Biomarker Sub Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX) Trial

Deep Venous Thrombosis Clinical Trial

— Bio-SOX  

Official title:

The Etiologic Role of Inflammation, Thrombophilia and Fibrinolysis in the Post-thrombotic Syndrome: The Bio-SOX Sub Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615705
• Other study ID #: MOP-89349/NA-5629
• Secondary ID: ISRCTN71334751
• Status: Completed
• Phase: Phase 3
• First received: June 1, 2012
• Last updated: June 6, 2012
• Start date: June 2004
• Est. completion date: February 2012

Study information

• Verified date: June 2012
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Susan R. Kahn, M.D., M.Sc, Sir Mortimer B. Davis - Jewish General Hospital
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 803
• Est. completion date: February 2012
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• 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 Pierre-Boucher	Longueuil	Quebec
Canada	Centre Hospitalier de l'Université de Montréal - Hôpital Hôtel-Dieu	Montreal	Quebec
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 Center	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 General Hospital	Toronto	Ontario
Canada	Victoria Heart Institute Foundation	Victoria	British Columbia
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Oklahoma University Health Sciences Center	Oklahoma City	Oklahoma

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

Countries where clinical trial is conducted

United States,  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	Markers of Inflammation	Blood samples drawn at baseline, 1 and 6-mths to evaluate the relationship between CRP, ICAM, IL-6, IL-10 with the subsequent development of PTS.	Baseline	No
Primary	Markers of Inflammation	Blood samples drawn at baseline, 1 and 6-mths to evaluate the relationship between CRP, ICAM, IL-6, IL-10 with the subsequent development of PTS.	1-mth follow up	No
Primary	Markers of Other Thrombophilia	Blood samples drawn at 6-mths to evaluate the relationship between D-Dimer, VIII, Lupus anticoagulant, IgG, IgM with the subsequent development of PTS.	6-mth follow up	No
Primary	Markers of Inflammation	Blood samples drawn at baseline, 1 and 6-mths to evaluate the relationship between CRP, ICAM, IL-6, IL-10 with the subsequent development of PTS.	6-month follow up	No
Primary	Markers of Other Thrombophilia	Blood samples drawn at 6-mths to evaluate the relationship between D-Dimer, VIII, Lupus anticoagulant, IgG, IgM with the subsequent development of PTS.	6-month follow up	No