scholarly journals Thromboembolic risk stratification by TRiP(cast) score to rationalise thromboprophylaxis in patients with lower leg trauma requiring immobilisation: a study protocol of the casting stepped-wedge cluster randomised trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e045905
Author(s):  
Delphine Douillet ◽  
Jeremie Riou ◽  
Maximilien Thoma ◽  
Thomas Moumneh ◽  
Astrid Darsonval ◽  
...  

IntroductionPatients with lower limb trauma requiring orthopaedic immobilisation may be at risk of venous thromboembolism but opinions differ about who may benefit from thromboprophylactic anticoagulant treatment.The aim of this CASTING study is to demonstrate the safety of thromboprophylaxis based on the Thrombosis Risk Prediction for patients with cast immobilisation (TRiP(cast) score with regards to the 3-month incidence of symptomatic venous thromboembolism events in low-risk patients not receiving thromboprophylaxis, as well as the usefulness of this strategy on the rate of patients receiving anticoagulant treatment in comparison to current practice.Methods and analysisCASTING will be a stepped-wedge cluster randomised controlled clinical trial, performed in 15 emergency departments in France and Belgium. With their informed consent, outpatients admitted to one of the participating emergency departments for a lower limb trauma requiring orthopaedic immobilisation without surgery will be included. All centres will begin the trial with the ‘observational period’ and, every 2 weeks, 1 centre will be randomly assigned to switch to the ‘interventional period’ and to apply the TRiP(cast) score, in which only patients with a score ≥7 will receive thromboprophylactic anticoagulant treatment. The primary endpoint is the rate of clinical thromboembolic events within 90 days following the inclusion of low-risk patients not receiving thromboprophylaxis.Ethics and disseminationThe protocol has been approved by the Comité de Protection des Personnes Sud I (Ethics Review ID-RCB: 2019-A01829-48) for France and the Comité d’éthique hôpital-facultaire Saint Luc (N° B403201941338) for Belgium. It is carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. The findings of this study will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration numberNCT04064489.

2020 ◽  
Vol 20 ◽  
pp. 100270 ◽  
Author(s):  
Banne Nemeth ◽  
Delphine Douillet ◽  
Saskia le Cessie ◽  
Andrea Penaloza ◽  
Thomas Moumneh ◽  
...  

2008 ◽  
Vol 6 (2) ◽  
pp. 134-142 ◽  
Author(s):  
Nikolaos Kanakaris ◽  
Vassilios Nikolaou ◽  
Theodoros Tosounidis ◽  
Peter Giannoudis

PLoS ONE ◽  
2019 ◽  
Vol 14 (6) ◽  
pp. e0217748 ◽  
Author(s):  
D. Douillet ◽  
B. Nemeth ◽  
A. Penaloza ◽  
G. Le Gal ◽  
T. Moumneh ◽  
...  

2018 ◽  
Vol 34 (5) ◽  
pp. 291-293
Author(s):  
Benjamin J Langridge ◽  
Richard J Goodall ◽  
Sarah Onida ◽  
Joseph Shalhoub ◽  
Alun H Davies

Author(s):  
Mario Cherubino ◽  
Tommaso Baroni ◽  
Luigi Valdatta

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040151
Author(s):  
Christine Baumgartner ◽  
Frederikus A Klok ◽  
Marc Carrier ◽  
Andreas Limacher ◽  
Jeanne Moor ◽  
...  

IntroductionThe clinical significance of subsegmental pulmonary embolism (SSPE) is currently unclear. Although growing evidence from observational studies suggests that withholding anticoagulant treatment may be a safe option in selected patients with isolated SSPE, most patients with this condition receive anticoagulant treatment, which is associated with a 90-day risk of recurrent venous thromboembolism (VTE) of 0.8% and major bleeding of up to 5%. Given the ongoing controversy concerning the risk-benefit ratio of anticoagulation for isolated SSPE and the lack of evidence from randomised-controlled studies, the aim of this clinical trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation in low-risk patients with isolated SSPE.Methods and analysisSAFE-SSPE (Surveillance vs. Anticoagulation For low-risk patiEnts with isolated SubSegmental Pulmonary Embolism, a multicentre randomised placebo-controlled non-inferiority trial) is an international, multicentre, placebo-controlled, double-blind, parallel-group non-inferiority trial conducted in Switzerland, the Netherlands and Canada. Low-risk patients with isolated SSPE are randomised to receive clinical surveillance with either placebo (no anticoagulation) or anticoagulant treatment with rivaroxaban. All patients undergo bilateral whole-leg compression ultrasonography to exclude concomitant deep vein thrombosis before enrolment. Patients are followed for 90 days. The primary outcome is symptomatic recurrent VTE (efficacy). The secondary outcomes include clinically significant bleeding and all-cause mortality (safety). The ancillary outcomes are health-related quality of life, functional status and medical resource utilisation.Ethics and disseminationThe local ethics committees in Switzerland have approved this protocol. Submission to the Ethical Committees in the Netherlands and Canada is underway. The results of this trial will be published in a peer-reviewed journal.Trial registration numberNCT04263038.


Author(s):  
M. J. Yaremchuk ◽  
A. J. Weiland

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