Overview

This trial is active, not recruiting.

Conditions postphlebitic syndrome, post-thrombotic syndrome, deep vein thrombosis
Sponsor Sir Mortimer B. Davis - Jewish General Hospital
Collaborator Canadian Institutes of Health Research (CIHR)
Start date June 2004
End date June 2015
Trial size 300 participants
Trial identifier NCT01615692, ISRCTN71334751; NCT00143598, MOP-102610

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
The cohort will consist of original subjects of the SOX Trial who consent to participate in the extension to follow up sub study.

Primary Outcomes

Measure
Incidence of PTS and PTS severity
time frame: 3 year follow up

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Extension to Follow up Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX Trial)
Principal investigator Susan R. Kahn, M.D., M.Sc.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Sir Mortimer B. Davis - Jewish General Hospital.