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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

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)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13908683
Enrollment
21472
Registered
2022-03-29
Start date
2022-09-08
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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. Circulatory System

Interventions

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 co

Sponsors

Imperial College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Self-reported VTE within 90-days of short-stay surgical procedure.

Secondary

MeasureTime frame
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

Countries

England, Scotland, United Kingdom, Wales

Contacts

Public ContactSarrah Peerbux
s.peerbux@imperial.ac.uk+44 (0)7866 767516

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 10, 2026