Résumé
Introduction After deep vein thrombosis, up to 50% of patients develop post-thrombotic syndrome (PTS). PTS is a chronic condition that reduces quality of life (QOL). Cornerstones of PTS treatment include the use of elastic compression stockings but this treatment is usually incompletely effective and is burdensome. Venoactive drugs have been reported to be effective to treat chronic venous insufficiency (CVI). However, the level of evidence supporting their use in CVI in general and in PTS in particular is low. Methods and analysis The MUFFIN-PTS trial is an academic, publically funded, multicentre randomised placebo-controlled trial assessing the efficacy of micronised purified flavonoid fraction (MPFF, Venixxa), a venoactive drug, to treat PTS. Eighty-six patients with PTS (Villalta score (VS) ≥5) and experiencing at least two of the following PTS manifestations among daily leg heaviness, cramps, pain or oedema will be randomised to receive 1000 mg of oral MPFF or a similar appearing placebo for 6 months, in addition to their usual PTS treatment. Total study follow-up will be 9 months, with visits at inclusion/baseline, 3, 6 and 9 months. Primary outcome is the proportion of patients with improvement in VS in each group, where improvement is defined as a decrease of at least 30% in VS or a VS <5 in the PTS-affected leg. Main secondary outcomes include QOL and patient satisfaction. Ethics and dissemination Primary ethics approval was received from Centre intégré universitaire de santé et de services sociaux (CIUSSS) West-Central Montreal Research Ethics Board. Results of the study will be disseminated via peer-reviewed publications and presentations at scientific conferences. Trial registration number ClinicalTrials.gov Registry (NCT03833024); Pre-results.
| Langue d'origine | English |
|---|---|
| Numéro d'article | e049557 |
| Journal | BMJ Open |
| Volume | 11 |
| Numéro de publication | 9 |
| DOI | |
| Statut de publication | Published - sept. 13 2021 |
Note bibliographique
Funding Information:Funding This work is supported by a grant from the Canadian Institute of Health
Funding Information:
The MUFFIN-PTS trial is funded by a grant from the CIHR (#332593). The study protocol was approved by Biomedical Research Ethics Committee of Centre intégré universitaire de santé et de services sociaux (CIUSSS) West-Central Montreal Research Ethics Board on 29 June 2020 (Project 2019-1656). Written informed consent will be obtained from all participating patients and consent form is provided as an online supplemental file. The MUFFIN-PTS trial is expected to begin enrolling patients in 2021. Results of the study will be disseminated via peer-reviewed publications and presentations at scientific conferences. Open access to individual patient data is not planned, but all requests for the trial’s data will be considered on an individual basis by the trial steering committee.
Funding Information:
1Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada 2Medicine, University Health Network, Toronto, Ontario, Canada 3Medicine, Western University, London, Ontario, Canada 4Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada 5Medicine, Dalhousie University, Halifax, Nova Scotia, Canada 6Medicine, McMaster University, Hamilton, Ontario, Canada 7Medicine, McGill University, Montreal, Quebec, Canada Acknowledgements SK is a Tier 1 Canada Research Chair holder. All investigators are members of the CanVECTOR Network, which receives grant funding from the Canadian Institutes of Health Research (Funding Reference: CDT-142654).
Publisher Copyright:
© 2021 BMJ Publishing Group. All rights reserved.
ASJC Scopus Subject Areas
- General Medicine
PubMed: MeSH publication types
- Clinical Trial Protocol
- Journal Article
- Research Support, Non-U.S. Gov't