RecruitingPHASE3INTERVENTIONAL

Thromboprophylaxis in Lower Limb Immobilisation

If you've had a leg injury and are in a cast or splint, you might be at higher risk of blood clots. This study, called TiLLI, is looking for better ways to prevent these clots. It has two main goals: Firstly, for people at high risk of clots, it compares anti-clotting tablets to the usual injections to see if tablets work just as well. Secondly, for people at lower risk, it investigates if giving any medication is better than just offering advice. Participants will be grouped by their risk level (high or low) and then receive either tablets, injections, or no medication (for low-risk only). The study will track participants for 90 days to see how well these approaches work and if there are any side effects.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Queen Mary University of London

Enrolment target

10,044

Start

12 Nov 2024

Estimated completion

31 Aug 2028

Thrombosis Injury Leg

What is this study about?

When you injure your leg and it needs to be put in a plaster cast or splint, your risk of developing a blood clot in your leg increases. These clots can sometimes cause ongoing problems in your leg, or even move to your lungs, which can be very serious. Currently, over 70,000 people in the UK each year find themselves in this situation. While medicines can help prevent clots, these same medicines can also increase your risk of bleeding.

For people who are at a higher risk of blood clots, doctors often prescribe daily injections. However, these injections can be uncomfortable and sometimes difficult to give yourself. There are also anti-clotting tablets available that work well for other health conditions, but we don't yet know if they are as effective as injections for people with leg injuries. For those at a lower risk of clots, it's unclear if any medication is truly beneficial. This study aims to answer these important questions to help improve future care.

The TiLLI study is divided into two parts: TiLLI-High and TiLLI-Low. If you've recently had a leg injury and are in a cast or splint, and you decide to take part, you'll first be assessed to see if you're at a high or low risk of clots. If you're at high risk (TiLLI-High), you'll either receive anti-clotting tablets or injections. If you're at low risk (TiLLI-Low), you might receive tablets, injections, or no medication at all. You and your doctor will know which treatment you are receiving. All participants will get clear information on what to look out for if a clot occurs and how to manage their medication.

Key takeaways

This study compares anti-clotting tablets vs. injections after a leg injury with a cast or splint.
It also checks if any medication helps those at lower risk of clots.
Participants are either at high or low risk of developing clots.
Treatments last for up to 42 days, or until your cast comes off.
You'll be followed for 90 days to monitor for clots or side effects.
The goal is to find safer and more patient-friendly ways to prevent clots.

Who may be eligible?

This study is looking for people aged 16 or older who have recently (within the last 7 days) injured their leg and are now wearing a plaster cast or a firm support (brace).

You wouldn't be able to join the study if you need to stay in hospital for more than two days directly after your injury. Also, if you have certain health conditions that mean you can't safely take blood-thinning medicines, or if you're pregnant, trying to get pregnant, or breastfeeding, you wouldn't be eligible. If you've already been taking blood-thinning medication for more than three days, or if your leg support isn't a rigid cast or brace (like just a bandage), you also can't take part.

Finally, if you've already been in this specific study before, are unable to give consent, or are taking part in another trial that involves blood-thinning medication, you wouldn't be able to join. For women who could become pregnant and are assigned to certain tablet treatments, being unable or unwilling to use reliable contraception would also prevent participation.

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 16 years old or older?
Did you injure your leg and get a plaster cast or hard brace within the last 7 days?
Do you NOT need to stay in hospital for more than two days right after your injury?
Are you NOT pregnant and not breastfeeding?
Have you NOT already taken blood-thinning medication for more than 3 days?
Is your leg support a rigid cast or brace, not just a bandage?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have an assessment to determine your blood clot risk. Depending on your risk (high or low), you'll then be randomly assigned to one of the treatment groups: anti-clotting tablets, anti-clotting injections, or for those at low risk, potentially no medication. You'll take the assigned medication (if any) for as long as you're in your cast or splint, up to a maximum of 42 days.

You'll receive guidance on how to take your medication and what signs of blood clots or side effects to look out for. The research team will collect information from you over a period of 90 days after you join the study. This will help them understand if you developed any blood clots or experienced any problems from the medication. You won't need many extra visits beyond your usual medical appointments for your injury, as a lot of the information can be collected remotely or during routine care.

Potential risks and benefits

By taking part, you could help doctors understand the best ways to prevent serious blood clots after a leg injury. This could lead to better and more comfortable treatments for many people in the future. However, like all medications, the anti-clotting treatments in this study can have side effects, mainly an increased risk of bleeding. The study team will closely monitor you for any such effects. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (3)

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

Epsom and St Helier University Hospitals NHS Trust
Verified postcode
Carshalton, United Kingdom· Recruiting
Barts Health NHS Trust
Verified postcode
London, United Kingdom· Recruiting
Northern Care Alliance NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is a blood clot?

A blood clot is a thick, jelly-like clump of blood. When it forms in a deep vein, usually in your leg, it's called a DVT (deep vein thrombosis). These can be serious.

Why do leg injuries increase the risk of clots?

When your leg is injured and held still in a cast or splint, blood flow can slow down, making it easier for clots to form.

What's the main difference between tablets and injections?

Currently, injections are common for high-risk patients, but they can be uncomfortable. This study is checking if easier-to-take tablets work just as well.

How long will I be followed up after treatment?

The study team will keep in touch and collect information from you for 90 days after you start the study to see how you're doing.

Will I know which treatment I'm getting?

Yes, both you and your doctor will know whether you are receiving tablets, injections, or no medication.

How to find out more

Trial Manager

tilli-bjh@qmul.ac.uk +44 (0) 20 7882 5555 Official trial record

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