PETS Trial

Funder
National Institute for Health Research (NIHR) – Health Technology Assessment (HTA).

Aim 
To evaluate the potential benefit of Graduated Compression Stockings (GCS) in the prevention of Venous Thromboembolism (VTE) in patients undergoing short-stay surgical procedures, assessed as being at low-risk for VTE.

Design
A cluster randomised-controlled trial (RCT). Allocations will be at NHS Trust level where all patients who undergo short-stay surgery at site will be allocated GCS or no GCS.

Setting
This trial will take place in at least 50 NHS Trusts offering day case and short stay surgical services.

Target population
n=21,472

Examples of procedures from which patients at low-risk for venous thromboembolism (VTE) include (but are not limited to): inguinal hernia repair, laparoscopic cholecystectomy, operations to manage female incontinence, arthroscopic shoulder surgery and Dupuytren's fasciectomy.

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
• Individuals requiring pharmacological prophylaxis

Outcomes

Primary Outcome
The rate of symptomatic VTE within 90 days for surgical patients undergoing short-stay procedures assessed as being at low-risk of VTE for those treated with GCS in comparison to those not given GCS.

Secondary outcomes

• Mortality
• Incremental Cost-Effectiveness Ratio (ICER) up to 2 years
• Quality of life – EQ-5D administered at 7 and 90 days
• Adverse events with GCS

Follow up
Participants will be followed-up by telephone or online survey (sent via email or SMS) at 7-days and 90-days post-surgical procedure.