Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tranexamic Acid 500 MG.
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intramuscular Tranexamic Acid for the Treatment of Symptomatic Mild Traumatic Brain Injury in Older Adults: a Randomised, Double-blind, Placebo-controlled Trial
Overview
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
Detailed description
TXA reduces bleeding by inhibiting the enzymatic breakdown of fibrin blood clots. Results from randomised trials (CRASH-3 and NCT01990768) show that early treatment with TXA (given intravenously) reduces head injury deaths (pooled RR 0.89, 95% CI 0.80-0.99). In the CRASH-3 trial, the reduction in head injury deaths with TXA was largest in patients with mild and moderate head injuries, particularly if patients were treated soon after injury. However, the CRASH-3 trial included mild TBI patients only if they had intracranial bleeding on CT scan. It is uncertain whether the results apply to mild TBI patients more generally. CRASH-4 is a randomised, double blind, placebo-controlled trial in symptomatic mild TBI in about 10,000 older adults. The pilot phase will include about 500 patients. The trial aims to provide reliable evidence about the effects of early intramuscular TXA on intracranial haemorrhage, disability, death, and dementia in older adults with symptomatic mild head injury.
Interventions
- Drug Tranexamic Acid 500 MG
given once as an intramuscular injection
Primary outcome measures
- Emergency department discharge [Time frame: within 24 hours]
Secondary outcome measures (12)
- Intracranial bleeding on CT scan [Time frame: within 48 hours]
- Head injury related death [Time frame: within 48 hours]
- All cause mortality [Time frame: within 28 days]
- Disability [Time frame: within 28 days]
- Global assessment of ability to self-care [Time frame: within 28 days]
- Neurosurgery [Time frame: within 28 days]
- Days in ICU [Time frame: within 28 days]
- Re-admission to hospital [Time frame: within 28 days]
- Vascular occlusive events [Time frame: within 28 days]
- Seizures [Time frame: within 28 days]
- Intramuscular injection site reaction [Time frame: within 28 days]
- Pneumonia [Time frame: within 28 days]
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:
- 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
Exclusion criteria
\- TXA not clearly indicated (e.g. major bleeding) or contraindicated (e.g. suspected stroke)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United Kingdom · 2 centers
- The Royal London Hospital — London
- St George's Hospital — London
Identifiers
NCT: NCT04521881 · 2020-KEP-456 · 2020-003391-40