title: Graduated Compression Stockings as an Adjunct to Low Dose Low Molecular Weight Heparin in Venous Thromboembolism Prevention in Surgery: A Multicentre Randomised Controlled Trial.
abstract: The evidence base upon which current global venous thromboembolism (VTE) prevention recommendations have been made is not optimal. The cost of purchasing and applying graduated compression stockings (GCS) in surgical patients is considerable and has been estimated at £63.1 million per year in England alone.
  
  
  
  The aim was to determine whether low dose low molecular weight heparin (LMWH) alone is non-inferior to a combination of GCS and low dose LMWH for the prevention of VTE.
  
  
  
  The randomised controlled Graduated compression as an Adjunct to Pharmacoprophylaxis in Surgery (GAPS) Trial (ISRCTN 13911492) will randomise adult elective surgical patients identified as being at moderate and high risk of VTE to receive either the current "standard" combined thromboprophylactic LMWH with GCS mechanical thromboprophylaxis, or thromboprophylactic LMWH pharmacoprophylaxis alone. To show non-inferiority (3.5% non-inferiority margin) for the primary endpoint of all VTE within 90 days, 2236 patients are required. Recruitment will be from seven UK centres. Secondary outcomes include quality of life, compliance with stockings and LMWH, overall mortality, and GCS or LMWH related complications (including bleeding). Recruitment commenced in April 2016 with the seven UK centres coming "on-line" in a staggered fashion. Recruitment will be over a total of 18 months. The GAPS trial is funded by the National Institute for Health Research Health Technology Assessment in the UK (14/140/61).
authors.affiliation: Academic Section of Vascular Surgery, Department of Surgery & Cancer, Imperial College London, UK.
authors.forename: J
authors.initials: J
authors.lastname: Shalhoub
authors.affiliation: Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, UK.
authors.forename: J
authors.initials: J
authors.lastname: Norrie
authors.affiliation: Imperial College Healthcare NHS Trust, London, UK.
authors.forename: C
authors.initials: C
authors.lastname: Baker
authors.affiliation: University Department of Vascular Surgery, University of Birmingham, UK.
authors.forename: A W
authors.initials: AW
authors.lastname: Bradbury
authors.affiliation: Imperial College Healthcare NHS Trust, London, UK.
authors.forename: K
authors.initials: K
authors.lastname: Dhillon
authors.affiliation: Hampshire Hospitals NHS Foundation Trust, UK.
authors.forename: T
authors.initials: T
authors.lastname: Everington
authors.affiliation: Department of Vascular Surgery, Cambridge University Hospitals NHS Foundation Trust, UK.
authors.forename: M S
authors.initials: MS
authors.lastname: Gohel
authors.affiliation: University Hospital Southampton NHS Foundation Trust, UK.
authors.forename: Z
authors.initials: Z
authors.lastname: Hamady
authors.affiliation: Academic Section of Vascular Surgery, Department of Surgery & Cancer, Imperial College London, UK.
authors.forename: F
authors.initials: F
authors.lastname: Heatley
authors.affiliation: Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, UK.
authors.forename: J
authors.initials: J
authors.lastname: Hudson
authors.affiliation: Guy's & St Thomas' NHS Foundation Trust, London, UK.
authors.forename: B J
authors.initials: BJ
authors.lastname: Hunt
authors.affiliation: Academic Section of Vascular Surgery, Department of Surgery & Cancer, Imperial College London, UK.
authors.forename: R
authors.initials: R
authors.lastname: Lawton
authors.affiliation: Northern Vascular Unit, University of Newcastle upon Tyne, UK.
authors.forename: G
authors.initials: G
authors.lastname: Stansby
authors.affiliation: Thrombosis UK, UK.
authors.forename: A
authors.initials: A
authors.lastname: Stephens-Boal
authors.affiliation: Portsmouth Hospitals NHS Trust, UK.
authors.forename: S
authors.initials: S
authors.lastname: Toh
authors.affiliation: University Hospital Southampton NHS Foundation Trust, UK.
authors.forename: D
authors.initials: D
authors.lastname: Warwick
authors.affiliation: Academic Section of Vascular Surgery, Department of Surgery & Cancer, Imperial College London, UK. Electronic address: a.h.davies@imperial.ac.uk.
authors.forename: A H
authors.initials: AH
authors.lastname: Davies
mesh_terms: D002985:Clinical Protocols; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D012107:Research Design; D012307:Risk Factors; D053828:Stockings, Compression; D013514:Surgical Procedures, Operative / Q000009:adverse effects*; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D054556:Venous Thromboembolism / Q000000981:diagnostic imaging / Q000209:etiology / Q000517:prevention & control*
chemical_list: D005343:Fibrinolytic Agents; D006495:Heparin, Low-Molecular-Weight
keywords: Deep vein thrombosis; Graduated compression stockings; Low molecular weight heparin; Randomised controlled trial; Thromboprophylaxis; Venous thromboembolism