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

June 6, 2012 updated by: Dr. Susan Kahn, Sir Mortimer B. Davis - Jewish General Hospital

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

803

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 4R2
        • Victoria Heart Institute Foundation
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • QE II Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences - General Hospital
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Hamilton Health Sciences - Chedoke Division
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Hamilton Health Sciences - McMaster University Medical Centre
      • Hamilton, Ontario, Canada, L8N 3Z5
        • St. Joseph's Healthcare Hamilton
      • Hamilton, Ontario, Canada, L8V 1C3
        • Hamilton Health Sciences - Henderson General Hospital
      • London, Ontario, Canada, N6A 4G5
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1Y 4E9
        • The Ottawa Hospital, Civic Campus
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook & Women's College Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network - Toronto General Hospital
    • Quebec
      • Longueuil, Quebec, Canada, J4M 2A5
        • Centre Hospitalier Pierre-Boucher
      • Montreal, Quebec, Canada, H4J 1C5
        • Hôpital du Sacré-Coeur de Montreal
      • Montreal, Quebec, Canada, H3T 1M5
        • St. Mary's Hospital Center
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital - McGill University Health Centre
      • Montreal, Quebec, Canada, H1T 4M1
        • Hôpital Maisonneuve-Rosemont
      • Montreal, Quebec, Canada, H2L 4M1
        • Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
      • Montreal, Quebec, Canada, H3T 1E2
        • Sir Mortimer B. Davis -Jewish General Hospital
      • Montreal, Quebec, Canada
        • Centre Hospitalier de l'Université de Montréal - Hôpital Hôtel-Dieu
      • Montreal, Quebec, Canada
        • Royal Victoria Hospital - McGill University Health Centre
      • Quebec City, Quebec, Canada, G1J 1Z4
        • Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus
  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects previously enrolled in the SOX Trial (ClinicalTrials.gov Identifier NCT00143598)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Blood Draw

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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Markers of Inflammation
Time Frame: 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.
Baseline
Markers of Inflammation
Time Frame: 1-mth 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.
1-mth follow up
Markers of Other Thrombophilia
Time Frame: 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.
6-mth follow up
Markers of Inflammation
Time Frame: 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.
6-month follow up
Markers of Other Thrombophilia
Time Frame: 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.
6-month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Collaborators

Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Sigvaris Corporation

Investigators

  • Principal Investigator: Susan R Kahn, M.D., M.Sc., Sir Mortimer B. Davis - Jewish General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

June 1, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (Estimate)

June 11, 2012

Study Record Updates

Last Update Posted (Estimate)

June 11, 2012

Last Update Submitted That Met QC Criteria

June 6, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOP-89349/NA-5629
  • ISRCTN71334751 (REGISTRY: ISRCTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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