The Ideal Deep Venous Thrombosis (DVT) Study (IDEAL)
2018年4月9日 更新者：Maastricht University Medical Center
Individually Tailored Elastic Compression Therapy After Deep Venous Thrombosis in Relation to the Incidence of Post Thrombotic Syndrome, a Randomized Multicenter Trial
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.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
865
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Padua、意大利、35128
- Azienda Ospedaliera di Padova
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Treviso、意大利
- Treviso Aziende
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Almere、荷兰、1315 RA
- FlevoHospital
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Amsterdam、荷兰、1066 EC
- Slotervaart Hospital
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Amsterdam、荷兰、1105 AZ
- AMC
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Amsterdam、荷兰、1091 AC
- OLVG
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Amsterdam、荷兰、1007 MB
- VU Medical Centre
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Eindhoven、荷兰、5631 BM
- Maxima Medical Centre
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Groningen、荷兰、9713 GZ
- UMCG
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Heerlen、荷兰、6419 PC
- Atrium Medical Centre
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Hoorn、荷兰、1091 AC
- Westfriesgasthuis
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Maastricht、荷兰、6202 AZ
- Maastricht University Medical Centre
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Nijmegen、荷兰、6525 GA
- UMC Nijmegen Radboud
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Roermond、荷兰、6043 CV
- Laurentius ziekenhuis
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
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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
其他名称：
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有源比较器：Control: ECS 24 months
Elastic compression therapy with a standard duration of 24 months
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Elastic compression therapy with a standard duration of 24 months
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The occurrence of PTS at 24 months after the event of acute DVT
大体时间：At 24 months after the event of the acute DVT
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At 24 months after the event of the acute DVT
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Health Related Quality of Life (HRQOL)
大体时间：Baseline, 3, 6, 12 and 24 months
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HRQOL, will be measured by questionnaires SF-36, EuroQol-5D, Veines-Qol Dutch translated
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Baseline, 3, 6, 12 and 24 months
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Recurrent venous thrombosis
大体时间：24 months
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24 months
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Mortality due to venous thrombosis
大体时间：24 months
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24 months
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Costs
大体时间：3, 6, 12, 24 months
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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
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3, 6, 12, 24 months
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Patient Preferences
大体时间：baseline, 24 months
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Patient preferences will be elicited by conducting a discrete choice experiment (DCE)
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baseline, 24 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Arina J ten Cate-Hoek, MD, PhD, MpH、Maastricht University Medical Centre
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年3月22日
初级完成 (实际的)
2017年7月1日
研究完成 (实际的)
2017年7月1日
研究注册日期
首次提交
2011年8月24日
首先提交符合 QC 标准的
2011年9月6日
首次发布 (估计)
2011年9月7日
研究记录更新
最后更新发布 (实际的)
2018年4月10日
上次提交的符合 QC 标准的更新
2018年4月9日
最后验证
2018年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.