Biomarker Sub Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX) Trial
Biomarker Sub Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX) Trial
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.
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.
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