Status:
UNKNOWN
Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
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 w...
Detailed Description
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) redu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- \- TXA not clearly indicated (e.g. major bleeding) or contraindicated (e.g. suspected stroke)
Key Trial Info
Start Date :
April 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT04521881
Start Date
April 18 2021
End Date
March 31 2025
Last Update
January 5 2023
Active Locations (2)
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1
The Royal London Hospital
London, United Kingdom, E1 1FR
2
St George's Hospital
London, United Kingdom, SW17 0QT