The 36-month Extension to Follow up Sub Study

Deep Vein Thrombosis Clinical Trial

Official title:

The Extension to Follow up Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX Trial)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01615692
• Other study ID #: MOP-102610
• Secondary ID: ISRCTN71334751
• Status: Withdrawn
• First received: June 1, 2012
• Last updated: April 16, 2018
• Start date: June 2004
• Est. completion date: June 2015

Study information

• Verified date: April 2018
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Post-Thrombotic Syndrome
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Syndrome
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
Canada	QE II Health Sciences Centre	Halifax	Nova Scotia
Canada	Hamilton Health Sciences - Chedoke Division	Hamilton	Ontario
Canada	Hamilton Health Sciences - General Hospital	Hamilton	Ontario
Canada	Hamilton Health Sciences - Henderson General Hospital	Hamilton	Ontario
Canada	Hamilton Health Sciences - McMaster University Medical Centre	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Centre Hospitalier de l'Université de Montréal - Hôpital Notre-Dame	Montreal	Quebec
Canada	Hôpital du Sacré-Coeur de Montréal	Montreal	Quebec
Canada	Hôpital Maisonneuve-Rosemont	Montreal	Quebec
Canada	Montreal General Hospital - McGill University Health Centre	Montreal	Quebec
Canada	Royal Victoria Hospital - McGill University Health Centre	Montreal	Quebec
Canada	Sir Mortimer B. Davis - Jewish General Hospital	Montreal	Quebec
Canada	St. Mary's Hospital Centre	Montreal	Quebec
Canada	The Ottawa Hospital, Civic Campus	Ottawa	Ontario
Canada	Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus	Quebec City	Quebec
Canada	Sunnybrook & Women's College Health Sciences Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	Victoria Heart Institute Foundation	Victoria	British Columbia
Canada	St. Boniface General Hospital	Winnipeg	Manitoba

Sponsors (4)

Lead Sponsor	Collaborator
Sir Mortimer B. Davis - Jewish General Hospital	Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada, Sigvaris Corporation

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of PTS and PTS severity		3 year follow up