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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

806

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jun 2004

Longer than P75 for phase_3

Geographic Reach

2 countries

25 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.7 years study duration

Study Start

First participant enrolled

June 1, 2004

Completed

1.3 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed

6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed

2.5 years until next milestone

Results Posted

Study results publicly available

August 18, 2014

Completed

Last Updated

August 18, 2014

Status Verified

August 1, 2014

Enrollment Period

7.7 years

First QC Date

September 1, 2005

Results QC Date

June 3, 2014

Last Update Submit

August 15, 2014

Conditions

Deep Venous Thrombosis

Keywords

Postphlebitic SyndromePost-Thrombotic SyndromeElastic StockingsStockings, CompressionRandomized Controlled TrialsQuality of Life

Outcome Measures

Primary Outcomes (1)

Incidence of Post-thrombotic Syndrome (PTS)
During 2-year follow up

Secondary Outcomes (3)

Severity of PTS, Including Incidence of Venous Ulcer
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
24 months

Study Arms (2)

Active ECS

ACTIVE COMPARATOR

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

Device: Knee-length, graduated elastic compression stocking

Placebo ECS

PLACEBO COMPARATOR

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

Device: Knee-length, placebo stocking

Interventions

Knee-length, graduated elastic compression stockingDEVICE

Worn daily for 2 years, 30-40 mm Hg

Active ECS

Knee-length, placebo stockingDEVICE

Worn daily for two years

Placebo ECS

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Sir Mortimer B. Davis - Jewish General Hospitallead
Canadian Institutes of Health Research (CIHR)collaborator
Sigvaris Corporationcollaborator

Study Sites (25)

Henry Ford Health Systerm

Detroit, Michigan, 48202, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Victoria Heart Institute Foundation

Victoria, British Columbia, V8R 4R2, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

QE II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Hamilton Health Sciences - General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Hamilton Health Sciences - Chedoke Division

Hamilton, Ontario, L8N 3Z5, Canada

Location

Hamilton Health Sciences - McMaster University Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8P 3B6, Canada

Location

Hamilton Health Sciences - Henderson General Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

The Ottawa Hospital, Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

Sunnybrook & Women's College Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Centre Hospitalier Pierre-Boucher

Longueuil, Quebec, J4M 2A5, Canada

Location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

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

Montreal, Quebec, H2L 4M1, Canada

Location

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

Montreal, Quebec, H2W 1T8, Canada

Location

Royal Victoria Hospital - McGill University Health Centre

Montreal, Quebec, H3A 1A1, Canada

Location

Sir Mortimer B. Davis - Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

St. Mary's Hospital Center

Montreal, Quebec, H3T 1M5, Canada

Location

Montreal General Hospital - McGill University Health Centre

Montreal, Quebec, H4G 1A4, Canada

Location

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus

Québec, Quebec, G1J 1Z4, Canada

Location

Related Publications (3)

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.
PMID: 17711595BACKGROUND
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.
PMID: 24315521RESULT
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.
PMID: 25183442DERIVED

MeSH Terms

Conditions

Venous ThrombosisPostphlebitic SyndromePostthrombotic Syndrome

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPhlebitisPeripheral Vascular DiseasesVenous Insufficiency

Limitations and Caveats

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.

Results Point of Contact

Title: Dr. Susan R Kahn
Organization: Centre for Clinical Epidemiology, Jewish General Hospital

Study Officials

Susan R. Kahn, M.D., M.Sc.
Sir Mortimer B. Davis - Jewish General Hospital
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: SOX Trial Principal Investigator

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

June 1, 2004

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

August 18, 2014

Results First Posted

August 18, 2014

Record last verified: 2014-08

Locations

US(3)CA(22)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Active ECS

Placebo ECS

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (25)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Active ECS

Placebo ECS

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (25)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations