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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Etiologic Role of Inflammation, Thrombophilia and Fibrinolysis in the Post-thrombotic Syndrome: The Bio-SOX Sub Study

Conditions
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Deep Venous Thrombosis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Blood Draw<br>SOX Subjects: The cohort consists of original subjects from the SOX Trial who consented to participate in the sub study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Markers of Inflammation | 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. | Baseline | 
| Markers of Inflammation | 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. | 1-mth follow up | 
| Markers of Other Thrombophilia | Blood samples drawn at 6-mths to evaluate the relationship between D-Dimer, VIII, Lupus anticoagulant, IgG, IgM with the subsequent development of PTS. | 6-mth follow up | 
| Markers of Inflammation | 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. | 6-month follow up | 
| Markers of Other Thrombophilia | Blood samples drawn at 6-mths to evaluate the relationship between D-Dimer, VIII, Lupus anticoagulant, IgG, IgM with the subsequent development of PTS. | 6-month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postphlebitic Syndrome, Post-Thrombotic Syndrome, Biomarkers, Markers of Inflammation, Genetic Thrombophilia, Coagulation Activation