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

Study acronym: CRASH-4
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Enrollment target: 10000 to 5000v7 Show 4 more changesShow less
    • Primary completion date: Mar 31, 2024 to Dec 31, 2026
    • Study completion date: Mar 31, 2025 to Jan 31, 2028
    • Secondary endpoints: 14 to 15
    • Site details revised at 2 of 2 sites
  2. Site details revised at 1 of 2 sitesv6
  3. Re-verified, no change to tracked fieldsv5
  4. Eligibility criteria shortened, about 7 words
    • Collaborators shortened, about 3 words
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2021 to Apr 18, 2021
    • Site details revised at 2 of 2 sites
    v3
  6. Start date: Nov 1, 2020 to Apr 1, 2021v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT04521881
Lead Sponsor London School of Hygiene and Tropical Medicine
Conditions
(from sponsor)		 Traumatic Brain Injury
Related terms Brain Injuries, Traumatic
Enrollment 5,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov