RecruitingPHASE4INTERVENTIONAL

THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)

This study, called THRIVE, is investigating a common health concern: blood clots after varicose vein operations. Varicose veins are enlarged veins near the skin's surface, and even with keyhole (endovenous) surgery, there's a small chance of blood clots forming in deeper leg veins. These clots can cause pain and swelling, and occasionally, serious lung problems. Doctors aren't sure if routinely giving blood-thinning medicines to everyone after these procedures is beneficial. This research aims to find out if medicines like Dalteparin, Tinzaparin, or Apixaban are effective at preventing these clots, helping improve safety for people undergoing varicose vein treatment.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Imperial College London

Enrolment target

3,175

Start

22 Jan 2024

Estimated completion

31 Dec 2027

Venous Thromboembolism Varicose Veins

What is this study about?

Varicose veins are a common problem where veins in your legs become swollen and twisted. They're usually not serious, but they can be uncomfortable and some people choose to have them treated. One common way to treat varicose veins is with keyhole surgery, called an endovenous intervention. This type of surgery involves going inside the vein to close it off, which helps improve blood flow.

While these operations are generally safe, treating varicose veins can sometimes slightly increase the risk of blood clots forming in the deeper veins of your leg. These deep vein clots, also known as deep vein thrombosis (DVT), can cause pain and swelling. In very rare cases, a piece of the clot can travel to the lungs, which can be a serious medical emergency. Currently, doctors aren't certain if giving medicines to thin the blood after these procedures is truly helpful for everyone in preventing these clots.

This study, called THRIVE, aims to answer that important question. We want to see if prescribing certain blood-thinning medicines after keyhole varicose vein surgery helps lower the chance of developing a blood clot. The study will look at several types of established blood-thinning drugs to see if they are beneficial and worth recommending routinely. By taking part, you could help us understand the best way to keep patients safe during and after their varicose vein treatment.

Key takeaways

The study investigates if blood-thinning drugs prevent clots after varicose vein keyhole surgery.
Varicose vein procedures carry a small risk of deep vein blood clots.
Medicines being tested are already approved blood thinners.
Your participation could help improve future safety for patients.
Participation involves taking medication and attending follow-up checks.

Who may be eligible?

To join this study, you need to be an adult over 18 years old and be scheduled to have a specific type of keyhole surgery for varicose veins. This surgery would be performed under local anaesthetic and can include various modern techniques like laser or foam treatments.

However, there are some reasons why you might not be able to take part. For example, if you already take blood-thinning medication for another health condition, or if you have a personal or close family history of blood clots, you wouldn't be eligible. Also, if you have certain blood disorders, allergies to the study medicines, or other major health problems like active cancer or severe kidney/liver issues, this study might not be suitable for you.

Pregnant women, people who have had a major surgery or trauma recently (in the last 3 months), or a recent stroke would also not be able to participate. It's important that you are able to understand and agree to take part in the study yourself.

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 over 18 years old?
Are you having keyhole surgery for varicose veins soon?
Do you currently take blood-thinning medication for another condition?
Have you or a close family member had blood clots before?
Are you currently pregnant or trying to get pregnant?
Do you have severe kidney or liver problems, or active cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the study, you would first have a full chat with the study team to make sure it's right for you. If you qualify, you'll be given one of the study medications, which are already approved blood-thinning drugs. These might be injections you give yourself, or tablets. The study team will explain exactly how and when to take your medication.

You'll have regular check-ups with the study team, which might include phone calls or visits to the clinic, to monitor your health and ensure the medicine is working safely. These visits are to track any side effects and to see if you develop any blood clots. The total duration of your participation, including medication and follow-up, will be clearly explained by the research team.

Potential risks and benefits

Taking part in a study like this could help us understand the best ways to care for people having varicose vein surgery in the future. While there's no guarantee of direct benefit for you personally, it could help improve safety for many patients. The main risk with blood-thinning medicines is an increased chance of bleeding or bruising. The study team will closely monitor you and explain all potential side effects. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Imperial College Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What are varicose veins?

Varicose veins are enlarged, twisted veins, often in the legs, that are close to the surface of the skin. They are caused by weak vein walls or faulty valves.

What is a 'keyhole' operation for varicose veins?

This is a modern way to treat varicose veins from inside the vein itself, often using things like lasers or radio waves, without needing large cuts on the skin.

What is a blood clot in this study?

The study is looking at clots in the deep veins of the leg (deep vein thrombosis or DVT) that can sometimes happen after varicose vein surgery.

Are the medicines in the study new?

No, the medicines used in this study are already approved and regularly used blood-thinning drugs. The study is checking if they are helpful in this particular situation.

Will I know which medicine I'm getting?

The study team will explain whether you will know which specific medicine you are receiving or if it will be randomly assigned, similar to how many trials work.

How to find out more

Sarah Whittley

s.whittley@imperial.ac.uk +442033117309 Official trial record

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