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Deep Venous ThrombosisPhase 3NCT00143598

The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome

A Phase 3 study testing Knee-length, graduated elastic compression stocking in people with Deep Venous Thrombosis, run by Sir Mortimer B. Davis - Jewish General Hospital at 25 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether elastic compression stockings used for 2 years are effective in preventing the post-thrombotic syndrome 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
What is being tested?
Knee-length, graduated elastic compression stocking
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
806 participants
Where
25 sitesin 2 countries
Study dates
Jun 2004to Feb 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

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 2Y9

  • 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, L8P 3B6

  • 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 2M4

  • Centre Hospitalier de l'Université de Montréal - Hôpital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • Centre Hospitalier de l'Université de Montréal - Hôpital Hôtel-Dieu

    Montreal, Quebec, H2W 1T8

  • Royal Victoria Hospital - McGill University Health Centre

    Montreal, Quebec, H3A 1A1

  • Sir Mortimer B. Davis - Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • St. Mary's Hospital Center

    Montreal, Quebec, H3T 1M5

  • Montreal General Hospital - McGill University Health Centre

    Montreal, Quebec, H4G 1A4

  • 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 General Hospital

    Toronto, Ontario, M5G 2C4

  • Victoria Heart Institute Foundation

    Victoria, British Columbia, V8R 4R2

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

United States3 sites

  • Henry Ford Health Systerm

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Oklahoma University Health Sciences Center

    Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Official title: The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome After Symptomatic Proximal Deep Venous Thrombosis

The purpose of this study is to determine whether elastic compression stockings used for 2 years are effective in preventing the post-thrombotic syndrome 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. 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) could be helpful in preventing PTS, however data on their effectiveness are scarce and conflicting.

Comparison(s): Knee-length, 30-40 mm Hg (Class II), graduated ECS worn on the DVT-affected leg daily for 2 years compared to knee-length, inactive (i.e. no compression) stocking, identical in appearance to active ECS, worn on the DVT-affected leg daily for 2 years.

Being tested
Knee-length, graduated elastic compression stocking, Knee-length, placebo stocking
Keywords
Postphlebitic Syndrome, Post-Thrombotic Syndrome, Elastic Stockings, Stockings, Compression, Randomized Controlled Trials, Quality of Life
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.

  • Knee-length, graduated elastic compression stockingDevice

    Worn daily for 2 years, 30-40 mm Hg

  • Knee-length, placebo stockingDevice

    Worn daily for two years

Study groups in NCT00143598
Study groupRoleWhat they receive
Active ECSActive comparatorActive Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
Receives: Device: Knee-length, graduated elastic compression stocking
Placebo ECSPlacebo comparatorPlacebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
Receives: Device: Knee-length, placebo stocking

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Post-thrombotic Syndrome (PTS)

    Measured: During 2-year follow up

Secondary outcomes (3)

  1. Severity of PTS, Including Incidence of Venous Ulcer

    Highest Villalta at or after 6 month visit

    The Villalta Scale for assessment of the post-thrombotic syndrome The Villalta scale has a range of 0-33. A Villalta scale score >4 indicates post-thrombotic syndrome (severity of post-thrombotic syndrome is categorized as 5-9 points, mild; 10-14 points, moderate; >14 points or presence of an ulcer, severe).

    Higher values signify worse outcome. Points on each item in the scale are simply summed to a total score.

    Measured: 6-24 months.

  2. Incidence of Objectively Confirmed Recurrent Venous Thromboembolism (VTE), Death From VTE and Major Bleeding

    Measured: During 2-year follow up

  3. Quality of Life

    The SF-36 is a well-validated generic quality-of-life (QOL) instrument. It includes questions on both physical and mental health. Higher scores indicate a better QOL. The VEINES-QOL is a venous-disease specific QOL measure that consists of 25 items that quantify venous disease effect on QOL, and an embedded symptom sub-questionnaire (VEINES-Sym) with 10 items that measures venous symptoms. Higher scores are associated with better QOL.

    The VEINES-QOL/Sym and SF-36 use the standard method for scoring questionnaires with items with different response scales that is now routinely used. Raw scores are first transformed to z score equivalents (mean, 0; standard deviation, 1), which then are transformed to T scores (mean, 50; standard deviation, 10) to give an easily understood range of scores. A person-specific estimate is imputed for any missing item in cases where the patient answered at least 50% of the items in the scale.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2005 (estimated)
  2. Study startJun 2004
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
806 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00143598
Sponsor's protocol ID
MCT-63142
Other IDs
ISRCTN71334751
Status last verified
Aug 2014
First submitted
1 Sep 2005
Last updated
18 Aug 2014
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

  • Kahn SR, Shapiro S, Wells PS, Rodger MA, Kovacs MJ, Anderson DR, Tagalakis V, Houweling AH, Ducruet T, Holcroft C, Johri M, Solymoss S, Miron MJ, Yeo E, Smith R, Schulman S, Kassis J, Kearon C, Chagnon I, Wong T, Demers C, Hanmiah R, Kaatz S, Selby R, Rathbun S, Desmarais S, Opatrny L, Ortel TL, Ginsberg JS; SOX trial investigators. Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial. Lancet. 2014 Mar 8;383(9920):880-8. doi: 10.1016/S0140-6736(13)61902-9. Epub 2013 Dec 6.

    PubMed 24315521

  • Kahn SR, Shapiro S, Ducruet T, Wells PS, Rodger MA, Kovacs MJ, Anderson D, Tagalakis V, Morrison DR, Solymoss S, Miron MJ, Yeo E, Smith R, Schulman S, Kassis J, Kearon C, Chagnon I, Wong T, Demers C, Hanmiah R, Kaatz S, Selby R, Rathbun S, Desmarais S, Opatrny L, Ortel TL, Galanaud JP, Ginsberg JS. Graduated compression stockings to treat acute leg pain associated with proximal DVT. A randomised controlled trial. Thromb Haemost. 2014 Dec;112(6):1137-41. doi: 10.1160/TH14-05-0430. Epub 2014 Aug 28.

    PubMed 25183442

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Knee-length, graduated elastic compression stocking in people with 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 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: finished, as of the sponsor's last update on 18 Aug 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Post-thrombotic Syndrome (PTS) (time frame: During 2-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 NCT00143598, which also lists 3 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 18 Aug 2014.

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