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

March 27, 2024 updated by: Imperial College London

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

21472

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Barnsley, United Kingdom
        • Recruiting
        • Barnsley Hospital NHS Foundation Trust
      • Camberley, United Kingdom
        • Recruiting
        • Frimley Health NHS Foundation Trust
      • East Grinstead, United Kingdom
        • Recruiting
        • Queen Victoria Hospital NHS Foundation Trust
      • London, United Kingdom
        • Recruiting
        • Imperial College Hospital NHS Foundation Trust
      • Middlesbrough, United Kingdom
        • Recruiting
        • South Tees Hospitals NHS Foundation Trust
      • Newcastle Upon Tyne, United Kingdom
        • Recruiting
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust
      • Nottingham, United Kingdom
        • Recruiting
        • Sherwood Forest Hospital NHS Foundation Trust
      • Stockton-on-Tees, United Kingdom
        • Recruiting
        • North Tees and Hartlepool NHS Foundation Trust
      • Taunton, United Kingdom
        • Recruiting
        • Somerset NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control - No graduated compression stockings
In those centres randomised to the control arm, participants will not receive Graduated Compression Stockings (GCS).
Experimental: Intervention - The provision of graduated compression stockings
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).
Other: Graduated Compression Stockings - Thromboembolic deterrent stockings
Centres randomised to the intervention arm will consist of participants receiving GCS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90-days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

University of Edinburgh
Universidad de Granada

Investigators

  • Principal Investigator: Alun Davies, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2022

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 8, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22CX7651

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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