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Graduated Compression Stockings as an Adjunct to Low Dose Low Molecular Weight Heparin in Venous Thromboembolism Prevention in Surgery: A Multicentre Randomised Controlled Trial

Graduated Compression Stockings as an Adjunct to Low Dose Low Molecular Weight Heparin in Venous Thromboembolism Prevention in Surgery: A Multicentre Randomised Controlled Trial
Graduated Compression Stockings as an Adjunct to Low Dose Low Molecular Weight Heparin in Venous Thromboembolism Prevention in Surgery: A Multicentre Randomised Controlled Trial

BACKGROUND: 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.

OBJECTIVE: 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.

METHODS: 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).

Clinical Protocols, Combined Modality Therapy, Drug Administration Schedule, Fibrinolytic Agents/administration & dosage, Heparin, Low-Molecular-Weight/administration & dosage, Humans, Research Design, Risk Factors, Stockings, Compression, Surgical Procedures, Operative/adverse effects, Time Factors, Treatment Outcome, United Kingdom, Venous Thromboembolism/diagnostic imaging
1078-5884
880-885
Shalhoub, J
f851a314-7606-45a9-81d5-c9ca0c10d935
Norrie, J
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Baker, C
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Bradbury, A W
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Dhillon, K
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Everington, T
b43fbab1-4840-40b1-a278-3968ed19c86f
Gohel, M S
b9cae0e8-10e6-48ae-afb2-ce492e4bf184
Hamady, Z
545a1c81-276e-4341-a420-aa10aa5d8ca8
Heatley, F
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Hudson, J
5f5f7c9e-05f8-43dc-a43b-3c6573f226ed
Hunt, B J
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Lawton, R
1f8728a2-7097-4662-9717-4363ad058ef0
Stansby, G
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Stephens-Boal, A
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Toh, S
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Warwick, D
c034cee0-7adc-440d-80dd-2159c950df74
Davies, A H
8637b6c8-d13d-4b82-b83e-e05f2de9454d
GAPS trial investigators
Shalhoub, J
f851a314-7606-45a9-81d5-c9ca0c10d935
Norrie, J
d648d104-39a0-481f-af0f-9a7209d50fb5
Baker, C
66c098dd-5e13-4b03-a7e7-35122aef8f26
Bradbury, A W
bb8fbc3e-f5f4-4035-b76d-4178d45319f8
Dhillon, K
6dba9161-e22b-438f-97ca-4db18b9cc630
Everington, T
b43fbab1-4840-40b1-a278-3968ed19c86f
Gohel, M S
b9cae0e8-10e6-48ae-afb2-ce492e4bf184
Hamady, Z
545a1c81-276e-4341-a420-aa10aa5d8ca8
Heatley, F
05a28409-a64a-4f0c-bb62-656ae42d9bde
Hudson, J
5f5f7c9e-05f8-43dc-a43b-3c6573f226ed
Hunt, B J
378e177a-d1fa-4019-9432-96510cae76b1
Lawton, R
1f8728a2-7097-4662-9717-4363ad058ef0
Stansby, G
b63fc69d-ffc2-437a-b55a-08d935e1ddf5
Stephens-Boal, A
4a2ab47a-c11f-4a73-8bf0-69728d47d3c7
Toh, S
536ea564-fbaa-4f3c-873c-cde1556d90c4
Warwick, D
c034cee0-7adc-440d-80dd-2159c950df74
Davies, A H
8637b6c8-d13d-4b82-b83e-e05f2de9454d

GAPS trial investigators (2017) Graduated Compression Stockings as an Adjunct to Low Dose Low Molecular Weight Heparin in Venous Thromboembolism Prevention in Surgery: A Multicentre Randomised Controlled Trial. European Journal of Vascular and Endovascular Surgery, 53 (6), 880-885. (doi:10.1016/j.ejvs.2017.02.013).

Record type: Article

Abstract

BACKGROUND: 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.

OBJECTIVE: 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.

METHODS: 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).

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More information

Published date: June 2017
Keywords: Clinical Protocols, Combined Modality Therapy, Drug Administration Schedule, Fibrinolytic Agents/administration & dosage, Heparin, Low-Molecular-Weight/administration & dosage, Humans, Research Design, Risk Factors, Stockings, Compression, Surgical Procedures, Operative/adverse effects, Time Factors, Treatment Outcome, United Kingdom, Venous Thromboembolism/diagnostic imaging

Identifiers

Local EPrints ID: 455119
URI: http://eprints.soton.ac.uk/id/eprint/455119
ISSN: 1078-5884
PURE UUID: 95d9266a-7334-4c6b-b70c-1098973c21f0
ORCID for C Baker: ORCID iD orcid.org/0000-0002-0840-2333
ORCID for Z Hamady: ORCID iD orcid.org/0000-0002-4591-5226

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Date deposited: 10 Mar 2022 17:31
Last modified: 17 Mar 2024 04:12

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Contributors

Author: J Shalhoub
Author: J Norrie
Author: C Baker ORCID iD
Author: A W Bradbury
Author: K Dhillon
Author: T Everington
Author: M S Gohel
Author: Z Hamady ORCID iD
Author: F Heatley
Author: J Hudson
Author: B J Hunt
Author: R Lawton
Author: G Stansby
Author: A Stephens-Boal
Author: S Toh
Author: D Warwick
Author: A H Davies
Corporate Author: GAPS trial investigators

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