At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Tranexamic Acid 500 MG (drug)
- How long the study runs
- Study runs about 81 months (dates as stated)
- About the drug or intervention
- Tranexamic Acid 500 MG — drug: given once as an intramuscular injection
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 50 Years and over
- Who
- All
- Number of participants
- 5,000
- Started
- 2021-04-18
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for traumatic brain injury
- • Phase3 - 5,000 participants
- • Tranexamic acid (TXA) reduces head injury deaths
Who can take part?
- • Ages 50 Years and over
- • Diagnosed with traumatic brain injury
Where?
- • London - The Royal London Hospital
- • London - St George's Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Tranexamic acid (TXA) reduces head injury deaths. The CRASH-4 trial aims to assess the effects of early intramuscular TXA on intracranial haemorrhage, disability, death, and dementia in older adults with symptomatic mild head injury
More detail
TXA reduces bleeding by inhibiting the enzymatic breakdown of fibrin blood clots. Results from randomised trials (CRASH-3 and NCT01990768) show that early treatment with TXA (given intravenously) reduces head injury deaths (pooled RR 0.89, 95% CI 0.80-0.99). In the CRASH-3 trial, the reduction in head injury deaths with TXA was largest in patients with mild and moderate head injuries, particularly if patients were treated soon after injury. However, the CRASH-3 trial included mild TBI patients only if they had intracranial bleeding on CT scan. It is uncertain whether the results apply to mild TBI patients more generally. CRASH-4 is a randomised, double blind, placebo-controlled trial in symptomatic mild TBI in about 10,000 older adults. The pilot phase will include about 500 patients. The trial aims to provide reliable evidence about the effects of early intramuscular TXA on intracranial haemorrhage, disability, death, and dementia in older adults with symptomatic mild head injury.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 50 Years and over
- Who can join: All genders
What the study is looking for
- ✓50 years or older (actual or estimated)
- ✓History or evidence of head injury (e.g. laceration, bruise, swelling or pain in head or face)
- ✓GCS ≥ 13
- ✓Has one or more of the following:
- ✓has or had any impaired consciousness (loss of consciousness, amnesia, or confusion)
Who cannot take part
- ✗\- TXA not clearly indicated (e.g. major bleeding) or not safe to use (e.g. suspected stroke)
See the full criteria
Where Is This Study? (2 UK sites)
The Royal London Hospital
London E1 1FR, United Kingdom
St George's Hospital
London SW17 0QT, United Kingdom
How to Get in Touch
Haleema Shakur-Still
Sponsor contactCONTACT