RECRUITINGPhase 3INTERVENTIONAL
Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults
Intramuscular Tranexamic Acid for the Treatment of Symptomatic Mild Traumatic Brain Injury in Older Adults: a Randomised, Double-blind, Placebo-controlled Trial
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
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
\- TXA not clearly indicated (e.g. major bleeding) or contraindicated (e.g. suspected stroke)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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)
Treatments Being Tested
DRUG
Tranexamic Acid 500 MG
given once as an intramuscular injection
Locations (2)
The Royal London Hospital
London, London, United Kingdom
St George's Hospital
London, London, United Kingdom