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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Maastricht University Medical Center
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01429714
First received: August 24, 2011
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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 Intervention
Postthrombotic Syndrome
Device: Individually tailored duration of elastic compression therapy
Device: Elastic compression therapy with a standard duration of 24 months

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health Related Quality of Life (HRQOL) [ Time Frame: Baseline, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    HRQOL, will be measured by questionnaires SF-36, EuroQol-5D, Veines-Qol Dutch translated

  • Recurrent venous thrombosis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Mortality due to venous thrombosis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Costs [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
    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

  • Patient Preferences [ Time Frame: baseline, 24 months ] [ Designated as safety issue: No ]
    Patient preferences will be elicited by conducting a discrete choice experiment (DCE)


Estimated Enrollment: 847
Study Start Date: March 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429714

Contacts
Contact: Arina J ten Cate-Hoek, MD, PhD, MpH 0031-(0)43-3873124 arina.tencate@epid.unimaas.nl
Contact: Annemieke C Bouman, MD 0031-(0)43-3874389 annemiek.bouman@mumc.nl

Locations
Italy
Azienda Ospedaliera di Padova Recruiting
Padua, Italy, 35128
Contact: P Prandoni, Prof, MD    0039 (0)49 8212659    paoloprandoni@tin.it   
Principal Investigator: P Prandoni, Prof, MD         
Treviso Aziende Recruiting
Treviso, Italy
Contact: S Villalta, MD       svillalta@ulss.tv.it   
Principal Investigator: S Villalta, MD         
Netherlands
Flevohospital Recruiting
Almere, Netherlands, 1315 RA
Contact: M ten Wolde, MD, PhD    0031(0)36 5279 224    mtenwolde@flevoziekenhuis.nl   
Principal Investigator: M ten Wolde, MD, PhD         
OLVG Recruiting
Amsterdam, Netherlands, 1091 AC
Contact: S van Wissen, MD, PhD    0031 (0)20 5993172    s.vanwissen@olvg.nl   
Principal Investigator: S van Wissen, MD, PhD         
Slotervaart hospital Recruiting
Amsterdam, Netherlands, 1066 EC
Contact: J MMB Otten, MD, PhD    0031 (0)20 5125110    Hans-martin.otten@slz.nl   
Principal Investigator: J MMB Otten, MD, PhD         
AMC Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: M Coppens, MD, PhD    0031 (0)20 5666637    M.Coppens@amc.uva.nl   
Principal Investigator: M Coppens, MD, PhD         
VU Medical Centre Recruiting
Amsterdam, Netherlands, 1007 MB
Contact: H MA Hofstee, MD    +31 20 4444307    hma.hofstee@vumc.nl   
Principal Investigator: H MA Hofstee, MD         
Maxima Medical Centre Recruiting
Eindhoven, Netherlands, 5631 BM
Contact: L W Tick, MD, PhD    0031 (0)40 8886154    l.tick@mmc.nl   
Principal Investigator: L W Tick, MD, PhD         
UMCG Recruiting
Groningen, Netherlands, 9713 GZ
Contact: K Meijer, MD, PhD    0031 (0)50 3610260    k.meijer@int.umcg.nl   
Principal Investigator: K Meijer, MD, PhD         
Atrium Medical Centre Recruiting
Heerlen, Netherlands, 6419 PC
Contact: G Jie, MD, PhD    0031 (0)45 5766578    g.jie@atriummc.nl   
Principal Investigator: G Jie, MD, PhD         
Westfriesgasthuis Recruiting
Hoorn, Netherlands, 1091 AC
Contact: S M van den Heiligenberg, MD    0031 (0)22 9257902    s.m.vandenHeiligenberg@westfriesgasthuis.nl   
Principal Investigator: S M van den Heiligenberg, MD         
Maastricht University Medical Centre Recruiting
Maastricht, Netherlands, 6202 AZ
Contact: A J ten Cate-Hoek, MD, PhD, MpH    0031 (0)43 3873124    arina.tencate@epid.unimaas.nl   
Contact: A C Bouman, MD    0031 (0)43 3874389    annemiek.bouman@mumc.nl   
Principal Investigator: A J ten Cate-Hoek, MD, PhD, MpH         
UMC Nijmegen Radboud Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: M CH Janssen, MD, PhD    0031 (0)24 3616504    m.janssen@aig.umcn.nl   
Principal Investigator: M CH Janssen, MD, PhD         
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
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01429714     History of Changes
Other Study ID Numbers: 10-2-026, 80-82310-97-11017
Study First Received: August 24, 2011
Last Updated: October 24, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on August 20, 2014