Biomarker Sub Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX) Trial
Bio-SOX
The Etiologic Role of Inflammation, Thrombophilia and Fibrinolysis in the Post-thrombotic Syndrome: The Bio-SOX Sub Study
2 other identifiers
observational
803
2 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2004
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 1, 2012
CompletedFirst Posted
Study publicly available on registry
June 11, 2012
CompletedJune 11, 2012
June 1, 2012
6.3 years
June 1, 2012
June 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
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.
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.
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.
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.
6-month follow up
Study Arms (1)
Blood Draw
SOX Subjects: The cohort consists of original subjects from the SOX Trial who consented to participate in the sub study.
Eligibility Criteria
Subjects previously enrolled in the SOX Trial (ClinicalTrials.gov Identifier NCT00143598)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sir Mortimer B. Davis - Jewish General Hospitallead
- Canadian Institutes of Health Research (CIHR)collaborator
- Heart and Stroke Foundation of Canadacollaborator
- Sigvaris Corporationcollaborator
Study Sites (25)
Henry Ford Health System
Detroit, Michigan, 48202, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 4R2, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
QE II Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Hamilton Health Sciences - General Hospital
Hamilton, Ontario, L8L 2X2, Canada
Hamilton Health Sciences - Chedoke Division
Hamilton, Ontario, L8N 3Z5, Canada
Hamilton Health Sciences - McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 3Z5, Canada
Hamilton Health Sciences - Henderson General Hospital
Hamilton, Ontario, L8V 1C3, Canada
London Health Sciences Centre
London, Ontario, N6A 4G5, Canada
The Ottawa Hospital, Civic Campus
Ottawa, Ontario, K1Y 4E9, Canada
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Centre Hospitalier Pierre-Boucher
Longueuil, Quebec, J4M 2A5, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 4M1, Canada
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
Montreal, Quebec, H2L 4M1, Canada
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, H3G 1A4, Canada
Sir Mortimer B. Davis -Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
St. Mary's Hospital Center
Montreal, Quebec, H3T 1M5, Canada
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5, 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 affilié universitaire de Québec, Hôpital de l'Enfant-Jésus
Québec, Quebec, G1J 1Z4, Canada
Related Publications (2)
Kahn SR, Shbaklo H, Shapiro S, Wells PS, Kovacs MJ, Rodger MA, Anderson DR, Ginsberg JS, Johri M, Tagalakis V; SOX Trial Investigators. Effectiveness of compression stockings to prevent the post-thrombotic syndrome (the SOX Trial and Bio-SOX biomarker substudy): a randomized controlled trial. BMC Cardiovasc Disord. 2007 Jul 24;7:21. doi: 10.1186/1471-2261-7-21.
PMID: 17711595BACKGROUNDRabinovich A, Cohen JM, Cushman M, Kahn SR; BioSOX Investigators. Association between inflammation biomarkers, anatomic extent of deep venous thrombosis, and venous symptoms after deep venous thrombosis. J Vasc Surg Venous Lymphat Disord. 2015 Oct;3(4):347-353.e1. doi: 10.1016/j.jvsv.2015.04.005. Epub 2015 Aug 1.
PMID: 26992609DERIVED
Biospecimen
Blood samples collected and processed by centrifuge to obtain serum, peripheral blood leukocytes and platelet-poor plasma. Samples then aliquoted into 2.0ml microcentrifuge tubes for storage at -80°C until further analysis.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan R Kahn, M.D., M.Sc.
Sir Mortimer B. Davis - Jewish General Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- SOX Trial Principal Investigator
Study Record Dates
First Submitted
June 1, 2012
First Posted
June 11, 2012
Study Start
June 1, 2004
Primary Completion
September 1, 2010
Study Completion
February 1, 2012
Last Updated
June 11, 2012
Record last verified: 2012-06