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

ConditionTraumatic Brain Injury
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorLondon School of Hygiene and Tropical Medicine

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tranexamic Acid 500 MG

    Drug

    given once as an intramuscular injection

Treatment groups

5,000 Participants
are divided into 2 treatment groups
Group A: ActiveActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Emergency department discharge

discharge

Time frame
within 24 hours

Secondary outcomes

1

Intracranial bleeding on CT scan

any bleeding on the last scan conducted within 48 hours of randomisation

Time frame
within 48 hours
2

Head injury related death

In-hospital head injury-related death within 48 hours of injury

Time frame
within 48 hours
3

All cause mortality

Cause of death will be described

Time frame
within 28 days
4

Disability

The Barthel scale will be used to assess functional disability

Time frame
within 28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

London School of Hygiene and Tropical Medicine

Lead sponsor

Source ClinicalTrials.gov
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