Article Text

Download PDFPDF

Protocol
Examining the benefit of graduated compression stockings in the prevention of hospital-associated venous thromboembolism in low-risk surgical patients: a multicentre cluster randomised controlled trial (PETS trial)
  1. Matthew Machin1,2,
  2. Sarrah Peerbux1,
  3. Sarah Whittley1,
  4. Beverley J Hunt3,
  5. Tamara Everington4,
  6. Manjit Gohel5,
  7. John Norrie6,
  8. David Epstein7,
  9. David J Warwick8,
  10. Christopher Baker2,
  11. Zaed Hamady9,
  12. Sasha Smith1,
  13. Layla Bolton2,
  14. Annya Stephens-Boal1,
  15. Beverley Gray1,
  16. Joseph Shalhoub1,2,
  17. Alun Huw Davies1,2
  1. 1Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK
  2. 2Imperial Vascular Unit, St Mary’s Hospital, Imperial College Healthcare NHS Trust, London, UK
  3. 3Thrombosis & Haemophilia Centre, Guy’s and St Thomas’ NHS Foundation Trust, London, UK
  4. 4Hampshire Hospitals NHS Foundation Trust, Winchester, Hampshire, UK
  5. 5Department of Vascular Surgery, Addenbrooke's Hospital, Cambridge, UK
  6. 6Usher Institute of Population Health Sciences and Informatics, Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK
  7. 7Faculty of Economic and Business Sciences, University of Granada, Granada, Spain
  8. 8University Hospital Southampton NHS Foundation Trust, Southampton, UK
  9. 9General Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK
  1. Correspondence to Professor Alun Huw Davies; a.h.davies{at}imperial.ac.uk

Abstract

Introduction Hospital-acquired thrombosis (HAT) is defined as any venous thromboembolism (VTE)-related event during a hospital admission or occurring up to 90 days post discharge, and is associated with significant morbidity, mortality and healthcare-associated costs. Although surgery is an established risk factor for VTE, operations with a short hospital stay (<48 hours) and that permit early ambulation are associated with a low risk of VTE. Many patients undergoing short-stay surgical procedures and who are at low risk of VTE are treated with graduated compression stockings (GCS). However, evidence for the use of GCS in VTE prevention for this cohort is poor.

Methods and analysis A multicentre, cluster randomised controlled trial which aims to determine whether GCS are superior in comparison to no GCS in the prevention of VTE for surgical patients undergoing short-stay procedures assessed to be at low risk of VTE. A total of 50 sites (21 472 participants) will be randomised to either intervention (GCS) or control (no GCS). Adult participants (18–59 years) who undergo short-stay surgical procedures and are assessed as low risk of VTE will be included in the study. Participants will provide consent to be contacted for follow-up at 7-days and 90-days postsurgical procedure. The primary outcome is the rate of symptomatic VTE, that is, deep vein thrombosis or pulmonary embolism during admission or within 90 days. Secondary outcomes include healthcare costs and changes in quality of life. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, measured at an individual level, using hierarchical (multilevel) logistic regression.

Ethics and dissemination Ethical approval was granted by the Camden and Kings Cross Research Ethics Committee (22/LO/0390). Findings will be published in a peer-reviewed journal and presented at national and international conferences.

Trial registration number ISRCTN13908683.

  • thromboembolism
  • surgery
  • vascular medicine
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/.

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Footnotes

  • Twitter @handwrist, @sasha_kya, @ThrombosisUK

  • Collaborators Imperial College London: Professor Alun Huw Davies, Mr Joseph Shalhoub, Mr Matthew Machin, Miss Sasha Smith, Dr Christopher Baker, Ms Layla Bolton. Guy’s and St Thomas’ NHS Foundation Trust: Professor Beverley Hunt. Hampshire Hospitals NHS Foundation Trust: Dr Tamara Everington. University of Granada: Dr David Epstein. Cambridge University Hospitals NHS Foundation Trust: Mr Manjit Gohel. The University of Edinburgh: Professor John Norrie. University Hospital Southampton NHS Foundation Trust: Professor David Warwick, Mr Zaed Hamady Thrombosis UK: Ms Annya Stephens-Boal. Care Quality Commission: Ms Beverley Gray.

  • Contributors The author contributions were as follows: Conception (AHD, JS and MM); design of the work (AHD, JS, MM, SP, SW, BJH, TE, MG, JN, DE, DJW, CB, ZH, SS, LB, AS-B and BG); drafting the first version of the manuscript (SP); critical review and revision of manuscript (AHD, JS, MM, SW, BJH, TE, MG, JN, DE, DJW, CB, ZH, SS, LB, AS-B and BG).

  • Funding This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (NIHR133776). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

  • Disclaimer Imperial College London is the main sponsor for this study. Delegated responsibilities are assigned to the NHS Trusts/Health Boards taking part in this study.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.