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

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Sigvaris Corporation
Information provided by (Responsible Party):
Dr. Susan Kahn, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT01615705
First received: June 1, 2012
Last updated: June 6, 2012
Last verified: June 2012

June 1, 2012
June 6, 2012
June 2004
September 2010   (final data collection date for primary outcome measure)
  • Markers of Inflammation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.
  • Markers of Inflammation [ Time Frame: 1-mth follow up ] [ Designated as safety issue: No ]
    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.
  • Markers of Other Thrombophilia [ Time Frame: 6-mth follow up ] [ Designated as safety issue: No ]
    Blood samples drawn at 6-mths to evaluate the relationship between D-Dimer, VIII, Lupus anticoagulant, IgG, IgM with the subsequent development of PTS.
  • Markers of Inflammation [ Time Frame: 6-month follow up ] [ Designated as safety issue: No ]
    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.
  • Markers of Other Thrombophilia [ Time Frame: 6-month follow up ] [ Designated as safety issue: No ]
    Blood samples drawn at 6-mths to evaluate the relationship between D-Dimer, VIII, Lupus anticoagulant, IgG, IgM with the subsequent development of PTS.
Same as current
Complete list of historical versions of study NCT01615705 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Biomarker Sub Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX) Trial
The Etiologic Role of Inflammation, Thrombophilia and Fibrinolysis in the Post-thrombotic Syndrome: The Bio-SOX Sub Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood samples collected and processed by centrifuge to obtain serum, peripheral blood leukocytes and platelet-poor plasma. Samples then aliquoted into 2.0ml microcentrifuge tubes for storage at -80°C until further analysis.

Non-Probability Sample

Subjects previously enrolled in the SOX Trial (ClinicalTrials.gov Identifier NCT00143598)

Deep Venous Thrombosis
Not Provided
Blood Draw

SOX Subjects:

The cohort consists of original subjects from the SOX Trial who consented to participate in the sub study.

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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
803
February 2012
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01615705
MOP-89349/NA-5629, ISRCTN71334751
Yes
Dr. Susan Kahn, Sir Mortimer B. Davis - Jewish General Hospital
Sir Mortimer B. Davis - Jewish General Hospital
  • Canadian Institutes of Health Research (CIHR)
  • Heart and Stroke Foundation of Canada
  • Sigvaris Corporation
Principal Investigator: Susan R Kahn, M.D., M.Sc. Sir Mortimer B. Davis - Jewish General Hospital
Sir Mortimer B. Davis - Jewish General Hospital
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP