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Title

Clinical Surveillance vs. Anticoagulation For low-risk patiEnts with isolated SubSegmental Pulmonary Embolism: protocol for a multicentre randomised placebo-controlled non-inferiority trial (SAFE-SSPE)

Authors
Baumgartner, Christine
Klok, Frederikus A
Carrier, Marc
Limacher, Andreas
Moor, Jeanne
Beer, Jürg-Hans
Peluso, Martina
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Published in BMJ open. 2020, vol. 10, no. 11, e040151
Abstract

Introduction: The 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 analysis: SAFE-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 dissemination: The 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 number: <a href="http://clinicaltrials.gov/show/NCT04263038" rel="noopener noreferrer" target="_blank">NCT04263038</a>.

Keywords AnticoagulationRandomised clinical trialxSubsegmental pulmonary embolismAdultAnticoagulants / adverse effectsCanadaDouble-Blind MethodHumansNetherlandsPulmonary Embolism / drug therapyQuality of LifeRandomized Controlled Trials as TopicSwitzerlandVenous Thromboembolism / drug therapyVenous Thromboembolism / prevention & control
Identifiers
PMID: 33444199
PMCID: PMC7678381
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Structures
Research group La maladie thromboembolique veineuse (808)
Project
Swiss National Science Foundation: 33IC30_185616
Citation
(ISO format)
BAUMGARTNER, Christine et al. Clinical Surveillance vs. Anticoagulation For low-risk patiEnts with isolated SubSegmental Pulmonary Embolism: protocol for a multicentre randomised placebo-controlled non-inferiority trial (SAFE-SSPE). In: BMJ open, 2020, vol. 10, n° 11, p. e040151. doi: 10.1136/bmjopen-2020-040151 https://archive-ouverte.unige.ch/unige:161628

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Deposited on : 2022-06-22

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