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
  Purpose

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.


Condition Phase
Deep Venous Thrombosis
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Etiologic Role of Inflammation, Thrombophilia and Fibrinolysis in the Post-thrombotic Syndrome: The Bio-SOX Sub Study

Resource links provided by NLM:


Further study details as provided by Sir Mortimer B. Davis - Jewish General Hospital:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

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.


Enrollment: 803
Study Start Date: June 2004
Study Completion Date: February 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Blood Draw

SOX Subjects:

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


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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615705

Locations
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oklahoma
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Canada, British Columbia
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada, V8R 4R2
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Nova Scotia
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Hamilton Health Sciences - Chedoke Division
Hamilton, Ontario, Canada, L8N 3Z5
Hamilton Health Sciences - McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
Hamilton Health Sciences - Henderson General Hospital
Hamilton, Ontario, Canada, L8V 1C3
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 3Z5
Hamilton Health Sciences - General Hospital
Hamilton, Ontario, Canada, L8L 2X2
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
The Ottawa Hospital, Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Centre Hospitalier Pierre-Boucher
Longueuil, Quebec, Canada, J4M 2A5
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
Montreal, Quebec, Canada, H2L 4M1
St. Mary's Hospital Center
Montreal, Quebec, Canada, H3T 1M5
Centre Hospitalier de l'Université de Montréal - Hôpital Hôtel-Dieu
Montreal, Quebec, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 4M1
Sir Mortimer B. Davis -Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada, H4J 1C5
Royal Victoria Hospital - McGill University Health Centre
Montreal, Quebec, Canada
Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus
Quebec City, Quebec, Canada, G1J 1Z4
Sponsors and Collaborators
Sir Mortimer B. Davis - Jewish General Hospital
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Sigvaris Corporation
Investigators
Principal Investigator: Susan R Kahn, M.D., M.Sc. Sir Mortimer B. Davis - Jewish General Hospital
  More Information

Publications:
Responsible Party: Dr. Susan Kahn, SOX Trial Principal Investigator, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT01615705     History of Changes
Other Study ID Numbers: MOP-89349/NA-5629, ISRCTN71334751
Study First Received: June 1, 2012
Last Updated: June 6, 2012
Health Authority: Canada: Susan R. Kahn, M.D., M.Sc, Sir Mortimer B. Davis - Jewish General Hospital

Keywords provided by Sir Mortimer B. Davis - Jewish General Hospital:
Postphlebitic Syndrome
Post-Thrombotic Syndrome
Biomarkers
Markers of Inflammation
Genetic Thrombophilia
Coagulation Activation

Additional relevant MeSH terms:
Inflammation
Postthrombotic Syndrome
Postphlebitic Syndrome
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Thrombophilia
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases
Thromboembolism
Hematologic Diseases

ClinicalTrials.gov processed this record on August 21, 2014