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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Venous Thromboembolism

Intervention / Treatment
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* Other: Graduated Compression Stockings - Thromboembolic deterrent stockings


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cluster, Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism