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)

The Royal London Hospital

London, London, United Kingdom

St George's Hospital

London, London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04521881


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