Venous ThromboembolismPETSNCT05347550
Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients
A study testing Graduated Compression Stockings - Thromboembolic deterrent stockings in people with Venous Thromboembolism, run by Imperial College London at 9 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Graduated Compression Stockings - Thromboembolic deterrent stockings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,472 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- 8 Sep 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites, 9 recruiting
- Recruiting
Barnsley Hospital NHS Foundation Trust
Barnsley
- Recruiting
Frimley Health NHS Foundation Trust
Camberley
- Recruiting
Queen Victoria Hospital NHS Foundation Trust
East Grinstead
- Recruiting
Imperial College Hospital NHS Foundation Trust
London
- Recruiting
South Tees Hospitals NHS Foundation Trust
Middlesbrough
- Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
- Recruiting
Sherwood Forest Hospital NHS Foundation Trust
Nottingham
- Recruiting
North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees
- Recruiting
Somerset NHS Foundation Trust
Taunton
About this study
Official 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)
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.
Read more
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.
- Conditions
- Venous Thromboembolism
- Being tested
- Graduated Compression Stockings - Thromboembolic deterrent stockings
- Keywords
- Cluster, Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graduated Compression Stockings - Thromboembolic deterrent stockingsOther
Centres randomised to the intervention arm will consist of participants receiving GCS.
| Study group | Role | What they receive |
|---|---|---|
| Control - No graduated compression stockings | No intervention | In those centres randomised to the control arm, participants will not receive Graduated Compression Stockings (GCS). |
| Intervention - The provision of graduated compression stockings | Experimental | 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). Receives: Other: Graduated Compression Stockings - Thromboembolic deterrent stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90-days
Secondary outcomes (4)
Mortality
Measured: 90-days
Quality of Life
Quality of Life assessed using the EQ-5D
Measured: 7 and 90-days
Adverse events related to GCS
Adverse events related to GCS for those in the intervention arm only
Measured: 7-days
Health Economic Outcome
Incremental Cost-Effectiveness Ratio (ICER)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start8 Sep 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21,472 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh, Universidad de Granada
- Responsible party
- Sponsor
- Investigators
- Alun Davies, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347550
- Sponsor's protocol ID
- 22CX7651
- Acronym
- PETS
- Status last verified
- Mar 2024
- First submitted
- 8 Apr 2022
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05347550
- Acronym / sponsor ID
- PETS / 22CX7651
- Conditions
- Venous Thromboembolism
- Keywords
- Cluster, Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21,472 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- University of Edinburgh, Universidad de Granada
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - No graduated compression stockings | No intervention | –In those centres randomised to the control arm, participants will not receive Graduated Compression Stockings (GCS). |
| Intervention - The provision of graduated compression stockings | Experimental | Other: Graduated Compression Stockings - Thromboembolic deterrent stockingsCentres 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). |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graduated Compression Stockings - Thromboembolic deterrent stockingsCentres randomised to the intervention arm will consist of participants receiving GCS. | Other | Intervention - The provision of graduated compression stockings |
Primary outcome
The rate of symptomatic VTE within 90 days
Time frame: 90-days
The rate of symptomatic VTE for surgical patients undergoing short-stay procedures assessed as being at low-risk of VTE
4 secondary outcomes
Mortality
Time frame: 90-days
Quality of Life
Time frame: 7 and 90-days
Adverse events related to GCS
Time frame: 7-days
Health Economic Outcome
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alun Davies principal investigator
Imperial College London
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graduated Compression Stockings - Thromboembolic deterrent stockings in people with Venous Thromboembolism, run by Imperial College London at 9 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Whittley (0203 311 7371, s.whittley@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of symptomatic VTE within 90 days (time frame: 90-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.