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

Traumatic Brain Injury

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