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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01615705

Acronym

Bio-SOX

Enrollment

803

Registered

2012-06-11

Start date

2004-06-30

Completion date

2012-02-29

Last updated

2012-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Venous Thrombosis

Keywords

Postphlebitic Syndrome, Post-Thrombotic Syndrome, Biomarkers, Markers of Inflammation, Genetic Thrombophilia, Coagulation Activation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Markers of Inflammation	Baseline	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-mth 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.

Countries

Canada, United States

Outcome results