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

• Status: Recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborator: J.P Moulton Foundation
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• 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:

1. has or had any impaired consciousness (loss of consciousness, amnesia, or confusion)

2. 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 Criteria:

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