The Ideal Deep Venous Thrombosis (DVT) Study (IDEAL)
This study is currently recruiting participants.
Verified October 2012 by Maastricht University Medical Center
Sponsor:
Maastricht University Medical Center
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
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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
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:
|
Phlebitis Postthrombotic Syndrome Postphlebitic Syndrome Thrombosis Venous Thrombosis Venous Thromboembolism |
Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Venous Insufficiency Peripheral Vascular Diseases Thromboembolism |
ClinicalTrials.gov processed this record on June 18, 2013