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Tranexamic Acid for Mild Head Injury in Older Adults

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

Recruiting Phase 3 Interventional Study
Traumatic Brain Injury
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
50 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
5,000 (estimated)
Sponsor
London School of Hygiene and Tropical Medicine · Other
Who this trial is looking for

This trial is looking for older adults who have recently experienced a mild head injury. Participants will receive a treatment to see if it helps reduce complications like bleeding and disability.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am 50 years or older
  • I have a history or evidence of a head injury
  • I have a Glasgow Coma Scale score of 13 or higher
  • I have had impaired consciousness or nausea or vomiting
  • It has been less than 3 hours since my injury
  • I do not live in a nursing home, mental health institution, or prison
  • I will be taken to a participating hospital

You may not be able to join if

  • I have major bleeding or suspected stroke
  • I am unable to confirm the time of my injury

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

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

Trial Locations

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Eligibility 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) …
Contacts

Haleema Shakur-Still

+4407714139500

Haleema.Shakur@lshtm.ac.uk

CONTACT

NCT ID: NCT04521881 Source: ClinicalTrials.gov