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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN71334751 | Registry Identifier | ISRCTN |
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Sigvaris Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active ECS | Active Comparator | Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle. |
|
| Placebo ECS | Placebo Comparator | Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Knee-length, graduated elastic compression stocking | Device | Worn daily for 2 years, 30-40 mm Hg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Post-thrombotic Syndrome (PTS) | During 2-year follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan R. Kahn, M.D., M.Sc. | Sir Mortimer B. Davis - Jewish General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health Systerm | Detroit | Michigan | 48202 | United States | ||
| Duke University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17711595 | Background | 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. | |
| 24315521 |
| Label | URL |
|---|---|
| Biomarker Sub Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX) Trial (Bio-SOX) | View source |
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Patients were excluded if they had a contraindication to the use of compression stockings, an expected life span of <6 months, geographical inaccessibility, were unable to apply stockings, or received thrombolytic therapy for the initial treatment of acute deep vein thrombosis (DVT).
Between June, 2004, and February, 2010, we enrolled patients in 24 centres in Canada and the USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active ECS | Active Elastic Compression Stockings. 30-40 mm Hg |
| FG001 | Placebo ECS | Placebo stockings with identical appearance but less than 5 mm Hg compression at the ankle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Knee-length, placebo stocking | Device | Worn daily for two years |
|
| 6-24 months. |
| Incidence of Objectively Confirmed Recurrent Venous Thromboembolism (VTE), Death From VTE and Major Bleeding | During 2-year follow up |
| 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. | 24 months |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Oklahoma University Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Victoria Heart Institute Foundation | Victoria | British Columbia | V8R 4R2 | Canada |
| St. Boniface General Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
| QE II Health Sciences Centre | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Hamilton Health Sciences - General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| Hamilton Health Sciences - Chedoke Division | Hamilton | Ontario | L8N 3Z5 | Canada |
| Hamilton Health Sciences - McMaster University Medical Centre | Hamilton | Ontario | L8N 3Z5 | Canada |
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8P 3B6 | Canada |
| Hamilton Health Sciences - Henderson General Hospital | Hamilton | Ontario | L8V 1C3 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 4G5 | Canada |
| The Ottawa Hospital, Civic Campus | Ottawa | Ontario | K1Y 4E9 | Canada |
| Sunnybrook & Women's College Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| University Health Network - Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Centre Hospitalier Pierre-Boucher | Longueuil | Quebec | J4M 2A5 | Canada |
| Hôpital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Centre Hospitalier de l'Université de Montréal - Hôpital Notre-Dame | Montreal | Quebec | H2L 4M1 | Canada |
| Centre Hospitalier de l'Université de Montréal - Hôpital Hôtel-Dieu | Montreal | Quebec | H2W 1T8 | Canada |
| Royal Victoria Hospital - McGill University Health Centre | Montreal | Quebec | H3A 1A1 | Canada |
| Sir Mortimer B. Davis - Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| St. Mary's Hospital Center | Montreal | Quebec | H3T 1M5 | Canada |
| Montreal General Hospital - McGill University Health Centre | Montreal | Quebec | H4G 1A4 | Canada |
| Hôpital du Sacré-Coeur de Montréal | Montreal | Quebec | H4J 1C5 | Canada |
| Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus | Québec | Quebec | G1J 1Z4 | Canada |
| 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. |
| 25183442 | Derived | 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. |
| COMPLETED |
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| NOT COMPLETED |
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806 patients were randomly assigned to an intervention. Three patients were identified as ineligible soon after randomization and were excluded from further analysis (ie, modified intention-to-treat). In the active ECS group, one patient had no DVT and in the placebo ECS group one patient had a previous DVT and another patient was moribund.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active ECS | Active Elastic Compression Stockings. 30-40 mm Hg |
| BG001 | Placebo ECS | Placebo stockings with identical appearance but less than 5 mm Hg compression at the ankle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Outpatients | Number | participants |
| ||||||||||||||||
| Body-mass index, kg/m2 | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Time from DVT diagnosis to randomization | Mean | Standard Deviation | days |
| |||||||||||||||
| Side of DVT | Number | participants |
| ||||||||||||||||
| Most proximal extent of DVT | Number | participants |
| ||||||||||||||||
| Villalta score at baseline | 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. | Mean | Standard Deviation | Score on a scale |
| ||||||||||||||
| Concurrent pulmonary embolism | Number | participants |
| ||||||||||||||||
| Venous thrombosis risk factors | Number | participants |
| ||||||||||||||||
| Type of DVT Treatment | Number | participants |
| ||||||||||||||||
| Duration of DVT Treatment | Median | Inter-Quartile Range | days |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Post-thrombotic Syndrome (PTS) | Intention to treat. | Posted | Number | participants | During 2-year follow up |
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| Secondary | 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. | Highest Villalta score at or after 6 month visit (missing for 48 patients in each group). | Posted | Number | participants | 6-24 months. |
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| Secondary | Incidence of Objectively Confirmed Recurrent Venous Thromboembolism (VTE), Death From VTE and Major Bleeding | Posted | Number | participants | During 2-year follow up |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Patients who completed the SF-36 and VEINES-QOL at 24 months follow-up. | Posted | Mean | Standard Deviation | Scores on a scale | 24 months |
|
24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active ECS | Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle. | 0 | 409 | 8 | 409 | ||
| EG001 | Placebo ECS | Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle. | 0 | 394 | 7 | 394 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash/Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
While 14% withdrew or were lost to follow-up (F/U), the total rate of withdrawal, loss to F/U and death was less than what was projected. Adherence to study stockings tended to diminish over F/U; this occurred to a similar degree in both groups.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan R Kahn | Centre for Clinical Epidemiology, Jewish General Hospital | 514-340-8222 | 7587 | susan.kahn@mcgill.ca |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D011186 | Postphlebitic Syndrome |
| D054070 | Postthrombotic Syndrome |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010689 | Phlebitis |
| D016491 | Peripheral Vascular Diseases |
| D014689 | Venous Insufficiency |
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| 40-65 years |
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| >65 years |
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| Male |
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| Right |
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| Bilateral |
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| Common femoral vein |
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| Femoral Vein |
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| Popliteal vein |
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| Trauma, past 3 months |
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| Immobilised in past month |
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| Active cancer |
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| Pregnant, post partum, OCT, or HRT |
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| Family history of venous thromboembolism |
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| Unfractionated heparin |
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| Warfarin |
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| Investigational anitcoagulant |
|
| Duration of Oral Anti-Coagulation (OAC) |
|
|
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| Units | Counts |
|---|---|
| Participants |
|
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