Thromboprophylaxis in Lower Limb Immobilisation

People have an increased risk of blood clots when they have a leg injury treated with a plaster cast or a splint, which happens to over 70,000 people every year in the UK. Blood clots can cause long term problems in the legs and can also move to the lungs, causing serious illness and occasionally death. Medicines are available to reduce the risk of blood clots, but they can also increase the risk of bleeding. In people at high risk of clots, most hospitals use the recommended daily injections which can be uncomfortable and sometimes difficult to give. Tablets are available that reduce the risk of blood clots in other groups, but it is not known if tablets work as well as the injections for people with a leg injury. It is also not known whether people at low risk of blood clots may benefit from any medication. As such, a national research body has identified the need for further study on this topic.

The TiLLI study has two aims - to determine whether giving tablets to people at high risk of clots after a leg injury is as good as injections, and whether giving any medication is better than standard care (advice only) for people at low risk of clots.

The TiLLI study consists of two linked trials: TiLLI-High and TiLLI-Low. People who have been placed in a plaster cast or splint after a leg injury will be invited to participate. Those who agree and are at high risk of clots will enter TiLLI-High and be randomised to receive either tablets or injections to reduce their risk of blood clots; those at low risk will enter TiLLI-Low and will be randomised to receive tablets, injections, or no medication. Patients and doctors will know what medication they are taking. All patients will be provided with written guidance on the signs and symptoms of blood clots and advice on managing their medication.

Information will be collected from study participants up to 90 days after joining the study to find out whether anyone suffers blood clots or complications from the medication. This data will be collected by reviewing medical records and contacting participants as needed. To encourage people from different backgrounds to take part, the study will run from lots of different hospitals across the UK. Study materials will be translated into different languages for those who do not speak English. The investigators will collect as much information as possible from people without extra hospital visits. An independent panel will look at the data as the study progresses to decide whether it is safe to continue.

The study will cost approximately £300 per patient, which is excellent value for money. If these trials show that tablets are as effective as injections, approximately 20,000 patients will be able to avoid injections and \>£1.5 million will be released back to NHS resources, every year. When the study is finished, the investigators will share the findings with staff in the NHS, patient charities and national guideline bodies. They will also publish the findings in the medical press and work with international research groups to answer further research questions on this topic.

• Symptomatic VTE event occurrence [Срок оценки: Within 90 days from randomisation]
• Major bleeding occurrence [Срок оценки: Within 42 days from randomisation]
• Cause-specific mortality occurrence [Срок оценки: Within 90 days from randomisation]
• Adverse and Serious adverse events [Срок оценки: Within 90 days from randomisation.]
• Medication adherence [Срок оценки: Up to 42 days from randomisation]
• Health utility (EQ-5D-5L) [Срок оценки: Up to 90 days post randomisation.]
• Patient satisfaction regarding the burdens and benefits of anticoagulation [Срок оценки: Collected within 42 days following randomisation when the participants stops study treatment.]
• Hospital readmission/reattendance [Срок оценки: Within the first 90 days.]
• Health and social care resource use [Срок оценки: Within the first 90 days]
• Patient longer term outcome VTE and bleeding data [Срок оценки: Informed by directly measured events up to 90 days.]