Study Stopped
Sub study was not pursued as overall trial was negative
The 36-month Extension to Follow up Sub Study
The Extension to Follow up Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX Trial)
2 other identifiers
observational
N/A
1 country
20
Brief Summary
The purpose of this study is to evaluate leg health for one additional year in patients with symptomatic proximal deep venous thrombosis who did not already develop Post-Thrombotic Syndrome (PTS) during the 2 years of follow up in the SOX Trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2004
Longer than P75 for all trials
20 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
CompletedFirst Submitted
Initial submission to the registry
June 1, 2012
CompletedFirst Posted
Study publicly available on registry
June 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedApril 18, 2018
April 1, 2018
11 years
June 1, 2012
April 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of PTS and PTS severity
3 year follow up
Study Arms (1)
36-mth follow up visit
The cohort will consist of original subjects of the SOX Trial who consent to participate in the extension to follow up sub study.
Eligibility Criteria
Subjects previously enrolled in the SOX Trial (ClinicalTrials.gov Identifier NCT00143598) who did not develop PTS by 2 years follow up.
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 (20)
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 4A6, 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, Ontario, M5G 2C4, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Centre Hospitalier de l'Université de Montréal - Hôpital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
Royal Victoria Hospital - McGill University Health Centre
Montreal, Quebec, H3A 1A1, 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 Centre
Montreal, Quebec, H3T 1M5, Canada
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5, Canada
Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus
Québec, Quebec, G1J 1Z4, Canada
Related Publications (1)
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: 17711595BACKGROUND
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
June 1, 2015
Study Completion
June 1, 2015
Last Updated
April 18, 2018
Record last verified: 2018-04