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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

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

Key facts

Study ID

NCT04521881

Run by

London School of Hygiene and Tropical Medicine

People needed

5000

Starts

2021-04-18

Expected to finish

2028-01-31

Last updated by the study team

2026-03-12

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• 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

You may not qualify if…

• TXA not clearly indicated (e.g. major bleeding) or contraindicated (e.g. suspected stroke)

Where it is running

• The Royal London Hospital — London, London, United Kingdom (enrolling)
• St George's Hospital — London, London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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