NCT01429714

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
865

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
2 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

April 10, 2018

Status Verified

March 1, 2018

Enrollment Period

6.3 years

First QC Date

August 24, 2011

Last Update Submit

April 9, 2018

Conditions

Postthrombotic Syndrome

Keywords

Elastic Compression StockingsDeep Venous ThrombosisPost Thrombotic Syndrome

Outcome Measures

Primary Outcomes (1)

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

    At 24 months after the event of the acute DVT

Secondary Outcomes (5)

  • Health Related Quality of Life (HRQOL)

    Baseline, 3, 6, 12 and 24 months

  • Recurrent venous thrombosis

    24 months

  • Mortality due to venous thrombosis

    24 months

  • Costs

    3, 6, 12, 24 months

  • Patient Preferences

    baseline, 24 months

Study Arms (2)

Intervention: individually tailored ECS

EXPERIMENTAL

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.

Device: Individually tailored duration of elastic compression therapy

Control: ECS 24 months

ACTIVE COMPARATOR

Elastic compression therapy with a standard duration of 24 months

Device: Elastic compression therapy with a standard duration of 24 months

Interventions

Individually tailored duration of elastic compression therapyDEVICE

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

Also known as: Custom made flat knitted, knee length, class III stockings (Mediven ®550, ankle pressure 40 mmHg)
Intervention: individually tailored ECS
Elastic compression therapy with a standard duration of 24 monthsDEVICE

Elastic compression therapy with a standard duration of 24 months

Also known as: Custom made flat knitted, knee length, class III stockings (Mediven ®550, ankle pressure 40 mmHg)
Control: ECS 24 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous DVT in the affected leg
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Treviso Aziende

Treviso, Italy

Location

Flevohospital

Almere Stad, 1315 RA, Netherlands

Location

VU Medical Centre

Amsterdam, 1007 MB, Netherlands

Location

Slotervaart hospital

Amsterdam, 1066 EC, Netherlands

Location

OLVG

Amsterdam, 1091 AC, Netherlands

Location

AMC

Amsterdam, 1105 AZ, Netherlands

Location

Maxima Medical Centre

Eindhoven, 5631 BM, Netherlands

Location

UMCG

Groningen, 9713 GZ, Netherlands

Location

Atrium Medical Centre

Heerlen, 6419 PC, Netherlands

Location

Westfriesgasthuis

Hoorn, 1091 AC, Netherlands

Location

Maastricht University Medical Centre

Maastricht, 6202 AZ, Netherlands

Location

UMC Nijmegen Radboud

Nijmegen, 6525 GA, Netherlands

Location

Laurentius ziekenhuis

Roermond, 6043 CV, Netherlands

Location

Related Publications (6)

  • 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.

    PMID: 25190617BACKGROUND

  • 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.

    PMID: 29217387BACKGROUND

  • 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.

    PMID: 40086064DERIVED

  • 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.

    PMID: 30314712DERIVED

  • 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.

    PMID: 30237155DERIVED

  • 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.

    PMID: 29856509DERIVED

MeSH Terms

Conditions

Postthrombotic SyndromeVenous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesVenous Insufficiency

Study Officials

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

    Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2011

First Posted

September 7, 2011

Study Start

March 22, 2011

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

April 10, 2018

Record last verified: 2018-03

Locations

NL(12)IT(2)