Clinical trial NCT01429714: The Ideal Deep Venous Thrombosis (DVT) Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postthrombotic Syndrome
Keywords: Elastic Compression Stockings
Deep Venous Thrombosis
Post Thrombotic Syndrome
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2011-09-07
Enrollment: 865
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: The occurrence of PTS at 24 months after the event of acute DVT
timeFrame: At 24 months after the event of the acute DVT
Secondary outcomes:
measure: Health Related Quality of Life (HRQOL)
timeFrame: Baseline, 3, 6, 12 and 24 months
measure: Recurrent venous thrombosis
timeFrame: 24 months
measure: Mortality due to venous thrombosis
timeFrame: 24 months
measure: Costs
timeFrame: 3, 6, 12, 24 months
measure: Patient Preferences
timeFrame: baseline, 24 months
Other outcomes:
Locations:
city: Padua
country: Italy
facility: Azienda Ospedaliera di Padova
city: Treviso
country: Italy
facility: Treviso Aziende
city: Almere
country: Netherlands
facility: Flevohospital
city: Amsterdam
country: Netherlands
facility: VU Medical Centre
city: Amsterdam
country: Netherlands
facility: Slotervaart hospital
city: Amsterdam
country: Netherlands
facility: OLVG
city: Amsterdam
country: Netherlands
facility: AMC
city: Eindhoven
country: Netherlands
facility: Maxima Medical Centre
city: Groningen
country: Netherlands
facility: UMCG
city: Heerlen
country: Netherlands
facility: Atrium Medical Centre
city: Hoorn
country: Netherlands
facility: Westfriesgasthuis
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
city: Nijmegen
country: Netherlands
facility: UMC Nijmegen Radboud
city: Roermond
country: Netherlands
facility: Laurentius ziekenhuis
Study officials:
affiliation: Maastricht University Medical Centre
name: Arina J ten Cate-Hoek, MD, PhD, MpH
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.