Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients
PETS
1 other identifier
interventional
21,472
1 country
9
Brief Summary
Hospital acquired thrombosis describes blood clots that form in the legs and lungs after someone is treated in hospital. Clots in the leg can cause swelling, pain and other problems. If a clot in the leg travels to the lungs, it may be life threatening. Having surgery increases the risk of developing blood clots. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2022
CompletedFirst Posted
Study publicly available on registry
April 26, 2022
CompletedStudy Start
First participant enrolled
September 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMarch 28, 2024
March 1, 2024
2.8 years
April 8, 2022
March 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The rate of symptomatic VTE within 90 days
The rate of symptomatic VTE for surgical patients undergoing short-stay procedures assessed as being at low-risk of VTE
90-days
Secondary Outcomes (4)
Mortality
90-days
Quality of Life
7 and 90-days
Adverse events related to GCS
7-days
Health Economic Outcome
2 years
Study Arms (2)
Control - No graduated compression stockings
NO INTERVENTIONIn those centres randomised to the control arm, participants will not receive Graduated Compression Stockings (GCS).
Intervention - The provision of graduated compression stockings
EXPERIMENTALCentres 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).
Interventions
Centres randomised to the intervention arm will consist of participants receiving GCS.
Eligibility Criteria
You may qualify if:
- Adults (18-59 years of age) scheduled to undergo a surgical procedure with a hospital stay \<48 hours
- Individuals assessed as being at low-risk of developing VTE as per the DHRA Tool (i.e. no assessed thrombosis risk factors / scoring 0)
You may not qualify if:
- Individuals with a contraindication to GCS
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- University of Edinburghcollaborator
- Universidad de Granadacollaborator
Study Sites (9)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alun Davies
Imperial College London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2022
First Posted
April 26, 2022
Study Start
September 8, 2022
Primary Completion
June 30, 2025
Study Completion
December 31, 2025
Last Updated
March 28, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share