The Ideal Deep Venous Thrombosis (DVT) Study

Conditions

Postthrombotic Syndrome

Keywords

Elastic Compression Stockings, Deep Venous Thrombosis, Post Thrombotic Syndrome

Brief summary

In the Netherlands, 25.000 patients each year are diagnosed with Deep Venous Thrombosis (DVT). Elastic compression stocking (ECS) therapy reduces the incidence of post thrombotic syndrome (PTS) following DVT from 50% without ECS to 20-30% after ECS therapy for two years. It is however unclear whether all patients benefit to the same extent from this 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. 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. This study aims to assess the costs and effects of tailoring the duration of ECS therapy after DVT to individual patients needs. ECS therapy with a standard duration of 24 months will be compared with tailored ECS therapy, following an initial therapeutic period of 6 months, in patients with acute proximal DVT. The primary outcome is the percentage of patients with PTS at two year follow-up. This is a multi-center, randomized, allocation concealed, single-blinded clinical trial.

Aaron F.J. Iding, Vincent ten Cate, Hugo Ten Cate, Philipp S. Wild, Arina J. ten Cate‐Hoek

Blood Advances2025-03-143 citations

10.1182/bloodadvances.2025015829

Individually shortened duration versus standard duration of elastic compression therapy for prevention of post-thrombotic syndrome: a cost-effectiveness analysis.

Amin EE, Ten Cate-Hoek AJ, Bouman AC, Meijer K, Tick L, Middeldorp S, Mostard G, Ten Wolde M, van den Heiligenberg S, van Wissen S, van de Poel M, Villalta S, Serné E, Otten HM, Klappe E, Prandoni P, Prins MH, Ten Cate H, Joore MA.

2018-10-098 citations

10.1016/s2352-3026(18)30151-0

Reduced incidence of vein occlusion and postthrombotic syndrome after immediate compression for deep vein thrombosis.

Amin EE, Bistervels IM, Meijer K, Tick LW, Middeldorp S, Mostard G, van de Poel M, Serné EH, Otten HM, Klappe EM, Joore MA, Ten Cate H, Ten Wolde M, Ten Cate-Hoek AJ.

2018-09-2034 citations

10.1182/blood-2018-03-836783

Clinical and economic impact of compression in the acute phase of deep vein thrombosis

Elham E Amin, Manuela Joore, Hugo Ten Cate, Karina Meijer, Lidwine W. Tick et al. (17 authors)

Journal of Thrombosis and Haemostasis2018-06-0131 citations

10.1111/jth.14163

Individualised versus standard duration of elastic compression therapy for prevention of post-thrombotic syndrome (IDEAL DVT): a multicentre, randomised, single-blind, allocation-concealed, non-inferiority trial.

Ten Cate-Hoek AJ, Amin EE, Bouman AC, Meijer K, Tick LW, Middeldorp S, Mostard GJM, Ten Wolde M, van den Heiligenberg SM, van Wissen S, van de Poel MH, Villalta S, Serné EH, Otten HM, Klappe EH, Bistervels IM, Lauw MN, Piersma-Wichers M, Prandoni P, Joore MA, Prins MH, Ten Cate H, IDEAL DVT investigators.

2017-12-0560 citations

10.1016/s2352-3026(17)30227-2

The IDEAL DVT study, individualised duration elastic compression therapy against long-term duration of therapy for the prevention of post-thrombotic syndrome: protocol of a randomised controlled trial

Arina J. ten Cate‐Hoek, A.C. Bouman, Manuela Joore, Martin H. Prins, Hugo Ten Cate

BMJ Open2014-09-0128 citations

10.1136/bmjopen-2014-005265

Interventions

DEVICEIndividually tailored duration of elastic compression therapy

Individually tailored duration of elastic compression therapy,based on signs and symptoms according to the Villalta scale, following an initial therapeutic period of 6 months

DEVICEElastic compression therapy with a standard duration of 24 months

Elastic compression therapy with a standard duration of 24 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Legal age (18 yrs) * Informed consent * Acute objectively documented DVT of the leg * Adequate anticoagulation

Exclusion criteria

* Previous DVT in the affected leg * Recurrent DVT in the first 6 months following inclusion * Preexistent venous insufficiency (skin signs C4-C6 on CEAP score or requiring ECS therapy) * Contraindication for elastic compression therapy (arterial insufficiency) * Active thrombolysis * Life expectancy \< 6 months

Design outcomes

Primary

Measure	Time frame
The occurrence of PTS at 24 months after the event of acute DVT	At 24 months after the event of the acute DVT

Secondary

Measure	Time frame	Description
Recurrent venous thrombosis	24 months	—
Mortality due to venous thrombosis	24 months	—
Health Related Quality of Life (HRQOL)	Baseline, 3, 6, 12 and 24 months	HRQOL, will be measured by questionnaires SF-36, EuroQol-5D, Veines-Qol Dutch translated
Costs	3, 6, 12, 24 months	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
Patient Preferences	baseline, 24 months	Patient preferences will be elicited by conducting a discrete choice experiment (DCE)

Countries

Italy, Netherlands

Outcome results

None listed