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)
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)
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.
Adult, Aftercare, Anticoagulants, Hospitals, Humans, Patient Discharge, Quality of Life, Stockings, Compression/adverse effects, Venous Thromboembolism/prevention & control, vascular medicine, thromboembolism, surgery
e069802
Machin, Matthew
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Peerbux, Sarrah
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Whittley, Sarah
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Hunt, Beverley J
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Everington, Tamara
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Gohel, Manjit
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Norrie, John
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Epstein, David
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Warwick, David J
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Baker, Christopher
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Hamady, Zaed
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Smith, Sasha
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Bolton, Layla
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Stephens-Boal, Annya
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Gray, Beverley
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Shalhoub, Joseph
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Davies, Alun Huw
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17 January 2023
Machin, Matthew
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Peerbux, Sarrah
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Whittley, Sarah
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Hunt, Beverley J
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Everington, Tamara
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Gohel, Manjit
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Norrie, John
d648d104-39a0-481f-af0f-9a7209d50fb5
Epstein, David
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Warwick, David J
c034cee0-7adc-440d-80dd-2159c950df74
Baker, Christopher
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Hamady, Zaed
545a1c81-276e-4341-a420-aa10aa5d8ca8
Smith, Sasha
d3183421-06b0-4001-823c-5605df8b268e
Bolton, Layla
146f0144-490f-4781-bef4-ddb4656e9472
Stephens-Boal, Annya
acbff929-c0be-4285-acfb-a7a30571bf20
Gray, Beverley
ba0bf6d2-7ee5-4484-87d8-3313f69fd724
Shalhoub, Joseph
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Davies, Alun Huw
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Machin, Matthew, Peerbux, Sarrah, Whittley, Sarah, Hunt, Beverley J, Everington, Tamara, Gohel, Manjit, Norrie, John, Epstein, David, Warwick, David J, Baker, Christopher, Hamady, Zaed, Smith, Sasha, Bolton, Layla, Stephens-Boal, Annya, Gray, Beverley, Shalhoub, Joseph and Davies, Alun Huw
(2023)
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).
BMJ Open, 13 (1), , [069802].
(doi:10.1136/bmjopen-2022-069802).
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.
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Accepted/In Press date: 4 January 2023
e-pub ahead of print date: 17 January 2023
Published date: 17 January 2023
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Publisher Copyright:
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.
Keywords:
Adult, Aftercare, Anticoagulants, Hospitals, Humans, Patient Discharge, Quality of Life, Stockings, Compression/adverse effects, Venous Thromboembolism/prevention & control, vascular medicine, thromboembolism, surgery
Identifiers
Local EPrints ID: 485378
URI: http://eprints.soton.ac.uk/id/eprint/485378
ISSN: 2044-6055
PURE UUID: 4eecd367-6e5a-4ac6-8bdf-5d6afb362333
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Date deposited: 05 Dec 2023 17:40
Last modified: 21 Mar 2024 03:08
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Contributors
Author:
Matthew Machin
Author:
Sarrah Peerbux
Author:
Sarah Whittley
Author:
Beverley J Hunt
Author:
Tamara Everington
Author:
Manjit Gohel
Author:
John Norrie
Author:
David Epstein
Author:
David J Warwick
Author:
Christopher Baker
Author:
Zaed Hamady
Author:
Sasha Smith
Author:
Layla Bolton
Author:
Annya Stephens-Boal
Author:
Beverley Gray
Author:
Joseph Shalhoub
Author:
Alun Huw Davies
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