Individually tailored elastic compression therapy after deep venous thrombosis (DVT).

Individually tailored elastic compression therapy after deep venous thrombosis in relation to the incidence of post thrombotic .syndrome. A multi-center, randomized, allocation concealed, single blinded clinical trial in patients with acute proximal DVT with a follow-up of 24 months.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20395

Enrollment

864

Registered

2010-11-09

Start date

2011-03-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Problem studied: Post thrombotic syndrome. Preventive intervention: elastic compression stockings (ECS). Patients studied: patients after an acute event of DVT. Current practice is to prescribe ECS for 24 months after an event of acute DVT. It is currently not clear whether all patients benefit to the same extent from ECS therapy, or what the optimal duration for individual patients should be. Keywords: Elastic Compression Stockings, Deep Venous Thrombosis, Post Thrombotic Syndrome.

Interventions

Elastic compression therapy with a standard duration of 24 months compared to individually tailored duration of elastic compression therapy, following an initial therapeutic period of 6 months, based

Eligibility

Inclusion criteria

Inclusion criteria: 1. Legal age (18 yrs); 2. Informed consent; 3. Acute objectively documented DVT of the leg; 4. Adequate anticoagulation.

Exclusion criteria

Exclusion criteria: 1. Previous DVT in the affected leg; 2. Recurrent DVT in the first 6 months following inclusion; 3. Preexistent venous insufficiency ( skin signs C4-C6 on CEAP score or requiring ECS therapy); 4. Contraindication for elastic compression therapy ( arterial insufficiency); 5. Active thrombolysis; 6. Life expectancy < 6 months.

Design outcomes

Primary

Measure	Time frame
The occurrence of PTS at 24 months after the event of acute DVT (the observers will be blinded to the allocated treatment arm).	—

Secondary

Measure	Time frame
1. Health Related Quality of Life (HRQOL), will be measured by questionnaires SF-36, EuroQol-5D, Veines-Qol Dutch translated (time point baseline, 3, 6, 12 and 24 months); 2. Recurrent venous thrombosis (time point 24 months); 3. Mortality due to venous thrombosis (time point 24 months); 4. Costs will include direct costs (e.g. medical therapy) and indirect costs (e.g. travel) and will be measured by case record forms, hospital data and 5 retrospective cost-questionnaires (time point 3, 6, 12, 24 months); 5. Patient Preference will be elicited by conducting a discrete choice experiment (DCE) at time point 12 months.	—

Measure

Time frame

1. Health Related Quality of Life (HRQOL), will be measured by questionnaires SF-36, EuroQol-5D, Veines-Qol Dutch translated (time point baseline, 3, 6, 12 and 24 months); 2. Recurrent venous thrombosis (time point 24 months); 3. Mortality due to venous thrombosis (time point 24 months); 4. Costs will include direct costs (e.g. medical therapy) and indirect costs (e.g. travel) and will be measured by case record forms, hospital data and 5 retrospective cost-questionnaires (time point 3, 6, 12, 24 months); 5. Patient Preference will be elicited by conducting a discrete choice experiment (DCE) at time point 12 months.

—

Contacts

Public ContactA.J. Cate-Hoek, ten

P. Debyelaan 25

arina.tencate@epid.unimaas.nl+31 (0)43 3871243

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)