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Postthrombotic SyndromeIDEALNCT01429714

The Ideal Deep Venous Thrombosis (DVT) Study

A study testing Individually tailored duration of elastic compression therapy and Elastic compression therapy with a standard duration of 24 months in people with Postthrombotic Syndrome, run by Maastricht University Medical Center at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postthrombotic Syndrome
What is being tested?
Individually tailored duration of elastic compression therapy and Elastic compression therapy with a standard duration of 24 months
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
865 participants
Where
14 sitesin 2 countries
Study dates
22 Mar 2011to 1 Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

Netherlands12 sites

  • Flevohospital

    Almere Stad, 1315 RA

  • VU Medical Centre

    Amsterdam, 1007 MB

  • Slotervaart hospital

    Amsterdam, 1066 EC

  • OLVG

    Amsterdam, 1091 AC

  • AMC

    Amsterdam, 1105 AZ

  • Maxima Medical Centre

    Eindhoven, 5631 BM

  • UMCG

    Groningen, 9713 GZ

  • Atrium Medical Centre

    Heerlen, 6419 PC

  • Westfriesgasthuis

    Hoorn, 1091 AC

  • Maastricht University Medical Centre

    Maastricht, 6202 AZ

  • UMC Nijmegen Radboud

    Nijmegen, 6525 GA

  • Laurentius ziekenhuis

    Roermond, 6043 CV

Other trials in Netherlands

Italy2 sites

  • Azienda Ospedaliera di Padova

    Padua, 35128

  • Treviso Aziende

    Treviso

Other trials in Italy

About this study

Official title: Individually Tailored Elastic Compression Therapy After Deep Venous Thrombosis in Relation to the Incidence of Post Thrombotic Syndrome, a Randomized Multicenter Trial

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.

Read more

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.

Being tested
Individually tailored duration of elastic compression therapy, Elastic compression therapy with a standard duration of 24 months
Keywords
Elastic Compression Stockings, Deep Venous Thrombosis, Post Thrombotic Syndrome
Medical subject headings
Postthrombotic Syndrome, Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individually tailored duration of elastic compression therapyDevice

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

    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

  • Elastic compression therapy with a standard duration of 24 monthsDevice

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

    Elastic compression therapy with a standard duration of 24 months

Study groups in NCT01429714
Study groupRoleWhat they receive
Intervention: individually tailored ECSExperimentalIndividually tailored duration of elastic compression therapy, based on signs and symptoms according to the Villalta scale, following an initial therapeutic period of 6 months.
Receives: Device: Individually tailored duration of elastic compression therapy
Control: ECS 24 monthsActive comparatorElastic compression therapy with a standard duration of 24 months
Receives: Device: Elastic compression therapy with a standard duration of 24 months

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The occurrence of PTS at 24 months after the event of acute DVT

    Measured: At 24 months after the event of the acute DVT

Secondary outcomes (5)

  1. Health Related Quality of Life (HRQOL)

    HRQOL, will be measured by questionnaires SF-36, EuroQol-5D, Veines-Qol Dutch translated

    Measured: Baseline, 3, 6, 12 and 24 months

  2. Recurrent venous thrombosis

    Measured: 24 months

  3. Mortality due to venous thrombosis

    Measured: 24 months

  4. Costs

    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

    Measured: 3, 6, 12, 24 months

  5. Patient Preferences

    Patient preferences will be elicited by conducting a discrete choice experiment (DCE)

    Measured: baseline, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2011 (estimated)
  2. Study start22 Mar 2011
  3. Primary completion1 Jul 2017
  4. Study completion1 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
865 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01429714
Sponsor's protocol ID
10-2-026
Other IDs
80-82310-97-11017
Acronym
IDEAL
Status last verified
Mar 2018
First submitted
24 Aug 2011
Last updated
10 Apr 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25190617

  • 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.

    PubMed 29217387

  • 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.

    PubMed 40086064

  • 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.

    PubMed 30314712

  • 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.

    PubMed 30237155

  • 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.

    PubMed 29856509

Questions about this trial

What is this clinical trial studying?

A study testing Individually tailored duration of elastic compression therapy and Elastic compression therapy with a standard duration of 24 months in people with Postthrombotic Syndrome, run by Maastricht University Medical Center at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Netherlands, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The occurrence of PTS at 24 months after the event of acute DVT (time frame: At 24 months after the event of the acute DVT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01429714, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.

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