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

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ClinicalTrials.gov Identifier: NCT01429714
Recruitment Status : Completed
First Posted : September 7, 2011
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

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.


Condition or disease Intervention/treatment Phase
Postthrombotic Syndrome Device: Individually tailored duration of elastic compression therapy Device: Elastic compression therapy with a standard duration of 24 months Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 865 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Individually Tailored Elastic Compression Therapy After Deep Venous Thrombosis in Relation to the Incidence of Post Thrombotic Syndrome, a Randomized Multicenter Trial
Study Start Date : March 22, 2011
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Health Related Quality of Life (HRQOL) [ Time Frame: Baseline, 3, 6, 12 and 24 months ]
    HRQOL, will be measured by questionnaires SF-36, EuroQol-5D, Veines-Qol Dutch translated

  2. Recurrent venous thrombosis [ Time Frame: 24 months ]
  3. Mortality due to venous thrombosis [ Time Frame: 24 months ]
  4. Costs [ Time Frame: 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

  5. Patient Preferences [ Time Frame: baseline, 24 months ]
    Patient preferences will be elicited by conducting a discrete choice experiment (DCE)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429714


Locations
Italy
Azienda Ospedaliera di Padova
Padua, Italy, 35128
Treviso Aziende
Treviso, Italy
Netherlands
Flevohospital
Almere, Netherlands, 1315 RA
VU Medical Centre
Amsterdam, Netherlands, 1007 MB
Slotervaart hospital
Amsterdam, Netherlands, 1066 EC
OLVG
Amsterdam, Netherlands, 1091 AC
AMC
Amsterdam, Netherlands, 1105 AZ
Maxima Medical Centre
Eindhoven, Netherlands, 5631 BM
UMCG
Groningen, Netherlands, 9713 GZ
Atrium Medical Centre
Heerlen, Netherlands, 6419 PC
Westfriesgasthuis
Hoorn, Netherlands, 1091 AC
Maastricht University Medical Centre
Maastricht, Netherlands, 6202 AZ
UMC Nijmegen Radboud
Nijmegen, Netherlands, 6525 GA
Laurentius ziekenhuis
Roermond, Netherlands, 6043 CV
Sponsors and Collaborators
Maastricht University Medical Center
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:
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01429714     History of Changes
Other Study ID Numbers: 10-2-026
80-82310-97-11017 ( Other Grant/Funding Number: ZonMw )
First Posted: September 7, 2011    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: March 2018

Keywords provided by Maastricht University Medical Center:
Elastic Compression Stockings
Deep Venous Thrombosis
Post Thrombotic Syndrome

Additional relevant MeSH terms:
Syndrome
Thrombosis
Venous Thrombosis
Postthrombotic Syndrome
Postphlebitic Syndrome
Disease
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases