Deep Venous ThrombosisBio-SOXNCT01615705
Biomarker Sub Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX) Trial
An observational study of Deep Venous Thrombosis, run by Sir Mortimer B. Davis - Jewish General Hospital at 25 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Venous Thrombosis
- How many people
- 803 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Jun 2004to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects previously enrolled in the SOX Trial (ClinicalTrials.gov Identifier NCT00143598)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
Canada22 sites
QE II Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7
Hamilton Health Sciences - General Hospital
Hamilton, Ontario, L8L 2X2
Hamilton Health Sciences - Chedoke Division
Hamilton, Ontario, L8N 3Z5
Hamilton Health Sciences - McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 3Z5
Hamilton Health Sciences - Henderson General Hospital
Hamilton, Ontario, L8V 1C3
London Health Sciences Centre
London, Ontario, N6A 4G5
Centre Hospitalier Pierre-Boucher
Longueuil, Quebec, J4M 2A5
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 4M1
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
Montreal, Quebec, H2L 4M1
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, H3G 1A4
Sir Mortimer B. Davis -Jewish General Hospital
Montreal, Quebec, H3T 1E2
St. Mary's Hospital Center
Montreal, Quebec, H3T 1M5
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5
Centre Hospitalier de l'Université de Montréal - Hôpital Hôtel-Dieu
Montreal, Quebec
Royal Victoria Hospital - McGill University Health Centre
Montreal, Quebec
The Ottawa Hospital, Civic Campus
Ottawa, Ontario, K1Y 4E9
Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus
Québec, Quebec, G1J 1Z4
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, M4N 3M5
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2C4
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 4R2
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
United States3 sites
Henry Ford Health System
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: 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.
Read the 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.
- Conditions
- Deep Venous Thrombosis
- Keywords
- Postphlebitic Syndrome, Post-Thrombotic Syndrome, Biomarkers, Markers of Inflammation, Genetic Thrombophilia, Coagulation Activation
- Medical subject headings
- Venous Thrombosis, Postphlebitic Syndrome, Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Blood Draw | SOX Subjects: The cohort consists of original subjects from the SOX Trial who consented to participate in the sub study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: 1-mth follow up
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.
Measured: 6-mth follow up
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.
Measured: 6-month follow up
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.
Measured: 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startJun 2004
- Primary completionSep 2010
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Deep Venous ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada, Sigvaris Corporation
- Responsible party
- Principal investigator, Dr. Susan Kahn, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Susan R Kahn, M.D., M.Sc., Principal investigator, Sir Mortimer B. Davis - Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615705
- Sponsor's protocol ID
- MOP-89349/NA-5629
- Other IDs
- ISRCTN71334751
- Acronym
- Bio-SOX
- Status last verified
- Jun 2012
- First submitted
- 1 Jun 2012
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. doi: 10.1186/1471-2261-7-21.
PubMed 17711595Rabinovich A, Cohen JM, Cushman M, Kahn SR; BioSOX Investigators. Association between inflammation biomarkers, anatomic extent of deep venous thrombosis, and venous symptoms after deep venous thrombosis. J Vasc Surg Venous Lymphat Disord. 2015 Oct;3(4):347-353.e1. doi: 10.1016/j.jvsv.2015.04.005. Epub 2015 Aug 1.
PubMed 26992609
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Etiologic Role of Inflammation, Thrombophilia and Fibrinolysis in the Post-thrombotic Syndrome: The Bio-SOX Sub Study
- ClinicalTrials.gov ID
- NCT01615705
- Acronym / sponsor ID
- Bio-SOX / MOP-89349/NA-5629
- Conditions
- Deep Venous Thrombosis
- Keywords
- Postphlebitic Syndrome, Post-Thrombotic Syndrome, Biomarkers, Markers of Inflammation, Genetic Thrombophilia, Coagulation Activation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada, Sigvaris Corporation
- Study start
- Jun 2004
- Primary completion
- Sep 2010 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 11 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood Draw | – | –SOX Subjects: The cohort consists of original subjects from the SOX Trial who consented to participate in the sub study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects previously enrolled in the SOX Trial (ClinicalTrials.gov Identifier NCT00143598)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Markers of Inflammation
Time frame: Baseline
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
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
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
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
Blood samples drawn at 6-mths to evaluate the relationship between D-Dimer, VIII, Lupus anticoagulant, IgG, IgM with the subsequent development of PTS.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
- Background: PubMed 17711595Kahn 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. doi: 10.1186/1471-2261-7-21.
- Derived from this study: PubMed 26992609Rabinovich A, Cohen JM, Cushman M, Kahn SR; BioSOX Investigators. Association between inflammation biomarkers, anatomic extent of deep venous thrombosis, and venous symptoms after deep venous thrombosis. J Vasc Surg Venous Lymphat Disord. 2015 Oct;3(4):347-353.e1. doi: 10.1016/j.jvsv.2015.04.005. Epub 2015 Aug 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan R Kahn, M.D., M.Sc. principal investigator
Sir Mortimer B. Davis - Jewish General Hospital
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Venous Thrombosis, run by Sir Mortimer B. Davis - Jewish General Hospital at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Markers of Inflammation (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01615705, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2012.