Early intramuscular tranexamic acid for older adults with mild head injury
Intramuscular Tranexamic Acid for the Treatment of Symptomatic Mild Traumatic Brain Injury in Older Adults: a Randomised, Double-blind, Placebo-controlled Trial
This will test whether an early intramuscular injection of tranexamic acid can reduce brain bleeding, disability, death, and later dementia in people aged 50 and over with symptomatic mild head injury.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 5000 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | London School of Hygiene and Tropical Medicine Academic / other |
| Locations | 2 sites (London, London and 1 other locations) |
| Trial ID | NCT04521881 on ClinicalTrials.gov |
What this trial studies
CRASH-4 is a randomized, double-blind, placebo-controlled Phase 3 trial testing a single 500 mg intramuscular dose of tranexamic acid given within 3 hours of injury to symptomatic adults aged 50 and older with mild head injury (GCS ≥13). The full trial plans about 10,000 participants with a pilot phase of roughly 500 to establish feasibility. Key outcomes include intracranial haemorrhage, functional disability, death, and dementia measured during follow-up. The trial builds on prior evidence that early IV TXA can reduce head-injury deaths but extends investigation to a broader mild-TBI population and an intramuscular route suitable for early prehospital use.
Who should consider this trial
Good fit: Ideal candidates are people aged 50 or older with a symptomatic mild head injury (GCS ≥13) who can receive the injection within 3 hours of the injury and will be taken to or admitted at a participating hospital.
Not a fit: People with major bleeding or clear contraindications to TXA (for example suspected stroke), those living in nursing homes, or those injured more than 3 hours earlier or with unknown injury time are unlikely to benefit from this trial.
Why it matters
Potential benefit: If effective, this treatment could reduce intracranial bleeding, deaths, long-term disability, and dementia after mild head injury in older adults.
How similar studies have performed: Previous randomized trials, including CRASH-3, showed that early intravenous TXA reduced head-injury deaths—particularly in mild-to-moderate cases treated soon after injury—while intramuscular use in a broad mild-TBI older population remains less tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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: 1. has or had any impaired consciousness (loss of consciousness, amnesia, or confusion) 2. nausea or vomiting * Within 3 hours of injury (do not include if interval cannot be estimated e.g. patient unable to confirm time of fall or patient found on floor after an unwitnessed fall and home alone) * Not living in a nursing home, mental health institution or prison * Patient will be conveyed to or is admitted to a participating hospital Exclusion Criteria: \- TXA not clearly indicated (e.g. major bleeding) or contraindicated (e.g. suspected stroke)
Where this trial is running
London, London and 1 other locations
- The Royal London Hospital — London, London, United Kingdom (Recruiting)
- St George's Hospital — London, London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Haleema Shakur-Still
- Email: Haleema.Shakur@lshtm.ac.uk
- Phone: +4407714139500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.