Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults

Last updated: January 4, 2023
Sponsor: London School of Hygiene and Tropical Medicine
Overall Status: Active - Recruiting

Phase

3

Condition

Traumatic Brain Injury

Memory Loss

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT04521881
2020-KEP-456
2020-003391-40
  • Ages > 50
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 50 years or older (actual or estimated)
  • History or evidence of head injury (e.g. laceration, bruise, swelling or pain in heador face)
  • GCS ≥ 13
  • Has one or more of the following:
  1. has or had any impaired consciousness (loss of consciousness, amnesia, orconfusion)
  2. nausea or vomiting
  • Within 3 hours of injury (do not include if interval cannot be estimated e.g. patientunable to confirm time of fall or patient found on floor after an unwitnessed fall andhome 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

Exclusion Criteria:

  • TXA not clearly indicated (e.g. major bleeding) or contraindicated (e.g. suspectedstroke)

Study Design

Total Participants: 10000
Study Start date:
April 18, 2021
Estimated Completion Date:
March 31, 2025

Study 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) reduces head injury deaths (pooled RR 0.89, 95% CI 0.80-0.99). In the CRASH-3 trial, the reduction in head injury deaths with TXA was largest in patients with mild and moderate head injuries, particularly if patients were treated soon after injury. However, the CRASH-3 trial included mild TBI patients only if they had intracranial bleeding on CT scan. It is uncertain whether the results apply to mild TBI patients more generally. CRASH-4 is a randomised, double blind, placebo-controlled trial in symptomatic mild TBI in about 10,000 older adults. The pilot phase will include about 500 patients. The trial aims to provide reliable evidence about the effects of early intramuscular TXA on intracranial haemorrhage, disability, death, and dementia in older adults with symptomatic mild head injury.

Connect with a study center

  • St George's Hospital

    London, SW17 0QT
    United Kingdom

    Active - Recruiting

  • The Royal London Hospital

    London, E1 1FR
    United Kingdom

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.