scholarly journals MUFFIN-PTS trial, Micronized Purified Flavonoid Fraction for the Treatment of Post-Thrombotic Syndrome: protocol of a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e049557
Author(s):  
Jean Philippe Galanaud ◽  
Jameel Abdulrehman ◽  
A Lazo-Langner ◽  
Grégoire Le Gal ◽  
Sudeep Shivakumar ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Compression Stockings ◽  
Level Of Evidence ◽  
Vein Thrombosis ◽  
Post Thrombotic Syndrome ◽  
Registration Number ◽  
Venoactive Drugs ◽  
Micronized Purified Flavonoid Fraction ◽  
Flavonoid Fraction ◽  
Randomised Controlled

IntroductionAfter 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 analysisThe 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 disseminationPrimary 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 numberClinicalTrials.gov Registry (NCT03833024); Pre-results.

scholarly journals Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168)

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e044285
Author(s):  
Ankur Thapar ◽  
Rebecca Lawton ◽  
Laura Burgess ◽  
Joseph Shalhoub ◽  
Andrew Bradbury ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Randomised Trial ◽  
Standard Of Care ◽  
Compression Stockings ◽  
Vein Thrombosis ◽  
Post Thrombotic Syndrome ◽  
Score Analysis ◽  
Registration Number ◽  
Randomised Controlled ◽  
Deep Vein

IntroductionUp to 50% of patients develop post-thrombotic syndrome (PTS) after an above knee deep vein thrombosis (DVT). The aim of the study was to determine the effect of graduated compression stockings in preventing PTS after DVT.Methods and analysisPragmatic, UK multicentre randomised trial in adults with first above knee DVT. The standard of care arm is anticoagulation. The intervention arm will receive anticoagulation plus stockings (European class II, 23–32 mm Hg compression) worn for a median of 18 months. The primary endpoint is PTS using the Villalta score. Analysis of this will be through a time to event approach and cumulative incidence at median 6, 12 and 18 months. An ongoing process evaluation will examine factors contributing to adherence to stockings to understand if and how the behavioural interventions were effective.Ethics and disseminationUK research ethics committee approval (reference 19/LO/1585). Dissemination though the charity Thrombosis UK, the Imperial College London website, peer-reviewed publications and international conferences.Trial registration numberISRCTN registration number 73041168.

Review on the value of graduated elastic compression stockings after deep vein thrombosis

2006 ◽  
Vol 96 (10) ◽  
pp. 441-445 ◽  
Author(s):  
Stavros Kakkos ◽  
Stella Daskalopoulou ◽  
Marios Daskalopoulos ◽  
Andrew Nicolaides ◽  
George Geroulakos
Keyword(s):  
Deep Vein Thrombosis ◽  
Preventive Measures ◽  
Number Needed To Treat ◽  
Compression Stockings ◽  
Elastic Compression ◽  
Vein Thrombosis ◽  
Post Thrombotic Syndrome ◽  
Randomised Controlled ◽  
Deep Vein

SummaryGraduated elastic compression stockings (GECS) are commonly used in the primary prevention of deep vein thrombosis (DVT); however, their role in preventing recurrent DVT and also post-thrombotic syndrome is less well established. The aim of this review was to investigate the effect of GECS after DVT. A literature search was performed by two independent searchers in order to identify randomised controlled trials on the effect of GECS in preventing recurrent DVT and post-thrombotic syndrome. Four randomised trials, including 537 patients, were identified. Two of the studies demonstrated that below-knee GECS significantly reduced post-thrombotic syndrome during follow-up, while a smaller study showed equivocal results. GECS reduced the incidence of post-thrombotic syndrome from 54% to 25.2% [relative risk (RR) 0.47, 95% confidence interval (CI) 0.36-0.61] with the number needed to treat (NNT) being 4 (95% CI 2.7-5.0).The rate of recurrent asymptomatic DVT was also significantly reduced by GECS (RR 0.20, 95% CI 0.06-0.64; NNT 5); the reduction in symptomatic DVT was not significant (RR 0.79, 95% CI 0.50-1.26; NNT 34). In conclusion, there is level Ia evidence to suggest that GECS can significantly reduce the incidence of post-thrombotic syndrome (PTS) after DVT, and therefore these should be routinely prescribed. The evidence for recurrent DVT is less conclusive. Further research is needed towards standardising PTS diagnostic criteria and evaluating more effective preventive measures after DVT.

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