Early intramuscular tranexamic acid for older adults with mild head injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.