Compression therapy for prevention of post-thrombotic syndrome.
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ABSTRACT:
SUBMITTER: Appelen D
PROVIDER: S-EPMC6483721 | biostudies-literature | 2017 Sep
REPOSITORIES: biostudies-literature
Publications
Compression therapy for prevention of post-thrombotic syndrome.
Appelen Diebrecht D van Loo Eva E Prins Martin H MH Neumann Martino Ham MH Kolbach Dinanda N DN
The Cochrane database of systematic reviews 20170926
<h4>Background</h4>Post-thrombotic syndrome (PTS) is a long-term complication of deep vein thrombosis (DVT) that is characterised by chronic pain, swelling, and skin changes in the affected limb. One of every three people with DVT will develop post-thrombotic complications within five years. Several non-pharmaceutical measures are used for prevention of post-thrombotic syndrome during the acute phase of DVT. These include elevation of the legs and compression therapy. Clinicians and guidelines d ...[more]
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Project description: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.
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