Traumatic Brain Injury Clinical Trials

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Intramuscular Tranexamic Acid for the Treatment of Symptomatic Mild Traumatic Brain Injury in Older Adults: a Randomised, Double-blind, Placebo-controlled Trial

Who is this study for? Patients with Traumatic Brain Injury
What treatments are being studied? Tranexamic Acid
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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:

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

⁃ 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

Locations
Other Locations
United Kingdom
St George's Hospital
RECRUITING
London
The Royal London Hospital
RECRUITING
London
Contact Information
Primary
Haleema Shakur-Still
Haleema.Shakur@lshtm.ac.uk
+4407714139500
Time Frame
Start Date: 2021-04-18
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 5000
Treatments
Active_comparator: Active
A single dose of Tranexamic acid 500mg given by intramuscular injection
Placebo_comparator: Placebo
One Injection of the placebo which is 10 mL Sodium Chloride (0.9%)
Sponsors
Leads: London School of Hygiene and Tropical Medicine

This content was sourced from clinicaltrials.gov