Clinical trial NCT05347550: Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Venous Thromboembolism
Keywords: Cluster
Venous Thromboembolism
Deep Vein Thrombosis
Pulmonary Embolism
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: University of Edinburgh
name: Universidad de Granada
First posted: 2022-04-26
Enrollment: 21472
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: The rate of symptomatic VTE within 90 days
timeFrame: 90-days
Secondary outcomes:
measure: Mortality
timeFrame: 90-days
measure: Quality of Life
timeFrame: 7 and 90-days
measure: Adverse events related to GCS
timeFrame: 7-days
measure: Health Economic Outcome
timeFrame: 2 years
Other outcomes:
Locations:
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital NHS Foundation Trust
city: Camberley
country: United Kingdom
facility: Frimley Health NHS Foundation Trust
city: East Grinstead
country: United Kingdom
facility: Queen Victoria Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Hospital NHS Foundation Trust
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Sherwood Forest Hospital NHS Foundation Trust
city: Stockton-on-Tees
country: United Kingdom
facility: North Tees and Hartlepool NHS Foundation Trust
city: Taunton
country: United Kingdom
facility: Somerset NHS Foundation Trust
Study officials:
affiliation: Imperial College London
name: Alun Davies
role: PRINCIPAL_INVESTIGATOR
References: