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).


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
17 01 2023
Historique:
entrez: 18 1 2023
pubmed: 19 1 2023
medline: 21 1 2023
Statut: epublish

Résumé

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. 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. 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. ISRCTN13908683.

Identifiants

pubmed: 36653057
pii: bmjopen-2022-069802
doi: 10.1136/bmjopen-2022-069802
pmc: PMC9853211
doi:

Substances chimiques

Anticoagulants 0

Types de publication

Randomized Controlled Trial Multicenter Study Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e069802

Informations de copyright

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

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Auteurs

Matthew Machin (M)

Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK.
Imperial Vascular Unit, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK.

Sarrah Peerbux (S)

Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK.

Sarah Whittley (S)

Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK.

Beverley J Hunt (BJ)

Thrombosis & Haemophilia Centre, Guy's and St Thomas' NHS Foundation Trust, London, UK.

Tamara Everington (T)

Hampshire Hospitals NHS Foundation Trust, Winchester, Hampshire, UK.

Manjit Gohel (M)

Department of Vascular Surgery, Addenbrooke's Hospital, Cambridge, UK.

John Norrie (J)

Usher Institute of Population Health Sciences and Informatics, Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.

David Epstein (D)

Faculty of Economic and Business Sciences, University of Granada, Granada, Spain.

David J Warwick (DJ)

University Hospital Southampton NHS Foundation Trust, Southampton, UK.

Christopher Baker (C)

Imperial Vascular Unit, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK.

Zaed Hamady (Z)

General Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK.

Sasha Smith (S)

Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK.

Layla Bolton (L)

Imperial Vascular Unit, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK.

Annya Stephens-Boal (A)

Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK.

Beverley Gray (B)

Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK.

Joseph Shalhoub (J)

Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK.
Imperial Vascular Unit, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK.

Alun Huw Davies (AH)

Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK a.h.davies@imperial.ac.uk.
Imperial Vascular Unit, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK.

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Classifications MeSH