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

Primary Purpose

Deep Venous Thrombosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Knee-length, graduated elastic compression stocking
Knee-length, placebo stocking
Sponsored by
Sir Mortimer B. Davis - Jewish General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Deep Venous Thrombosis focused on measuring Postphlebitic Syndrome, Post-Thrombotic Syndrome, Elastic Stockings, Stockings, Compression, Randomized Controlled Trials, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henry Ford Health Systerm
  • Duke University Medical Center
  • Oklahoma University Health Sciences Center
  • Victoria Heart Institute Foundation
  • St. Boniface General Hospital
  • QE II Health Sciences Centre
  • Hamilton Health Sciences - General Hospital
  • Hamilton Health Sciences - Chedoke Division
  • Hamilton Health Sciences - McMaster University Medical Centre
  • St. Joseph's Healthcare Hamilton
  • Hamilton Health Sciences - Henderson General Hospital
  • London Health Sciences Centre
  • The Ottawa Hospital, Civic Campus
  • Sunnybrook & Women's College Health Sciences Centre
  • University Health Network - Toronto General Hospital
  • Centre Hospitalier Pierre-Boucher
  • Hôpital Maisonneuve-Rosemont
  • Centre Hospitalier de l'Université de Montréal - Hôpital Notre-Dame
  • Centre Hospitalier de l'Université de Montréal - Hôpital Hôtel-Dieu
  • Royal Victoria Hospital - McGill University Health Centre
  • Sir Mortimer B. Davis - Jewish General Hospital
  • St. Mary's Hospital Center
  • Montreal General Hospital - McGill University Health Centre
  • Hôpital du Sacré-Coeur de Montréal
  • Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active ECS

Placebo ECS

Arm Description

Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.

Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.

Outcomes

Primary Outcome Measures

Incidence of Post-thrombotic Syndrome (PTS)

Secondary Outcome Measures

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

Full Information

First Posted
September 1, 2005
Last Updated
August 15, 2014
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Collaborators
Canadian Institutes of Health Research (CIHR), Sigvaris Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00143598
Brief Title
The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome
Official Title
The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome After Symptomatic Proximal Deep Venous Thrombosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Collaborators
Canadian Institutes of Health Research (CIHR), Sigvaris Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Venous Thrombosis
Keywords
Postphlebitic Syndrome, Post-Thrombotic Syndrome, Elastic Stockings, Stockings, Compression, Randomized Controlled Trials, Quality of Life

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
806 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active ECS
Arm Type
Active Comparator
Arm Description
Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
Arm Title
Placebo ECS
Arm Type
Placebo Comparator
Arm Description
Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
Intervention Type
Device
Intervention Name(s)
Knee-length, graduated elastic compression stocking
Intervention Description
Worn daily for 2 years, 30-40 mm Hg
Intervention Type
Device
Intervention Name(s)
Knee-length, placebo stocking
Intervention Description
Worn daily for two years
Primary Outcome Measure Information:
Title
Incidence of Post-thrombotic Syndrome (PTS)
Time Frame
During 2-year follow up
Secondary Outcome Measure Information:
Title
Severity of PTS, Including Incidence of Venous Ulcer
Description
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.
Time Frame
6-24 months.
Title
Incidence of Objectively Confirmed Recurrent Venous Thromboembolism (VTE), Death From VTE and Major Bleeding
Time Frame
During 2-year follow up
Title
Quality of Life
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan R. Kahn, M.D., M.Sc.
Organizational Affiliation
Sir Mortimer B. Davis - Jewish General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Health Systerm
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Oklahoma University Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Victoria Heart Institute Foundation
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
QE II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Hamilton Health Sciences - General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Hamilton Health Sciences - Chedoke Division
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Hamilton Health Sciences - McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8P 3B6
Country
Canada
Facility Name
Hamilton Health Sciences - Henderson General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
The Ottawa Hospital, Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Sunnybrook & Women's College Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University Health Network - Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Centre Hospitalier Pierre-Boucher
City
Longueuil
State/Province
Quebec
ZIP/Postal Code
J4M 2A5
Country
Canada
Facility Name
Hôpital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Centre Hospitalier de l'Université de Montréal - Hôpital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Centre Hospitalier de l'Université de Montréal - Hôpital Hôtel-Dieu
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Royal Victoria Hospital - McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Sir Mortimer B. Davis - Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
St. Mary's Hospital Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1M5
Country
Canada
Facility Name
Montreal General Hospital - McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4G 1A4
Country
Canada
Facility Name
Hôpital du Sacré-Coeur de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17711595
Citation
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.
Results Reference
background
PubMed Identifier
24315521
Citation
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.
Results Reference
result
PubMed Identifier
25183442
Citation
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.
Results Reference
derived
Links:
URL
http://clinicaltrials.gov/ct2/show/NCT01615705
Description
Biomarker Sub Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX) Trial (Bio-SOX)

Learn more about this trial

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

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