The Ideal Deep Venous Thrombosis (DVT) Study (IDEAL)

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.

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.

Study Overview

• Status: Completed
• Conditions: Postthrombotic Syndrome
• Intervention / Treatment: Device: Individually tailored duration of elastic compression therapy; Device: Elastic compression therapy with a standard duration of 24 months

• Study Type: Interventional
• Enrollment (Actual): 865
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Padua, Italy, 35128
    • Azienda Ospedaliera di Padova
  • Treviso, Italy
    • Treviso Aziende
• Netherlands
  • Almere, Netherlands, 1315 RA
    • FlevoHospital
  • Amsterdam, Netherlands, 1066 EC
    • Slotervaart Hospital
  • Amsterdam, Netherlands, 1105 AZ
    • AMC
  • Amsterdam, Netherlands, 1091 AC
    • OLVG
  • Amsterdam, Netherlands, 1007 MB
    • VU Medical Centre
  • Eindhoven, Netherlands, 5631 BM
    • Maxima Medical Centre
  • Groningen, Netherlands, 9713 GZ
    • UMCG
  • Heerlen, Netherlands, 6419 PC
    • Atrium Medical Centre
  • Hoorn, Netherlands, 1091 AC
    • Westfriesgasthuis
  • Maastricht, Netherlands, 6202 AZ
    • Maastricht University Medical Centre
  • Nijmegen, Netherlands, 6525 GA
    • UMC Nijmegen Radboud
  • Roermond, Netherlands, 6043 CV
    • Laurentius Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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; Other Names: Custom made flat knitted, knee length, class III stockings (Mediven ®550, ankle pressure 40 mmHg)
Active Comparator: Control: ECS 24 months; Elastic compression therapy with a standard duration of 24 months	Device: Elastic compression therapy with a standard duration of 24 months; Elastic compression therapy with a standard duration of 24 months; Other Names: Custom made flat knitted, knee length, class III stockings (Mediven ®550, ankle pressure 40 mmHg)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Arina J ten Cate-Hoek, MD, PhD, MpH, Maastricht University Medical Centre

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 22, 2011
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: August 24, 2011
• First Submitted That Met QC Criteria: September 6, 2011
• First Posted (Estimate): September 7, 2011

Study Record Updates

• Last Update Posted (Actual): April 10, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Post Thrombotic Syndrome; Deep Venous Thrombosis; Elastic Compression Stockings
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Embolism and Thrombosis; Peripheral Vascular Diseases; Venous Insufficiency; Phlebitis; Syndrome; Thrombosis; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Oxymetazoline
• Other Study ID Numbers: 10-2-026; 80-82310-97-11017 (Other Grant/Funding Number: ZonMw)