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| ID | Type | Description | Link |
|---|---|---|---|
| 80-82310-97-11017 | Other Grant/Funding Number | ZonMw |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: individually tailored ECS | Experimental | 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. |
|
| Control: ECS 24 months | Active Comparator | Elastic compression therapy with a standard duration of 24 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individually tailored duration of elastic compression therapy | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of PTS at 24 months after the event of acute DVT | At 24 months after the event of the acute DVT |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Recurrent venous thrombosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arina J ten Cate-Hoek, MD, PhD, MpH | Maastricht University Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera di Padova | Padua | 35128 | Italy | |||
| Treviso Aziende |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25190617 | Background | 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. | |
| 29217387 |
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|
| Elastic compression therapy with a standard duration of 24 months | Device | Elastic compression therapy with a standard duration of 24 months |
|
|
| 24 months |
| Mortality due to venous thrombosis | 24 months |
| 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 |
| Patient Preferences | Patient preferences will be elicited by conducting a discrete choice experiment (DCE) | baseline, 24 months |
| Treviso |
| Italy |
| Flevohospital | Almere Stad | 1315 RA | Netherlands |
| VU Medical Centre | Amsterdam | 1007 MB | Netherlands |
| Slotervaart hospital | Amsterdam | 1066 EC | Netherlands |
| OLVG | Amsterdam | 1091 AC | Netherlands |
| AMC | Amsterdam | 1105 AZ | Netherlands |
| Maxima Medical Centre | Eindhoven | 5631 BM | Netherlands |
| UMCG | Groningen | 9713 GZ | Netherlands |
| Atrium Medical Centre | Heerlen | 6419 PC | Netherlands |
| Westfriesgasthuis | Hoorn | 1091 AC | Netherlands |
| Maastricht University Medical Centre | Maastricht | 6202 AZ | Netherlands |
| UMC Nijmegen Radboud | Nijmegen | 6525 GA | Netherlands |
| Laurentius ziekenhuis | Roermond | 6043 CV | Netherlands |
| 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. |
| 40086064 | Derived | Iding AFJ, Ten Cate V, Ten Cate H, Wild PS, Ten Cate-Hoek AJ. Untangling profiles of postthrombotic syndrome using unsupervised machine learning. Blood Adv. 2025 Jul 22;9(14):3631-3641. doi: 10.1182/bloodadvances.2025015829. |
| 30314712 | Derived | 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. |
| 30237155 | Derived | 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. |
| 29856509 | Derived | 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. |
| ID | Term |
|---|---|
| D054070 | Postthrombotic Syndrome |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014689 | Venous Insufficiency |
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