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

Primary Purpose

Venous Thromboembolism

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Graduated Compression Stockings - Thromboembolic deterrent stockings
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring Cluster, Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Barnsley Hospital NHS Foundation TrustRecruiting
  • Frimley Health NHS Foundation TrustRecruiting
  • Queen Victoria Hospital NHS Foundation TrustRecruiting
  • Imperial College Hospital NHS Foundation TrustRecruiting
  • South Tees Hospitals NHS Foundation TrustRecruiting
  • The Newcastle upon Tyne Hospitals NHS Foundation TrustRecruiting
  • Sherwood Forest Hospital NHS Foundation TrustRecruiting
  • North Tees and Hartlepool NHS Foundation TrustRecruiting
  • Somerset NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control - No graduated compression stockings

Intervention - The provision of graduated compression stockings

Arm Description

In those centres randomised to the control arm, participants will not receive Graduated Compression Stockings (GCS).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mortality
Quality of Life
Quality of Life assessed using the EQ-5D
Adverse events related to GCS
Adverse events related to GCS for those in the intervention arm only
Health Economic Outcome
Incremental Cost-Effectiveness Ratio (ICER)

Full Information

First Posted
April 8, 2022
Last Updated
November 15, 2022
Sponsor
Imperial College London
Collaborators
University of Edinburgh, Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT05347550
Brief Title
Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2022 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
University of Edinburgh, Universidad de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
Cluster, Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21472 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control - No graduated compression stockings
Arm Type
No Intervention
Arm Description
In those centres randomised to the control arm, participants will not receive Graduated Compression Stockings (GCS).
Arm Title
Intervention - The provision of graduated compression stockings
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Graduated Compression Stockings - Thromboembolic deterrent stockings
Intervention Description
Centres randomised to the intervention arm will consist of participants receiving GCS.
Primary Outcome Measure Information:
Title
The rate of symptomatic VTE within 90 days
Description
The rate of symptomatic VTE for surgical patients undergoing short-stay procedures assessed as being at low-risk of VTE
Time Frame
90-days
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
90-days
Title
Quality of Life
Description
Quality of Life assessed using the EQ-5D
Time Frame
7 and 90-days
Title
Adverse events related to GCS
Description
Adverse events related to GCS for those in the intervention arm only
Time Frame
7-days
Title
Health Economic Outcome
Description
Incremental Cost-Effectiveness Ratio (ICER)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Whittley
Phone
0203 311 7371
Email
s.whittley@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alun Davies
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnsley Hospital NHS Foundation Trust
City
Barnsley
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Frimley Health NHS Foundation Trust
City
Camberley
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Queen Victoria Hospital NHS Foundation Trust
City
East Grinstead
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Imperial College Hospital NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
South Tees Hospitals NHS Foundation Trust
City
Middlesbrough
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City
Newcastle Upon Tyne
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Sherwood Forest Hospital NHS Foundation Trust
City
Nottingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
North Tees and Hartlepool NHS Foundation Trust
City
Stockton-on-Tees
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Somerset NHS Foundation Trust
City
Taunton
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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