The Ideal Deep Venous Thrombosis (DVT) Study

NCT ID: NCT01429714

Last Updated: 2018-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 865 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-22
• Study Completion Date: 2017-07-01

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.

Conditions

Postthrombotic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention: individually tailored ECS

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.

Group Type: EXPERIMENTAL

Individually tailored duration of elastic compression therapy

Intervention Type: DEVICE

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

Control: ECS 24 months

Elastic compression therapy with a standard duration of 24 months

Group Type: ACTIVE_COMPARATOR

Elastic compression therapy with a standard duration of 24 months

Intervention Type: DEVICE

Elastic compression therapy with a standard duration of 24 months

Interventions

Individually 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

Intervention Type: DEVICE

Elastic compression therapy with a standard duration of 24 months

Elastic compression therapy with a standard duration of 24 months

Intervention Type: DEVICE

Other Intervention Names

Custom made flat knitted, knee length, class III stockings (Mediven ®550, ankle pressure 40 mmHg); Custom made flat knitted, knee length, class III stockings (Mediven ®550, ankle pressure 40 mmHg)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arina J ten Cate-Hoek, MD, PhD, MpH

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Centre

Locations

Azienda Ospedaliera di Padova

Padua, , Italy

Treviso Aziende

Treviso, , Italy

Flevohospital

Almere Stad, , Netherlands

VU Medical Centre

Amsterdam, , Netherlands

Slotervaart hospital

Amsterdam, , Netherlands

OLVG

Amsterdam, , Netherlands

AMC

Amsterdam, , Netherlands

Maxima Medical Centre

Eindhoven, , Netherlands

UMCG

Groningen, , Netherlands

Atrium Medical Centre

Heerlen, , Netherlands

Westfriesgasthuis

Hoorn, , Netherlands

Maastricht University Medical Centre

Maastricht, , Netherlands

UMC Nijmegen Radboud

Nijmegen, , Netherlands

Laurentius ziekenhuis

Roermond, , Netherlands

Countries

Italy; Netherlands

References

Ten Cate-Hoek AJ, Bouman AC, Joore MA, Prins M, Ten Cate H; IDEAL DVT trial investigators. 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. BMJ Open. 2014 Sep 4;4(9):e005265. doi: 10.1136/bmjopen-2014-005265.

Reference Type: BACKGROUND

PMID: 25190617 (View on PubMed)

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, Serne EH, Otten HM, Klappe EH, Bistervels IM, Lauw MN, Piersma-Wichers M, Prandoni P, Joore MA, Prins MH, Ten Cate H; IDEAL DVT investigators. 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. Lancet Haematol. 2018 Jan;5(1):e25-e33. doi: 10.1016/S2352-3026(17)30227-2. Epub 2017 Dec 5.

Reference Type: BACKGROUND

PMID: 29217387 (View on PubMed)

Iding AFJ, Ten Cate V, Ten Cate H, Wild PS, Ten Cate-Hoek AJ. Untangling profiles of postthrombotic syndrome using unsupervised machine learning. Blood Adv. 2025 Jul 22;9(14):3631-3641. doi: 10.1182/bloodadvances.2025015829.

Reference Type: DERIVED

PMID: 40086064 (View on PubMed)

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, Serne E, Otten HM, Klappe E, Prandoni P, Prins MH, Ten Cate H, Joore MA. Individually shortened duration versus standard duration of elastic compression therapy for prevention of post-thrombotic syndrome: a cost-effectiveness analysis. Lancet Haematol. 2018 Nov;5(11):e512-e519. doi: 10.1016/S2352-3026(18)30151-0. Epub 2018 Oct 9.

Reference Type: DERIVED

PMID: 30314712 (View on PubMed)

Amin EE, Bistervels IM, Meijer K, Tick LW, Middeldorp S, Mostard G, van de Poel M, Serne EH, Otten HM, Klappe EM, Joore MA, Ten Cate H, Ten Wolde M, Ten Cate-Hoek AJ. Reduced incidence of vein occlusion and postthrombotic syndrome after immediate compression for deep vein thrombosis. Blood. 2018 Nov 22;132(21):2298-2304. doi: 10.1182/blood-2018-03-836783. Epub 2018 Sep 20.

Reference Type: DERIVED

PMID: 30237155 (View on PubMed)

Amin EE, Joore MA, Ten Cate H, Meijer K, Tick LW, Middeldorp S, Mostard GJM, Ten Wolde M, van den Heiligenberg SM, van Wissen S, van de Poel MHW, Villalta S, Serne EH, Otten HM, Klappe EH, Prandoni P, Ten Cate-Hoek AJ. Clinical and economic impact of compression in the acute phase of deep vein thrombosis. J Thromb Haemost. 2018 Jun 1. doi: 10.1111/jth.14163. Online ahead of print.

Reference Type: DERIVED

PMID: 29856509 (View on PubMed)

Other Identifiers

80-82310-97-11017

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

10-2-026

Identifier Type: -

Identifier Source: org_study_id