Clinical trial NCT01615705: Biomarker Sub Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX) Trial
Official title: The Etiologic Role of Inflammation, Thrombophilia and Fibrinolysis in the Post-thrombotic Syndrome: The Bio-SOX Sub Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Venous Thrombosis
Keywords: Postphlebitic Syndrome
Post-Thrombotic Syndrome
Biomarkers
Markers of Inflammation
Genetic Thrombophilia
Coagulation Activation
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Heart and Stroke Foundation of Canada
name: Sigvaris Corporation
First posted: 2012-06-11
Enrollment: 803
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects previously enrolled in the SOX Trial (ClinicalTrials.gov Identifier NCT00143598)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Markers of Inflammation
timeFrame: Baseline
measure: Markers of Inflammation
timeFrame: 1-mth follow up
measure: Markers of Other Thrombophilia
timeFrame: 6-mth follow up
measure: Markers of Inflammation
timeFrame: 6-month follow up
measure: Markers of Other Thrombophilia
timeFrame: 6-month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma University Health Sciences Center
state: Oklahoma
city: Victoria
country: Canada
facility: Victoria Heart Institute Foundation
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Halifax
country: Canada
facility: QE II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Chedoke Division
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - McMaster University Medical Centre
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Henderson General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital, Civic Campus
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook & Women's College Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
state: Ontario
city: Longueuil
country: Canada
facility: Centre Hospitalier Pierre-Boucher
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital - McGill University Health Centre
state: Quebec
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis -Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: St. Mary's Hospital Center
state: Quebec
city: Montreal
country: Canada
facility: Hôpital du Sacré-Coeur de Montréal
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal - Hôpital Hôtel-Dieu
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital - McGill University Health Centre
state: Quebec
city: Quebec City
country: Canada
facility: Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus
state: Quebec
Study officials:
affiliation: Sir Mortimer B. Davis - Jewish General Hospital
name: Susan R Kahn, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Rabinovich 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.