post phlebetic syndrome
Conditions
Interventions
ECS therapy with a standard duration of 24 months versus tailored ECS therapy
following an initial therapeutic period of 6 months, based on signs and
symptoms according to a Villalta scale.
Sponsors
interne geneeskunde laboratorium hematologie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All adult, consenting, consecutive outpatients with acute objectively documented proximal DVT of the leg •All patients should be treated with a minimum of 5 days of Low Molecular Weight Heparins (LMWH) followed by oral anticoagulants with a target international normalized ratio (INR) of 2-3
Exclusion criteria
Exclusion criteria: Previous DVT in the affected leg •Recurrent DVT in the 6 months following inclusion •Pre-existent venous insufficiency (skin signs C3-C6 on CEAP score or requiring ECS therapy) •Contraindication for elastic compression therapy (e.g. arterial insufficiency) •Active thrombolysis •Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with Post Thrombotic Syndrome (PTS) at two year follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health Related Quality of Life, 2.Costs, 3.Recurrent venous thrombosis, 4. Mortality due to venous thrombosis and 5. Patient preference. Economic evaluation: Cost-effectiveness analysis from a societal perspective for the extrapolation of the trial results a Markov Model will be used. | — |
Countries
Netherlands
Outcome results
None listed