Phase 3
N=806
The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome
Deep Venous Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT00143598 ↗Enrolled (actual)
806
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Incidence of Post-thrombotic Syndrome (PTS) — 44; 37 participants — p=.58
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Knee-length, graduated elastic compression stocking (Device); Knee-length, placebo stocking (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Post-thrombotic Syndrome (PTS) |
44; 37 | .58 |
| SECONDARY Severity of PTS, Including Incidence of Venous Ulcer |
185; 178; 119; 111; 30; 37 | — |
| SECONDARY Incidence of Objectively Confirmed Recurrent Venous Thromboembolism (VTE), Death From VTE and Major Bleeding |
33; 38; 0; 0; 11; 14 | — |
| SECONDARY Quality of Life |
46.7; 47.5; 52.7; 52.5; 56.6; 57.4 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00143598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.