RecruitingInterventional

A randomised controlled trial investigating the effects of compression stockings in patients who require blood thinning medication post discharge from elective surgery

After certain planned operations, patients face a higher risk of developing blood clots in their legs or lungs. To prevent this, doctors routinely prescribe blood-thinning medicine to take at home. Many patients are also asked to wear tight compression stockings. While blood thinners are known to work very well, it is unclear whether wearing compression stockings provides any extra benefit. Stockings can sometimes rub the skin or feel uncomfortable, and providing them costs the NHS millions of pounds each year. This trial compares two groups: patients who take blood thinners and wear stockings, and patients who take blood thinners alone. You will be followed for three months with simple surveys and one leg scan. The results will help doctors understand the best, safest, and most comfortable way to care for people after surgery.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

4,696

Start

01 May 2024

Estimated completion

31 Aug 2027

Venous thromboembolism

What is this study about?

When you have a major planned operation, your body needs time to heal and you may move around less than usual. This temporary lack of movement increases the chance of a blood clot forming in the veins of your legs (known as a deep vein thrombosis) or travelling to your lungs. In the UK, thousands of people experience hospital-associated blood clots each year, which is why prevention is a top priority for doctors.

Currently, high-risk patients are prescribed a course of blood-thinning medication to take after they leave hospital. In addition, many hospitals also give patients tight, elastic compression stockings to wear. While blood-thinning medications have been thoroughly tested and proven to work, there is very little proof that adding compression stockings offers any extra protection. Compression stockings can also be difficult to put on, uncomfortable to wear, and can occasionally cause skin sores.

This trial aims to answer two important questions: does adding compression stockings actually lower the risk of blood clots compared to blood-thinning medication alone, and do stockings cause unwanted side effects? By joining, you help researchers gather the evidence needed to update NHS guidelines, potentially sparing future patients from wearing uncomfortable stockings if they are not necessary.

Key takeaways

The study tests whether compression stockings give extra benefit when taking blood thinners after surgery.
Half of the participants will wear stockings and take blood thinners; the other half will take blood thinners alone.
Participation lasts for three months and includes three short check-ins by phone or online.
You will receive a free leg ultrasound scan around one month after surgery to check your veins.
Joining is completely voluntary and will not change your planned surgical care or medication.

Who may be eligible?

You may be able to join this study if you are 18 or older and are scheduled for a planned operation that requires you to take blood-thinning medication at home after you are discharged. This commonly includes procedures such as hip or knee replacements, as well as major bowel, stomach, gynaecological, or urinary surgeries.

You will not be able to participate if your doctor has advised that you cannot safely take blood thinners or wear compression stockings. You will also be excluded if you already take long-term blood thinners for a previous clot or heart condition, or if you have a known blood-clotting disorder.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I am having planned (elective) surgery, such as joint replacement or major abdominal surgery.
My doctor has prescribed blood-thinning medicine for me to take at home after discharge.
I do not already take long-term blood-thinning medication for past clots.
I have not been diagnosed with a genetic blood clotting disorder.
I have no medical reasons preventing me from wearing stockings or taking blood thinners.

Answer every question to see your result.

What does participation involve?

Taking part in the trial lasts for three months following your operation. Before leaving the hospital, you will be randomly placed into one of two groups by a computer (like flipping a coin). One group will take their prescribed blood thinners and wear compression stockings. The other group will take their blood thinners without wearing stockings.

During your recovery, the research team will check in on you three times: at 7 days, between 21 and 35 days, and at 90 days after surgery. These check-ins are quick and can be completed over the phone or through an online survey sent by text or email. You will also be invited to the hospital between day 21 and 35 for a quick, painless ultrasound scan of your legs to check for any hidden blood clots.

Potential risks and benefits

A potential benefit of joining is having an extra ultrasound scan of your legs, which can detect small blood clots that might otherwise go unnoticed. You will also receive clear information on how to spot the signs of a blood clot. The risks of taking part are low. If you are in the stocking group, you may find them tight or uncomfortable, and there is a small chance of mild skin irritation or rubbing. Taking part is completely voluntary, and you can change your mind and leave the study at any point without it affecting your standard NHS treatment.

Locations (35)

Charing Cross Hospital
Approximate
London, England
St Mary's Hospital
Approximate
London, England
University College London Hospitals NHS Foundation Trust
City only
London, England
North Bristol NHS Trust
City only
Bristol, England
Barnsley Hospital NHS Foundation Trust
City only
Barnsley, England
Oxford University Hospitals NHS Foundation Trust
Unverified
Oxford, England
Sherwood Forest Hospitals NHS Foundation Trust
Unverified
Sutton-in-ashfield, England
Northern Care Alliance NHS Foundation Trust
Unverified
Salford, England
Sheffield Teaching Hospitals NHS Foundation Trust
Unverified
Sheffield, England
The Rotherham NHS Foundation Trust
Unverified
Rotherham, England
University Hospital Southampton NHS Foundation Trust
Unverified
Southampton, England
Gloucestershire Hospitals NHS Foundation Trust
Unverified
Cheltenham, England

Common questions

Why do doctors prescribe compression stockings?

Compression stockings gently squeeze your legs to keep blood flowing smoothly toward your heart, which doctors have historically used to help stop clots from forming.

Can I choose whether I wear the stockings?

No. A computer randomly decides whether you will wear stockings alongside your medication or take the medication alone, ensuring the test results are completely fair.

What happens during the leg ultrasound scan?

An ultrasound is completely painless and safe. A healthcare professional places a small handheld probe with some cool gel onto your leg to look at blood flow in your veins.

What if the stockings cause pain or skin sores?

If you are assigned to wear stockings and they rub your skin, cause pain, or feel too tight, you should let your research team or doctor know straight away so they can check your legs.

Will taking part change my surgery or medication?

No. Your operation and your prescribed blood-thinning tablets or injections will stay exactly as your surgical team planned. The only difference is whether you wear stockings at home.

How to find out more

Francine Heatley

f.heatley@imperial.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.