Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients
NCT ID: NCT05347550
Last Updated: 2024-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
21472 participants
INTERVENTIONAL
2022-09-08
2025-12-31
Brief Summary
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People having short-stay surgery (who either go home the same day or who stay overnight but go home shortly afterwards) are at a much lower risk of developing a blood clot than those who stay in hospital for longer. These low-risk people are often given elastic stockings (which squeeze the leg muscles) to reduce the chance of a blood clot.
The risks of wearing the stockings are low but they can be uncomfortable. In the UK, there are over a million short stay surgeries performed each year and most of these people are given elastic stockings to wear. Stockings cost the NHS a lot of money and it remains unknown if they work.
This study will investigate if it is worthwhile to continue using elastic stockings in people having surgery where the risk of developing blood clots is low. Adults (over 18-years) who are at low risk of developing blood clots (assessed using a nationally recognised tool) will be included.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control - No graduated compression stockings
In those centres randomised to the control arm, participants will not receive Graduated Compression Stockings (GCS).
No interventions assigned to this group
Intervention - The provision of graduated compression stockings
Centres randomised to the intervention arm, which is the current standard of care, will consist of participants receiving Graduated Compression Stockings (GCS). Clinical staff (e.g. theatre support workers) will issue stockings to all patients who are scheduled to undergo short-stay surgery. Participants will be instructed to wear their stockings just before undergoing the surgical procedure and to remove the stockings as soon as they are ambulant (i.e. after the procedure).
Graduated Compression Stockings - Thromboembolic deterrent stockings
Centres randomised to the intervention arm will consist of participants receiving GCS.
Interventions
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Graduated Compression Stockings - Thromboembolic deterrent stockings
Centres randomised to the intervention arm will consist of participants receiving GCS.
Eligibility Criteria
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Inclusion Criteria
* Individuals assessed as being at low-risk of developing VTE as per the DHRA Tool (i.e. no assessed thrombosis risk factors / scoring 0)
Exclusion Criteria
* Individuals assessed as being at moderate or high-risk of VTE as per the DHRA tool
* Individuals requiring therapeutic anticoagulation
* Individuals with thrombophilia/ thrombogenic disorder
* Individuals with a previous history of VTE
* Individuals requiring intermittent pneumatic compression therapy beyond theatre and recovery
* Individuals requiring extended thromboprophylaxis beyond discharge
* Female patients of childbearing age who have a positive pregnancy test
* Individuals with lower limb immobilisation
* Inability to provide informed consent
18 Years
59 Years
ALL
Yes
Sponsors
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University of Edinburgh
OTHER
Universidad de Granada
OTHER
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Alun Davies
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Barnsley Hospital NHS Foundation Trust
Barnsley, , United Kingdom
Frimley Health NHS Foundation Trust
Camberley, , United Kingdom
Queen Victoria Hospital NHS Foundation Trust
East Grinstead, , United Kingdom
Imperial College Hospital NHS Foundation Trust
London, , United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough, , United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Sherwood Forest Hospital NHS Foundation Trust
Nottingham, , United Kingdom
North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees, , United Kingdom
Somerset NHS Foundation Trust
Taunton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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22CX7651
Identifier Type: -
Identifier Source: org_study_id
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