The 36-month Extension to Follow up Sub Study

Withdrawn

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

• Registration Number: NCT01615692
• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

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.

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 Timeline

• Study Start: 2004-06
• Study First Submitted: 2012-06-01
• Study First Submitted QC: 2012-06-08
• Study First Posted: 2012-06-11
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of PTS and PTS severity	3 year follow up

Trial Locations

Locations (20)

Hamilton Health Sciences - General Hospital; 🇨🇦 Hamilton, Ontario, Canada

The Ottawa Hospital, Civic Campus; 🇨🇦 Ottawa, Ontario, Canada

Sunnybrook & Women's College Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada

Royal Victoria Hospital - McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada

Centre Hospitalier de l'Université de Montréal - Hôpital Notre-Dame; 🇨🇦 Montreal, Quebec, Canada

Montreal General Hospital - McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada

Hôpital du Sacré-Coeur de Montréal; 🇨🇦 Montreal, Quebec, Canada

Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus; 🇨🇦 Quebec City, Quebec, Canada

Victoria Heart Institute Foundation; 🇨🇦 Victoria, British Columbia, Canada

Hamilton Health Sciences - Chedoke Division; 🇨🇦 Hamilton, Ontario, Canada

Hamilton Health Sciences - McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada

QE II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Hamilton Health Sciences - Henderson General Hospital; 🇨🇦 Hamilton, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Hôpital Maisonneuve-Rosemont; 🇨🇦 Montreal, Quebec, Canada

Sir Mortimer B. Davis - Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

St. Mary's Hospital Centre; 🇨🇦 Montreal, Quebec, Canada

St. Boniface General Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada