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

Sir Mortimer B. Davis - Jewish General Hospital803 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

803

Conditions

Deep Venous Thrombosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (25)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 6-month follow up

Data from ClinicalTrials.gov

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