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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Study
Team
crash4@lshtm.ac.uk
Study
Team
crash4@lshtm.ac.uk
Miss
Emma
Austin
Emma.austin@lshtm.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Injuries to the head
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Every year, over one million people in England and Wales suffer a mild Traumatic Brain Injury (TBI) needing hospital care. Bleeding into the brain is a common and serious complication of TBI and older adults are at highest risk. Even a small bleed into the brain can cause disability and some patients can die if the bleeding is more severe. We know that giving a drug called tranexamic acid as an infusion into the vein after a TBI reduces the chance of people dying due to bleeding into their brain (and the earlier it is given the better). We also know that tranexamic acid is rapidly available in the body after being injected into the muscle of trauma patients, without local side effects.
The CRASH-4 trial will assess if giving an early injection of tranexamic acid into the muscle of older adults after a mild TBI can prevent bleeding into the brain from starting in the first place and lead to better health outcomes.
10,000 older adults (500 in the pilot phase) with mild TBI will be randomised to receive an injection of either 500mg tranexamic acid or matching placebo into the thigh, shoulder or bottom as soon as possible after injury but no later than 3 hours. The trial treatment will be given by paramedics before transport to hospital or by health care professionals in the Emergency Department otherwise.
Patient outcomes, including discharge from hospital, bleeding into the brain, death, measures of disability, patient management, re-admission to hospital and any reactions or adverse events, will be assessed in-hospital at discharge, death, or 28 days after randomisation, whichever occurs first. Where patients are discharged before day 28, readmission to hospital will be collected until day 28. We will assess the neurological impact of the TBI (dementia) at 1-year after randomisation by collecting data held by NHS Digital (for participants in England) or by NHS Wales Informatics Service (NWIS) (for participants in Wales).
If an early injection of tranexamic acid reduces death and disability in older adults with mild TBI this would be a major medical advance that would improve the care of many millions of patients world-wide.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
• Living in a nursing home, mental health institution or prison • TXA is clearly indicated (e.g. major bleeding) or contraindicated (e.g. suspected stroke) • Known to have a diagnosis of dementia
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Study
Team
crash4@lshtm.ac.uk
Study
Team
crash4@lshtm.ac.uk
Miss
Emma
Austin
Emma.austin@lshtm.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by London School of Hygiene and Tropical Medicine and funded by The Jon Moulton Charity Trust (Guernsey) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 47298
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
