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

• Published in: BMJ open Vol. 4; no. 9; p. e005265
• Main Authors: ten Cate-Hoek, Arina J, Bouman, Annemieke C, Joore, Manuela A, Prins, Martin, ten Cate, Hugo
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 04.09.2014; BMJ Publishing Group
• Subjects: Cardiovascular Medicine; Compliance; Compression therapy; Cost analysis; Humans; Patients; Postthrombotic Syndrome - etiology; Postthrombotic Syndrome - prevention & control; Precision Medicine; Prevention; Quality of life; Single-Blind Method; Stockings, Compression; Thrombosis; Time Factors; Venous Thrombosis - complications; Netherlands; Deep vein thrombosis; Elastic compression stocking therapy; RCT; Post thrombotic syndrome; Protocol
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2014-005265

Introduction Post-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 analysis A 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 dissemination Based 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. Results Results of the study will be disseminated via peer-reviewed publications and presentations at scientific conferences. Trial registration number NCT01429714 and NTR 2597.