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

Completed

• Conditions: Deep Venous Thrombosis

• Registration Number: NCT01615705
• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

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.

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2010-09
• Study Completion: 2012-02
• Status Verified: 2012-06
• Study First Submitted: 2012-06-01
• Study First Submitted QC: 2012-06-06
• Last Update Submitted: 2012-06-06
• Study First Posted: 2012-06-11
• Last Update Posted: 2012-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 803

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Markers of Inflammation	6-month follow up	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-month 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.

Trial Locations

Locations (25)

St. Boniface General Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Oklahoma University Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Victoria Heart Institute Foundation; 🇨🇦 Victoria, British Columbia, Canada

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

QE II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Hamilton Health Sciences - General Hospital; 🇨🇦 Hamilton, Ontario, Canada

Hamilton Health Sciences - Chedoke Division; 🇨🇦 Hamilton, Ontario, Canada

Hamilton Health Sciences - McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada

Hamilton Health Sciences - Henderson General Hospital; 🇨🇦 Hamilton, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

The Ottawa Hospital, Civic Campus; 🇨🇦 Ottawa, Ontario, Canada

Sunnybrook & Women's College Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Hôpital Maisonneuve-Rosemont; 🇨🇦 Montreal, Quebec, Canada

Hôpital du Sacré-Coeur de Montréal; 🇨🇦 Montreal, Quebec, Canada

University Health Network - Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal - Hôpital Hôtel-Dieu; 🇨🇦 Montreal, Quebec, Canada

Royal Victoria Hospital - McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada

Centre Hospitalier Pierre-Boucher; 🇨🇦 Longueuil, Quebec, Canada

Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus; 🇨🇦 Quebec City, Quebec, Canada

Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame; 🇨🇦 Montreal, Quebec, Canada

Montreal General Hospital - McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada

Sir Mortimer B. Davis -Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

St. Mary's Hospital Center; 🇨🇦 Montreal, Quebec, Canada

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada