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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

803 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-06-30

Study Completion Date

2012-02-29

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.

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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.

Conditions

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Deep Venous Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Blood Draw

SOX Subjects:

The cohort consists of original subjects from the SOX Trial who consented to participate in the sub study.

No interventions assigned to this group

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No