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  • 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)

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Cardiovascular medicine
Protocol
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)
  1. Christine Baumgartner1,
  2. Frederikus A Klok2,
  3. Marc Carrier3,
  4. Andreas Limacher4,
  5. Jeanne Moor1,
  6. Marc Righini5,
  7. Jürg-Hans Beer6,
  8. Martina Peluso1,
  9. Damiana Rakovic1,
  10. Menno V Huisman2,
  11. Drahomir Aujesky1
  1. 1Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
  2. 2Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands
  3. 3Department of Medicine, The Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, Ontario, Canada
  4. 4CTU Bern, University of Bern, Bern, Switzerland
  5. 5Division of Angiology and Haemostasis, Geneva University Hospital, University of Geneva, Geneva, Switzerland
  6. 6Department of Internal Medicine, Cantonal Hospital of Baden, Baden, Switzerland
  1. Correspondence to Dr Christine Baumgartner; Christine.Baumgartner{at}insel.ch

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 NCT04263038.

  • subsegmental pulmonary embolism
  • anticoagulation
  • randomised clinical trialx
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2020-040151

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    Footnotes

    • Contributors Study concept and design: DA, MVH, MC, FAK, J-HB, MR, AL, CB. Drafting of the manuscript: CB, DA. Critical revision of the manuscript for important intellectual content: MVH, MC, FAK, JHB, MR, AL, JM, MP, DR. Statistical analysis plan: AL. Obtained funding: DA, MR, J-HB. Administrative, technical or material support: MP, JM, DR, CB. Supervision: DA.

    • Funding This study is supported by an Investigator Initiated Clinical Trials (IICT) grant of the Swiss National Science Foundation (SNSF 33IC30_185616). The study medication was provided free of charge by Bayer AG.

    • Competing interests MC reports grants from Leo Pharma, BMS, Pfizer, personal fees from Bayer, BMS, Pfizer, Sanofi, Leo Pharma, Servier, outside the submitted work. All other authors declare that they have no competing interest with regard to the intellectual concern and proprietary of affairs. The funding source had no role in the design of this study and does not have any role in the conduct, the collection, management, analysis and interpretation of the data, the writing of the manuscript or the decision to submit the results for publication.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.