Blood samples drawn at 6-mths to evaluate the relationship between D-Dimer, VIII, Lupus anticoagulant, IgG, IgM with the subsequent development of PTS.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Oklahoma University Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Victoria Heart Institute Foundation
🇨🇦Victoria, British Columbia, Canada
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
QE II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
Hamilton Health Sciences - General Hospital
🇨🇦Hamilton, Ontario, Canada
Hamilton Health Sciences - Chedoke Division
🇨🇦Hamilton, Ontario, Canada
Hamilton Health Sciences - McMaster University Medical Centre
🇨🇦Hamilton, Ontario, Canada
Hamilton Health Sciences - Henderson General Hospital
🇨🇦Hamilton, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
The Ottawa Hospital, Civic Campus
🇨🇦Ottawa, Ontario, Canada
Sunnybrook & Women's College Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Hôpital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
Hôpital du Sacré-Coeur de Montréal
🇨🇦Montreal, Quebec, Canada
University Health Network - Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal - Hôpital Hôtel-Dieu
🇨🇦Montreal, Quebec, Canada
Royal Victoria Hospital - McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Pierre-Boucher
🇨🇦Longueuil, Quebec, Canada
Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus
🇨🇦Quebec City, Quebec, Canada
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
🇨🇦Montreal, Quebec, Canada
Montreal General Hospital - McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Sir Mortimer B. Davis -Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
St. Mary's Hospital Center
🇨🇦Montreal, Quebec, Canada
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada