Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370273
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-21
Brief Title:
Thromboprophylaxis in Lower Limb Immobilisation
Sponsor:
Queen Mary University of London
Organization:
Queen Mary University of London
Study Overview
Official Title:
Thromboprophylaxis in Lower Limb Immobilisation TiLLI a Multicentre Study Comprising Two Linked Open Label Phase III Randomised Controlled Trials Evaluating the Effectiveness and Cost Effectiveness of Different Methods of Pharmacological Prophylaxis for Patients With Temporary Lower Limb Immobilisation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TiLLI
Brief Summary:
The goal of this clinical trial is to find out the clinical and cost effectiveness of Thromboprophylaxis in participants who have been placed in a plaster cast or splint after injury
The main questions it aims to answer are
whether giving tablets to people at high risks of clots after a leg injury is as good as injections standard care
whether giving any medication after a leg injury is better than standard care advice only for people at low risk of clots
Participants will be assessed to be high risk TiLLI High or low risk TiLLI Low People who are at high risk of clots will have either tablets or injections to reduce their risk People at low risk will receive tablets injections or no medication
Drug treatments will be provided for the duration of immobilisation or up to 42 days whichever is earlier in accordance with current NICE guidelines The participants will be followed up for 90 days following randomisation
The main questions it aims to answer are
whether giving tablets to people at high risks of clots after a leg injury is as good as injections standard care
whether giving any medication after a leg injury is better than standard care advice only for people at low risk of clots
Participants will be assessed to be high risk TiLLI High or low risk TiLLI Low People who are at high risk of clots will have either tablets or injections to reduce their risk People at low risk will receive tablets injections or no medication
Drug treatments will be provided for the duration of immobilisation or up to 42 days whichever is earlier in accordance with current NICE guidelines The participants will be followed up for 90 days following randomisation
Detailed Description:
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 70000 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 20000 patients will be able to avoid injections and 15 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
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 20000 patients will be able to avoid injections and 15 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None