Venous Thromboembolism
Conditions
Keywords
Cluster, Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism
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.
Interventions
OTHERGraduated Compression Stockings - Thromboembolic deterrent stockings
Centres randomised to the intervention arm will consist of participants receiving GCS.
Sponsors
University of Edinburgh
Universidad de Granada
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of symptomatic VTE within 90 days | 90-days | The rate of symptomatic VTE for surgical patients undergoing short-stay procedures assessed as being at low-risk of VTE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 90-days | — |
| Quality of Life | 7 and 90-days | Quality of Life assessed using the EQ-5D |
| Adverse events related to GCS | 7-days | Adverse events related to GCS for those in the intervention arm only |
| Health Economic Outcome | 2 years | Incremental Cost-Effectiveness Ratio (ICER) |
Countries
United Kingdom
Contacts
Primary ContactSarah Whittley
Outcome results
None listed