Evaluating the role of graduated compression stockings in the prevention of blood clots in patients who undergo short-stay surgery and who are assessed as being low-risk of developing blood clots
| ISRCTN | ISRCTN13908683 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13908683 |
| IRAS number | 312752 |
| Secondary identifying numbers | IRAS 312752, NIHR133776 |
- Submission date
- 25/03/2022
- Registration date
- 29/03/2022
- Last edited
- 11/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Hospital acquired thrombosis is a term used to describe blood clots that may form in the legs and lungs after someone is treated in hospital. A clot in the leg can cause swelling, pain and other long-term problems, such as a leg wound (ulcer). If a clot in the leg breaks off and travels to the lungs, it can cause problems with the lungs' ability to transfer oxygen from the air into the blood and may be life threatening. Having surgery increases a person's risk of developing blood clots. There are a number of reasons for this including being unwell, being unable to move during surgery, and moving around less after surgery. To reduce the chance of a blood clot developing, doctors can give blood-thinning medications and elastic stockings that squeeze the leg muscles.
People having short stay surgery are those who are able to go home the same day or those who stay overnight but go home shortly afterwards. These people are at 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 to reduce the chance of developing a blood clot. The risks of wearing the stockings are very low but wearing stockings can be uncomfortable. Occasionally some people with poor blood supply to their feet, can develop wounds on one or both of their feet after wearing elastic stockings, but this is rare.
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. Collectively, these elastic stockings cost the NHS a lot of money and it remains unknown if they benefit these people.
A recent study in a different group of people, who are at higher risk of developing a blood clot and are usually given blood-thinning medications, showed that elastic stockings offered no additional benefit compared to just having blood-thinning medications alone. There are currently no up to date studies specifically in this group of people that look at whether these elastic stockings reduce the chance of developing a blood clot.
The purpose of this study is to investigate if it is worthwhile to continue using elastic stockings in people having surgery where the risk of developing blood clots is low.
Who can participate?
People enrolled in the study will be over the age of 18 and scheduled to undergo a surgical procedure with a hospital stay less than 48 hours. All participants will be checked for their risk of blood clots when they arrive in hospital for surgery. This study will only include people where the check shows a low risk of developing blood clots, which will be assessed using a nationally recognised tool.
What does the study involve?
At random, participants will be given elastic stockings to wear during their time in hospital or not given elastic stockings at all. The surgery itself and all other processes will continue as normal.
Participants will be contacted (by telephone, email or SMS) at 7 days and 90 days after their surgery to see how they are getting on and to see if they developed a blood clot. Participants will be provided with information on the signs and symptoms of blood clots, such as a swollen painful leg. They will be advised to attend the emergency department if they develop any of the signs and symptoms, and not wait for the follow-up to avoid delay. If the doctors and nurses suspect a participant has developed a blood clot, they will come to hospital for extra tests and treatment which is best practice if a blood clot is suspected.
What are the possible benefits and risks of participating?
Possible benefits: Participants will receive increased education around VTE prevention (i.e. via the ‘Signs and Symptoms of a blood clot’ leaflet). Both patients and the health service stand to benefit from evidence to support the safe rationalisation of the use of GCS as a health technology.
Possible risks: The risks associated with graduated compression (GCS) use are low, particularly in this patient cohort where the expectation is to wear the stockings for a short period of time (i.e. from the time of surgery until ambulant [which may be as short as a few hours and no longer than 48-hours]). GCS may cause skin irritation and itching. Patients will be advised to speak to their healthcare professional at any point prior to (and indeed after) discharge should they have any concerns. Individuals with a contraindication to wearing GCS will not be included. The relevant participants will also be followed up at 7-days post procedure and information about any adverse events associated with GCS will be captured. We do not expect participation to result in any additional burden on the participant. Participants will be followed-up remotely at 7 and 90-days post-surgical procedure. Data can be provided via online survey, SMS or telephone depending on patient preference. Minimal data collection will occur at these follow-ups (i.e. only self-reported VTE outcome data, the short 5-item EQ-5D questionnaire and information on adverse events associated with GCS [if applicable] is collected at 7-days. At 90-days, only self-reported VTE outcome, the EQ-5D and the resource use questionnaire data is collected).
Where is the study run from?
Imperial College London (UK)
When is the study starting and how long is it expected to run for?
March 2022 to December 2025
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
1. Sarrah Peerbux (public contact), s.peerbux@imperial.ac.uk
2. Prof. Alun Davies (scientific contact), a.h.davies@imperial.ac.uk
Contact information
Principal Investigator
Imperial College London, Academic Section of Vascular Surgery
Room 3, 4th Floor East Wing, Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
| Phone | +44 (0)20 3311 7309 |
|---|---|
| a.h.davies@imperial.ac.uk |
Public
Imperial College London, Academic Section of Vascular Surgery
Room 3E, 4th Floor East Wing, Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
 ORCID ID |
0000-0001-5560-0749 |
|---|---|
| Phone | +44 (0)7866 767516 |
| s.peerbux@imperial.ac.uk |
Study information
| Study design | Multicentre cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| Scientific title | Examining the benefit of graduated compression stockings in the Prevention of vEnous Thromboembolism in low-risk Surgical patients: a multicentre cluster randomised controlled trial (PETS Trial) |
| Study acronym | PETS |
| Study hypothesis | The principal objective of this study is to evaluate the potential benefit of GCS in the prevention of VTE in patients undergoing short-stay surgical procedures, assessed as being at low-risk for VTE. |
| Ethics approval(s) | Approved 31/05/2022, London - Camden and King’s Cross REC (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 207 1048089; camdenandkingscross.rec@hra.nhs.uk), ref: 22/LO/0390 |
| Condition | Prevention of venous thromboembolism (VTE) in patients who are deemed to be at low-risk of developing VTE and who undergo day-case/short-stay surgical procedures. |
| Intervention | This is a cluster-designed RCT in which study centres will either be randomised to intervention or control. 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. preassessment or 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). In those centres randomised to the control arm, participants will not receive graduated compression stockings. |
| Intervention type | Behavioural |
| Primary outcome measure | Self-reported VTE within 90-days of short-stay surgical procedure. |
| Secondary outcome measures | 1. Mortality measured using patient notes and SAE log review at 7 and 90-days 2. Cost-Effectiveness Ratio measured using the Incremental Cost-Effectiveness Ratio (ICER) at 90 days 3. Generic Quality of life (as measured by the EQ-5D) at 7 and 90-days 4. Adverse events with GCS (at 7-days, for participants enrolled in the site randomised to the ‘stockings’ cluster only) measured using patient records |
| Overall study start date | 25/03/2022 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 59 Years |
| Sex | Both |
| Target number of participants | 21472 |
| Total final enrolment | 11321 |
| Participant inclusion criteria | 1. Adults (18-59 years of age) scheduled to undergo a surgical procedure with a hospital stay <48 hours 2. Individuals assessed as being at low-risk of developing VTE as per the DHRA tool i.e. no assessed thrombosis risk factors / scoring 0 |
| Participant exclusion criteria | Current exclusion criteria as of 12/09/2024: 1. Individuals with a contraindication to GCS 2. Individuals assessed as being at moderate or high risk of VTE as per the DHRA tool 3. Individuals requiring therapeutic anticoagulation 4. Individuals requiring pharmacological prophylaxis 5. Individuals with thrombophilia/ thrombogenic disorder 6. Individuals with a previous history of VTE 7. Individuals requiring intermittent pneumatic compression therapy beyond theatre and recovery 8. Female patients of childbearing age who have a positive pregnancy test 9. Individuals with lower limb immobilisation 10. Inability to provide informed consent _____ Previous exclusion criteria as of 14/08/2023 to 12/09/2024: 1. Individuals with a contraindication to GCS 2. Individuals assessed as being at moderate or high risk of VTE as per the DHRA tool 3. Individuals requiring therapeutic anticoagulation 4. Individuals with thrombophilia/ thrombogenic disorder 5. Individuals with a previous history of VTE 6. Individuals requiring intermittent pneumatic compression therapy beyond theatre and recovery 7. Individuals requiring extended thromboprophylaxis beyond discharge 8. Female patients of childbearing age who have a positive pregnancy test 9. Individuals with lower limb immobilisation 10. Inability to provide informed consent 11. Individuals requiring pharmacological prophylaxis _____ Previous exclusion criteria: 1. Individuals with a contraindication to GCS 2. Individuals assessed as being at moderate or high-risk of VTE as per the DHRA tool 3. Individuals requiring therapeutic anticoagulation 4. Individuals with thrombophilia/ thrombogenic disorder 5. Individuals with a previous history of VTE 6. Individuals requiring intermittent pneumatic compression therapy beyond theatre and recovery 7. Individuals requiring extended thromboprophylaxis beyond discharge 8. Female patients of childbearing age who have a positive pregnancy test 9. Individuals with lower limb immobilisation 10. Inability to provide informed consent. |
| Recruitment start date | 08/09/2022 |
| Recruitment end date | 18/11/2024 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Westcliff-on-sea
SS0 0RY
United Kingdom
United Kingdom
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
London
NW1 2PG
United Kingdom
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom
St Marys Hospital
South Wharf Road
London
W2 1BL
United Kingdom
Harrow
HA1 3UJ
United Kingdom
Frimley
Camberley
GU16 7UJ
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
St Davids Parc
Job's Well Road
Carmarthen
SA31 3BB
United Kingdom
Wigginton Road
York
YO31 8HE
United Kingdom
Holdforth Road
Hartlepool
TS24 9AH
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
United Kingdom
80 Newark Street
London
E1 2ES
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
369 Fulham Road
London
SW10 9NH
United Kingdom
United Kingdom
Uxbridge
UB8 3NN
United Kingdom
Poole Hospital
Longfleet Road
Poole
BH15 2JB
United Kingdom
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Seaway Parade Industrial Estate
Baglan
Port Talbot
SA12 7BR
United Kingdom
Gartnavel Royal Hospital
1055 Great Western Road Glasgow
Glasgow
G12 0XH
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Pensnett Road
Dudley
DY1 2HQ
United Kingdom
Barnsley
S75 2EP
United Kingdom
Skipton Road
Steeton
Keighley
BD20 6TD
United Kingdom
Mansfield Road
Sutton-in-ashfield
NG17 4JL
United Kingdom
East Grinstead
RH19 3DZ
United Kingdom
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom
Treliske
Truro
TR1 3LJ
United Kingdom
London
E9 6SR
United Kingdom
Dryburn Hospital
North Road
Durham
DH1 5TW
United Kingdom
Hollyhurst Road
Darlington
DL3 6HX
United Kingdom
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom
Rake Lane
North Shields
NE29 8NH
United Kingdom
Derriford Road
Derriford
Plymouth
PL6 8DH
United Kingdom
27 Union Walk
Hereford
HR1 2ER
United Kingdom
Scartho Road
Grimsby
DN33 2BA
United Kingdom
Lakin Road
Warwick
CV34 5BW
United Kingdom
Harlow
CM20 1QX
United Kingdom
Victoria Road
Macclesfield
SK10 3BL
United Kingdom
Calow
Chesterfield
S44 5BL
United Kingdom
Liverpool Road
Chester
CH2 1UL
United Kingdom
Kettering
NN16 8UZ
United Kingdom
Dudley Road
Birmingham
B18 7QH
United Kingdom
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Marlborough Street
Bristol
BS1 3NU
United Kingdom
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
-
United Kingdom
10 Arthur Street
Ayr
KA7 1QJ
United Kingdom
Gorleston
Great Yarmouth
NR31 6LA
United Kingdom
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
Warrington Road
Prescot
L35 5DR
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Sponsor information
University/education
Room 215, Level 2, Medical School Building
Norfolk Place
London
W2 1PG
England
United Kingdom
| Phone | +44 207 594 1862 |
|---|---|
| becky.ward@imperial.ac.uk | |
| Website | http://www.imperial.ac.uk/ |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | This trial will provide evidence to guide widespread clinical practice and will facilitate an update of national and international guidelines. If the trial were to find that GCS offered no benefit, then providers would recommend against their use. This would prevent patients receiving unnecessary GCS and the lead to a subsequent re-allocation of resources which is estimated to be as much as £23.3 million per annum. We anticipate that this trial will inform NICE guidelines alongside publication in a high-impact journal, presentation at international conferences and dissemination on the Imperial College London, NIHR and Thrombosis UK websites and other media streams. |
| IPD sharing plan | Data sharing statement to be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.0 | 18/07/2022 | 13/10/2022 | No | No |
| Protocol article | 17/01/2023 | 19/01/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 3.0 | 29/11/2022 | 14/08/2023 | No | No |
| Protocol file | version 7.0 | 07/05/2024 | 12/09/2024 | No | No |
Additional files
Editorial Notes
11/03/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2025 to 18/11/2024.
2. The total final enrolment was added.
12/09/2024: The following changes were made:
1. The following study participating centres were added: Sherwood Forest Hospitals NHS Foundation Trust, Queen Victoria Hospital NHS Foundation Trust, Blackpool Teaching Hospitals NHS Foundation Trust (Blackpool Victoria Hospital), Royal Cornwall Hospitals NHS Foundation Trust, Homerton University Hospital NHS Foundation Trust, University Hospital of North Durham, County Durham and Darlington NHS Foundation Trust, Worcestershire Acute Hospitals NHS Trust, Northumbria Healthcare NHS Foundation Trust, University Hospitals Plymouth NHS Foundation Trust, Wye Valley NHS Trust, North Lincolnshire and Goole NHS Foundation Trust, South Warwickshire University NHS Foundation Trust, The Princess Alexandra Hospital NHS Trust, East Cheshire NHS Trust, Chesterfield Royal Hospital NHS Foundation Trust, Countess of Chester Hospital NHS Foundation Trust, Kettering General Hospital NHS Foundation Trust, Sandwell and West Birmingham NHS Trust, South Tyneside and Sunderland NHS Foundation Trust, University Hospitals Bristol And Weston NHS Foundation Trust, Wirral University Teaching Hospital NHS Foundation Trust, Milton Keynes University Hospital NHS Foundation Trust, Liverpool University Hospitals NHS Foundation Trust, Cleveland Clinic London, NHS Ayrshire and Arran, James Paget University Hospitals NHS Foundation Trust, University Hospitals Sussex NHS Foundation Trust, Mersey and West Lancashire Teaching Hospitals NHS Trust, and Manchester University NHS Foundation Trust.
2. The protocol (not peer reviewed) version 7.0 was added.
3. The participant exclusion criteria were updated.
14/08/2023: The following changes have been made:
1. Protocol file uploaded.
2. The participant exclusion criteria have been changed.
3. The public contact has been changed.
19/01/2023: Publication reference added.
14/10/2022: The following changes were made to the trial record:
1. A contact was changed.
2. The plain English summary was updated to reflect these changes.
13/10/2022: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The recruitment start date was changed from 01/10/2022 to 08/09/2022.
28/07/2022: The ethics approval was added.
29/03/2022: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
