RecruitingPhase 3NCT04521881
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
Sponsor
London School of Hygiene and Tropical Medicine
Enrollment
5,000 participants
Start Date
Apr 18, 2021
Study Type
INTERVENTIONAL
Conditions
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 with symptomatic mild head injury
Eligibility
Min Age: 50 Years
Inclusion Criteria9
- 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 Criteria1
- \- TXA not clearly indicated (e.g. major bleeding) or contraindicated (e.g. suspected stroke)
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Interventions
DRUGTranexamic Acid 500 MG
given once as an intramuscular injection
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04521881
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