The 36-month Extension to Follow up Sub Study

Sir Mortimer B. Davis - Jewish General Hospital

Status: Withdrawn

Conditions: Postphlebitic Syndrome; Deep Vein Thrombosis; Post-Thrombotic Syndrome

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01615692

ISRCTN71334751 ( NCT00143598;Registry Identifier)

MOP-102610

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

0 participants in 1 patient group

36-mth follow up visit

Description:

The cohort will consist of original subjects of the SOX Trial who consent to participate in the extension to follow up sub study.