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
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Self-reported VTE within 90-days of short-stay surgical procedure. | — |
Secondary
| Measure | Time 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