The 36-month Extension to Follow up Sub Study

The Extension to Follow up Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX Trial)

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01615692

Enrollment

Registered

2012-06-11

Start date

2004-06-30

Completion date

2015-06-30

Last updated

2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis, Postphlebitic Syndrome, Post-Thrombotic Syndrome

Keywords

Elastic Stockings, Stockings, Compression, Randomized Controlled Trials, Quality of Life

Brief summary

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.

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Incidence of PTS and PTS severity	3 year follow up

Countries

Canada

Outcome results