RecruitingNAINTERVENTIONAL

GRACE: Evaluating Compression Stockings in Patients That Require Extended Duration Pharmacological Thromboprophylaxis

If you're having major surgery, there's a risk of blood clots forming in your legs (DVT) or travelling to your lungs (PE). Hospitals usually give blood-thinning medicine and offer special elastic stockings to help prevent these. This study, called GRACE, is investigating if these stockings are still necessary when patients are already receiving blood-thinning medicine during and after their hospital stay. Researchers want to know if stockings truly offer extra protection against clots, or if patients could avoid the discomfort and potential issues of wearing them without increasing their clot risk. The study will help the NHS decide if these stockings are good value for money and genuinely improve patient safety after surgery.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

8,608

Start

27 Apr 2024

Estimated completion

31 Mar 2027

Venous Thromboembolism Surgery

What is this study about?

When you have an operation, especially a big one like cancer surgery or hip replacements, there's a chance that blood clots could form in your legs. These clots can be painful and cause swelling, or they could become serious if they travel to your lungs. To prevent this, hospitals usually give you medicine to thin your blood. They also often provide special elastic stockings, called compression stockings, to wear on your legs. These stockings are designed to help blood flow better and stop it from pooling, which can reduce the risk of clots.

However, some doctors are now questioning whether these stockings are always needed, particularly for patients who are already taking blood-thinning medicine for an extended period. We know that these blood-thinning medicines are very effective, but it's not clear if the stockings add much extra protection. The stockings can sometimes be uncomfortable, might irritate the skin, and they also cost the NHS a lot of money each year. If they don't provide a significant extra benefit, then patients might not need to wear them, which would make recovery more comfortable and save resources.

This study, called GRACE, aims to find a clear answer. It will compare patients who have blood-thinning medicine and wear stockings, with patients who only have the blood-thinning medicine. Everyone in the study will be at a high risk of developing clots, meaning they're the people who usually get both types of prevention. By comparing these two groups, researchers hope to understand if the stockings truly make a difference in preventing clots when blood thinners are already being used. This information will help doctors decide on the best and most comfortable way to prevent clots for patients like you in the future.

Key takeaways

Checks if stockings are needed with blood-thinning medicine after high-risk surgery.
Compares medicine plus stockings, versus medicine alone.
Aims to improve patient comfort and reduce unnecessary treatments.
Involves an extra ultrasound scan to check for clots.
Helps the NHS make informed decisions about clot prevention.
Participants will be followed up for about three months.

Who may be eligible?

This study is looking for adults aged 18 or older who are having planned surgery that puts them at a high risk of blood clots. Your doctor would have already decided that you need to take blood-thinning medicine for a longer time after your hospital stay to prevent these clots.

You wouldn't be able to join the study if you have certain medical conditions or if wearing the stockings or taking the blood-thinning medicine could be harmful for you. For example, if you're already taking blood thinners for a different reason, or if you have a known condition that makes your blood clot more easily, you wouldn't be eligible.

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.

Are you 18 years old or older?
Are you having planned surgery that makes you high-risk for blood clots?
Has your doctor already said you'll need blood-thinning medicine for a while after hospital?
Do you have any conditions that would stop you from taking blood thinners or wearing stockings?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, a computer will randomly assign you to one of two groups. One group will receive blood-thinning medicine and wear the special stockings while in hospital. The other group will receive the same blood-thinning medicine but will not wear the stockings. All other parts of your surgical care will remain exactly as they would normally.

After your operation, everyone in the study will have an extra ultrasound scan of their legs, usually between 3 and 5 weeks later, to check for any blood clots. This scan is not usually done for all patients in the NHS, so it's an extra check for you. You will also get phone calls at around 1 week, 3-5 weeks, and 3 months after your operation to see how you are doing and if you've had any problems or developed any clots. The total duration of active follow-up for the study will be about three months after your surgery.

Potential risks and benefits

Taking part in this study might mean you avoid uncomfortable stockings if you're in the group that doesn't wear them. However, if stockings do offer extra protection, then being in the group without them could mean a slightly higher, though still small, risk of developing a blood clot. If you are in the group that wears stockings, you might experience some discomfort or skin irritation. Please remember that you have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

North Bristol NHS Trust
Verified postcode
Bristol, United Kingdom· Recruiting
Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting
University College London NHS Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a blood clot (VTE)?

A blood clot (Venous Thromboembolism or VTE) is when blood thickens and forms a lump, usually in a deep vein in the leg (DVT). If it breaks off and travels to the lungs, it's called a pulmonary embolism (PE), which can be very serious.

Why is this study important?

This study will help doctors understand if special stockings give extra protection against blood clots after surgery, even when patients are already taking effective blood-thinning medicine. This could lead to better and more comfortable care for patients.

Will I still get blood-thinning medicine?

Yes, everyone in this study will receive blood-thinning medicine during their hospital stay and for a period after returning home. This is because you are at a higher risk of clots.

How will I know if I have a blood clot?

All participants will have an ultrasound scan of their legs after surgery to check for clots, and the study team will also call to check on you at various points.

What if I get blisters from the stockings?

If you are in the group wearing stockings and experience any problems like blisters or discomfort, you should tell your medical team immediately.

How to find out more

Alun H Davies

a.h.davies@imperial.ac.uk 0203 3117371 Official trial record

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