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)

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.

Study Overview

• Status: Withdrawn
• Conditions: Deep Vein Thrombosis; Postphlebitic Syndrome; Post-Thrombotic Syndrome

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. At present, there is little to offer for the treatment of this condition. Prevention of PTS is the key to reducing its burden on patients and society. Elastic compression stockings (ECS) for two years following DVT could be helpful in preventing or delaying onset of PTS at three years, however data supporting this is limited.

• Study Type: Observational

Contacts and Locations

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, L8N 4A6
      • St. Joseph's Healthcare Hamilton
    • 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, 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, M5G 2C4
      • University Health Network
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook & Women's College Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Hôpital du Sacré-Coeur de Montreal
    • Montreal, Quebec, Canada, H1T 2M4
      • Hôpital Maisonneuve-Rosemont
    • Montreal, Quebec, Canada, H3T 1E2
      • Sir Mortimer B. Davis - Jewish General Hospital
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital - McGill University Health Centre
    • Montreal, Quebec, Canada, H2L 4M1
      • Centre Hospitalier de L'Universite de Montreal - Hôpital Notre-Dame
    • Montreal, Quebec, Canada, H3T 1M5
      • St. Mary's Hospital Centre
    • Montreal, Quebec, Canada, H3A 1A1
      • Royal Victoria Hospital - McGill University Health Centre
    • Quebec City, Quebec, Canada, G1J 1Z4
      • Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus

Participation Criteria

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) who did not develop PTS by 2 years follow up.

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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of PTS and PTS severity	3 year follow up

Collaborators and Investigators

• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Collaborators: Canadian Institutes of Health Research (CIHR); Heart and Stroke Foundation of Canada; Sigvaris Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: June 1, 2012
• First Submitted That Met QC Criteria: June 8, 2012
• First Posted (Estimate): June 11, 2012

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Quality of Life; Randomized Controlled Trials; Stockings, Compression; Elastic Stockings
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Embolism and Thrombosis; Peripheral Vascular Diseases; Venous Insufficiency; Phlebitis; Syndrome; Thrombosis; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome
• Other Study ID Numbers: MOP-102610; ISRCTN71334751; NCT00143598 (Registry Identifier: ISRCTN; Clinicaltrials.gov)