The Ideal Deep Venous Thrombosis (DVT) Study

Postthrombotic Syndrome Clinical Trial

— IDEAL  

Official title:

Individually Tailored Elastic Compression Therapy After Deep Venous Thrombosis in Relation to the Incidence of Post Thrombotic Syndrome, a Randomized Multicenter Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429714
• Other study ID #: 10-2-026
• Secondary ID: 80-82310-97-1101
• Status: Completed
• Phase: N/A
• First received: August 24, 2011
• Last updated: April 9, 2018
• Start date: March 22, 2011
• Est. completion date: July 1, 2017

Study information

• Verified date: March 2018
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 865
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Syndrome
• Thrombosis
• Venous Thrombosis

Intervention

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
• Elastic compression therapy with a standard duration of 24 months
Elastic compression therapy with a standard duration of 24 months

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera di Padova	Padua
Italy	Treviso Aziende	Treviso
Netherlands	Flevohospital	Almere
Netherlands	AMC	Amsterdam
Netherlands	OLVG	Amsterdam
Netherlands	Slotervaart hospital	Amsterdam
Netherlands	VU Medical Centre	Amsterdam
Netherlands	Maxima Medical Centre	Eindhoven
Netherlands	UMCG	Groningen
Netherlands	Atrium Medical Centre	Heerlen
Netherlands	Westfriesgasthuis	Hoorn
Netherlands	Maastricht University Medical Centre	Maastricht
Netherlands	UMC Nijmegen Radboud	Nijmegen
Netherlands	Laurentius ziekenhuis	Roermond

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Countries where clinical trial is conducted

Italy,  Netherlands, 

References & Publications (2)

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, Serné 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of PTS at 24 months after the event of acute DVT		At 24 months after the event of the acute DVT
Secondary	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
Secondary	Recurrent venous thrombosis		24 months
Secondary	Mortality due to venous thrombosis		24 months
Secondary	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
Secondary	Patient Preferences	Patient preferences will be elicited by conducting a discrete choice experiment (DCE)	baseline, 24 months