RecruitingPHASE3INTERVENTIONAL

Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults

The CRASH-4 study is investigating an important medicine called tranexamic acid, or TXA, for older adults who have experienced a mild head injury. Previous research suggests TXA can help reduce deaths from head injuries, especially if given early. This new study aims to understand if TXA can also help older adults with mild head injuries avoid problems like bleeding inside the skull, long-lasting difficulties, memory or thinking issues, and even death. It specifically looks at people aged 50 and over who have symptoms after a head knock. Researchers are hoping to get clearer answers on whether this treatment, given as an injection, can improve outcomes for a wider group of older patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

London School of Hygiene and Tropical Medicine

Enrolment target

5,000

Start

18 Apr 2021

Estimated completion

31 Jan 2028

Traumatic Brain Injury

What is this study about?

This study, called CRASH-4, is looking into a medicine named tranexamic acid, or TXA. You might hear it called TXA for short. This medicine is already known to help stop bleeding. Doctors usually use it to help blood clot, which can be really important in emergencies.

Previous studies have hinted that TXA could be very helpful for people who have had a head injury, by reducing the risk of dying. It seemed to work best when given soon after the injury, especially for those with mild to moderate head injuries. The CRASH-4 trial wants to take a closer look, focusing specifically on older adults (aged 50 and over) who have had a mild head injury and are showing symptoms like confusion or feeling sick. They want to see if giving TXA helps prevent serious problems down the line.

The main goal is to find out if giving TXA early can stop bleeding in the brain, reduce long-term problems like disability, memory and thinking difficulties, and ultimately prevent deaths in this group of patients. It's a large study, involving many people, to make sure the results are as reliable as possible and can truly help improve care for older adults after a mild head injury.

Key takeaways

The study is called CRASH-4 and looks at treatment for mild head injuries.
It focuses on older adults (aged 50 and over).
The medicine being tested is called tranexamic acid (TXA), which helps blood clot.
The aim is to see if TXA reduces bleeding in the brain, disability, thinking problems, and death.
You would receive an injection of either TXA or a dummy medicine within 3 hours of your injury.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you would generally need to be 50 years old or older and have had a head injury, even if it seems mild. This head injury might have caused things like a cut, bruise, or swelling on your head, or pain. Importantly, you would need to have had some symptoms of the injury, such as a brief loss of awareness, feeling confused, or experiencing sickness.

Also, the injury must have happened within the last three hours, and you shouldn't be living in a care home, mental health hospital, or prison. You would also need to be going to, or already be in, one of the hospitals taking part in the study.

There are also some reasons why you might not be able to join. For example, if TXA wouldn't be suitable for you because of another medical condition you have, or if you have certain other serious medical issues like a suspected stroke. Your doctors will check all these carefully.

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 50 years old or older?
Did you have a head injury recently (within the last 3 hours)?
Did your head injury cause symptoms like feeling confused, sick, or a brief loss of awareness?
Are you currently in a hospital or being taken to one that is part of this study?
Do you live in your own home (not a care home, mental health institution, or prison)?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive an injection of either the study medicine (TXA) or a dummy medicine (placebo), which looks exactly the same, soon after your head injury. You won't know which one you've received, and neither will the doctors treating you, unless there's an emergency. This is to make sure the results are fair.

After getting the injection, doctors and nurses will continue to monitor you closely as part of your usual care. There might be some standard tests and checks, but the study itself doesn't involve many extra visits. The research team will primarily be checking your health outcomes, such as how well you recover from your head injury, any long-term effects on your memory or thinking, and your overall well-being. The total duration of your involvement in terms of follow-up for the study will be explained by the research team.

Potential risks and benefits

Taking part in a study like this always has potential benefits and risks. Previous research suggests that TXA could reduce serious problems like bleeding and death after head injuries. However, we don't yet know for sure if it will have these benefits for all people with mild head injuries, particularly older adults, which is why this study is being done. There are also potential risks with any medication; while TXA is generally safe, your doctors will carefully consider if it's right for you based on your health. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

The Royal London Hospital
Verified postcode
London, United Kingdom· Recruiting
St George's Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is tranexamic acid (TXA)?

TXA is a medicine that helps your blood clot, which can stop bleeding. It's used in many medical situations where bleeding needs to be controlled.

Why is this study only for older adults?

Older adults can sometimes react differently to head injuries, and their recovery might be different. This study wants to specifically see if TXA helps people aged 50 and over with mild head injuries.

Will I know if I'm getting the real medicine?

No, you won't know. You will receive either TXA or a dummy medicine (placebo). This is a common practice in studies to make sure the results are unbiased.

What happens if I receive the dummy medicine?

You'll still receive all the usual medical care appropriate for your head injury. The study is designed to compare outcomes between those who receive TXA and those who don't, to understand its effect.

Can I leave the study once I've started?

Yes, you can choose to leave the study at any point. Your decision will not affect the medical care you receive.

How to find out more

Haleema Shakur-Still

Haleema.Shakur@lshtm.ac.uk +4407714139500 Official trial record

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