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Trial NCT00143598

Resource URI: http://static.linkedct.org/resource/trials/NCT00143598
PropertyValue
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/18092>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/5958>
linkedct:brief_title The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1060>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/7235>
linkedct:condition <http://static.linkedct.org/resource/condition/3616>
linkedct: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
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date January 2011
linkedct:enrollment 800 (xsd:int)
linkedct:firstreceived_date September 1, 2005
linkedct:has_dmc Yes
linkedct:id NCT00143598
linkedct:intervention <http://static.linkedct.org/resource/intervention/91932>
linkedct:intervention <http://static.linkedct.org/resource/intervention/91933>
rdfs:label Trial NCT00143598
linkedct:lastchanged_date April 23, 2009
linkedct:lead_sponsor_agency Sir Mortimer B. Davis - Jewish General Hospital
linkedct:location <http://static.linkedct.org/resource/location/16535>
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linkedct:nct_id NCT00143598
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome After Symptomatic Proximal Deep Venous Thrombosis
linkedct:org_study_id MCT-63142
linkedct:overall_contact_email susan.kahn@mcgill.ca
linkedct:overall_contact_last_name Susan R. Kahn, M.D., M.Sc.
linkedct:overall_contact_phone 514-340-8222
linkedct:overall_contact_phone_ext 4667
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/56909>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/415>
foaf:page <http://clinicaltrials.gov/show/NCT00143598>
linkedct:phase Phase 3
linkedct:primary_completion_date January 2011
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/62031>
linkedct:secondary_id ISRCTN71334751
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/105027>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/16995>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/32182>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/57098>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/92059>
linkedct:source Sir Mortimer B. Davis - Jewish General Hospital
linkedct:start_date June 2004
linkedct:study_design Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date April 2009