The 36-month Extension to Follow up Sub Study

Sir Mortimer B. Davis - Jewish General Hospital

Overview

The purpose of this study is to evaluate leg health for one additional year in patients with symptomatic proximal deep venous thrombosis who did not already develop Post-Thrombotic Syndrome (PTS) during the 2 years of follow up in the SOX Trial.

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) for two years following DVT could be helpful in preventing or delaying onset of PTS at three years, however data supporting this is limited.

Study Type

OBSERVATIONAL

Conditions

Postphlebitic Syndrome Post-Thrombotic Syndrome Deep Vein Thrombosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Victoria Heart Institute Foundation

Victoria, British Columbia, Canada

Outcomes

Primary Outcomes

Incidence of PTS and PTS severity

Time frame: 3 year follow up

Data from ClinicalTrials.gov

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