Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients

Venous Thromboembolism Clinical Trial

— PETS  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05347550
• Other study ID #: 22CX7651
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Imperial College London
• Contact: Sarah Whittley
• Phone: 0203 311 7371
• Email: s.whittley[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21472
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Other:
• Graduated Compression Stockings - Thromboembolic deterrent stockings
Centres randomised to the intervention arm will consist of participants receiving GCS.

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (3)

Lead Sponsor	Collaborator
Imperial College London	Universidad de Granada, University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality		90-days
Secondary	Quality of Life	Quality of Life assessed using the EQ-5D	7 and 90-days
Secondary	Adverse events related to GCS	Adverse events related to GCS for those in the intervention arm only	7-days
Secondary	Health Economic Outcome	Incremental Cost-Effectiveness Ratio (ICER)	2 years