Postphlebitic SyndromeNCT01615692
The 36-month Extension to Follow up Sub Study
An observational study of Postphlebitic Syndrome and Post-Thrombotic Syndrome, run by Sir Mortimer B. Davis - Jewish General Hospital at 20 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postphlebitic Syndrome, Post-Thrombotic Syndrome, Deep Vein Thrombosis
- How many people
- 0 participants
- Where
- 20 sitesCanada
- Study dates
- Jun 2004to Jun 2015
- 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 did not develop PTS by 2 years follow up.
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
20 sites in 1 country.
20 sites in 1 country
Canada20 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 4A6
Hamilton Health Sciences - Henderson General Hospital
Hamilton, Ontario, L8V 1C3
London Health Sciences Centre
London, Ontario, N6A 4G5
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Centre Hospitalier de l'Université de Montréal - Hôpital Notre-Dame
Montreal, Quebec, H2L 4M1
Royal Victoria Hospital - McGill University Health Centre
Montreal, Quebec, H3A 1A1
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 Centre
Montreal, Quebec, H3T 1M5
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5
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, Ontario, M5G 2C4
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 4R2
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: The Extension to Follow up Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX Trial)
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.
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. 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.
- Keywords
- Elastic Stockings, Stockings, Compression, Randomized Controlled Trials, Quality of Life
- Medical subject headings
- Postphlebitic Syndrome, Postthrombotic Syndrome, Venous Thrombosis
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 |
|---|---|---|
| 36-mth follow up visit | The cohort will consist of original subjects of the SOX Trial who consent to participate in the extension to follow up sub study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PTS and PTS severity
Measured: 3 year 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 completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: Sub study was not pursued as overall trial was negative
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postphlebitic SyndromeStudies 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
- 0 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
- NCT01615692
- Sponsor's protocol ID
- MOP-102610
- Other IDs
- ISRCTN71334751; NCT00143598
- Status last verified
- Apr 2018
- First submitted
- 1 Jun 2012
- Last updated
- 18 Apr 2018
- 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 17711595
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Extension to Follow up Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX Trial)
- ClinicalTrials.gov ID
- NCT01615692
- Acronym / sponsor ID
- MOP-102610
- Keywords
- Elastic Stockings, Stockings, Compression, Randomized Controlled Trials, Quality of Life
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sub study was not pursued as overall trial was negative
- Enrolment
- 0 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
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- 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 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.
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. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 36-mth follow up visit | – | –The cohort will consist of original subjects of the SOX Trial who consent to participate in the extension to follow up 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) who did not develop PTS by 2 years follow up.
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 (5 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
Incidence of PTS and PTS severity
Time frame: 3 year follow up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- 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.
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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
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postphlebitic Syndrome and Post-Thrombotic Syndrome, run by Sir Mortimer B. Davis - Jewish General Hospital at 20 sites in Canada.
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 5 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: withdrawn, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of PTS and PTS severity (time frame: 3 year follow up). 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 NCT01615692, which also lists 1 linked publication.
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 18 Apr 2018.