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

Abstract

IntroductionPost-thrombotic syndrome (PTS) is a serious complication of deep vein thrombosis (DVT) of the leg that affects 20–50% of patients. Once a patient experiences PTS there is no treatment that effectively reduces the debilitating complaints. Two randomised controlled trials showed that elastic compression stocking (ECS) therapy after DVT for 24 months can reduce the incidence of PTS by 50%. However, it is unclear whether all patients benefit to the same extent from ECS therapy or what the optimal duration of therapy for individual patients should be. ECS therapy is costly, inconvenient, demanding and sometimes even debilitating. Tailoring therapy to individual needs could save substantial costs. The objective of the IDEAL DVT study, therefore, is to evaluate whether tailoring the duration of ECS therapy on signs and symptoms of the individual patient is a safe and effective method to prevent PTS, compared with standard ECS therapy.Methods and analysisA multicentre, single-blinded, allocation concealed, randomised, non-inferiority trial. A total of 864 consecutive patients with acute objectively documented proximal DVT of the leg are randomised to either standard duration of 24 months or tailored duration of ECS therapy following an initial therapeutic period of 6 months. Signs and symptoms of PTS are recorded at regular clinic visits. Furthermore, quality of life, costs, patient preferences and compliance are measured. The primary outcome is the proportion of patients with PTS at 24 months.Ethics and disseminationBased on current knowledge the standard application of ECS therapy is questioned. The IDEAL DVT study will address the central questions that remain unanswered: Which individual patients benefit from ECS therapy and what is the optimal individual treatment duration? Primary ethics approval was received from the Maastricht University Medical Centre.ResultsResults of the study will be disseminated via peer-reviewed publications and presentations at scientific conferences.Trial registration numberNCT01429714 and NTR 2597.

Prevention and treatment of the post‐thrombotic syndrome

“…Based on these findings, a randomized non‐inferiority trial was designed. This trial investigated whether the main therapeutic effect of individualized ECS therapy following initial 6 months of ECS therapy would not be unacceptably different from that of standard duration of therapy, and whether the accepted loss of efficacy of the new therapy would be balanced by a reduction in costs and or an increase in HRQoL . The upper margin of the loss of efficacy that was deemed to be acceptable was set at 7.5% (the noninferiority margin) …”

Eliciting patients' preferences for elastic compression stocking therapy after deep vein thrombosis: potential for improving compliance

“…Whether a shorter duration of ECS therapy provides the same benefits for the prevention of PTS still needs to be established. The final results of the IDEAL DVT study will have to be awaited to ensure the safety of individually tailored duration of ECS therapy and its eventual effect on compliance in the long term .…”

“…The medical ethical committee of the Maastricht University Medical Centre approved this study, and all patients gave written informed consent. Consecutive patients with proximal DVT are being included in the IDEAL DVT study . In September 2013 the DCE survey was implemented in the study.…”

Changing paradigms in the management of deep vein thrombosis

“…The ongoing IDEAL study will investigate whether tailoring compression stocking therapy to individual patients and symptoms would save costs and select for the most appropriate patients who would derive benefit. Results are expected in 2017 (Ten Cate‐Hoek et al , ). Pharmacological therapies for PTS have been explored, however a 2013 Cochrane review found a lack of placebo‐controlled trials in support of rutosides (Morling et al , ), compounds derived from horse chestnut and claimed as herbal remedies for the management of oedema and symptomatology in chronic venous disease.…”