To assess the costs and effects of tailoring the duration of elastic compression stocking (ECS) therapy after deep vein thrombosis (DVT) to individual patients needs.
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of patients with Post Thrombotic Syndrome (PTS) at two year
follow-up.
Secondary outcome
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.
Background summary
The evidence sustaining the value of Elastic compression stocking (ECS) therapy
following acute deep venous thrombosis (DVT) is derived from 2 randomized
clinical trials. Incidences of PTS were observed to be reduced significantly
(approximately 50%) by application of ECS therapy with a duration of 24 months
in all patients. However, based on these studies it is still not clear whether
all patients benefit to the same extent from ECS therapy or what the optimal
duration of ECS therapy for individual patients should be. ECS therapy is not
only costly, inconvenient and demanding but sometimes also even debilitating.
Only one study so far assessed whether prolonged duration of ECS therapy was
superior to 6 months of ECS therapy following an event of proximal DVT. In this
study no significant difference in the incidence of post thrombotic syndrome
(PTS) was found. Our study will provide the lacking information on the
individual benefit to patients and the optimal duration of ECS therapy.
Alongside the clinical trial, a cost-effectiveness analysis from a societal
perspective will elucidate the cost-effectiveness of this approach. In the
Netherlands, 25.000 patients each year are diagnosed with Deep Venous
Thrombosis (DVT). Substantial costs could be saved by tailoring therapy to
individual needs and as a result the quality of life for individual patients
can be expected to improve.
Study objective
To assess the costs and effects of tailoring the duration of elastic
compression stocking (ECS) therapy after deep vein thrombosis (DVT) to
individual patients needs.
Study design
a multi-center, randomized, allocation concealed, single-blinded clinical trial
in patients with proximal deep venous thrombosis (DVT) with a follow-up of 24
months.
Intervention
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.
Study burden and risks
The study burden for patients is kept to a minimum and will comprise of regular
visits and questionnaires. The study burden for clinicians is low. Patients
will be seen at regular intervals (3, 6, 12 and 24 months) at the outpatient
clinic. Patients will receive questionnaires preceding their visits. A clinical
score to assess post thrombotic complaints will be performed at the out clinic
visits. Based on our previous findings we expect that due to individual
tailoring of therapy, 50% of patients will need ECS therapy for a period of
maximum 12 months, instead of 24 months. HRQOL may be positively affected.
Shorter therapy duration is not anticipated to have a negative implication on
the incidence of PTS during the 24 months period of follow-up (pilot data; J
Vasc Surg 2010, in press).
P Debyelaan 25
Maastricht 6202 AZ
NL
P Debyelaan 25
Maastricht 6202 AZ
NL
Listed location countries
Age
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
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 < 6 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32073.068.10 |