CRASH-4
Research type
Research Study
Full title
Intramuscular tranexamic acid for the treatment of symptomatic mild traumatic brain injury in older adults: a randomised, double-blind, placebo-controlled trial.
IRAS ID
283157
Contact name
Ian Roberts
Contact email
Sponsor organisation
London School of Hygiene & Tropical Medicine
Eudract number
2020-003391-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 8 months, 28 days
Research summary
Every year, over one million people in England and Wales suffer a mild Traumatic Brain Injury (TBI) needing hospital care. Bleeding into the brain is a common and serious complication of TBI and older adults are at highest risk. Even a small bleed into the brain can cause disability and some patients can die if the bleeding is more severe. We know that giving a drug called tranexamic acid as an infusion into the vein after a TBI reduces the chance of people dying due to bleeding into their brain (and the earlier it is given the better). We also know that tranexamic acid is rapidly available in the body after being injected into the muscle of trauma patients, without local side effects.
The CRASH-4 trial will assess if giving an early injection of tranexamic acid into the muscle of older adults after a mild TBI can prevent bleeding into the brain from starting in the first place and lead to better health outcomes.10,000 older adults (500 in the pilot phase) with mild TBI will be randomised to receive an injection of either 500mg tranexamic acid or matching placebo into the thigh, shoulder or bottom as soon as possible after injury but no later than 3 hours. The trial treatment will be given by paramedics before transport to hospital or by health care professionals in the Emergency Department otherwise.
Patient outcomes, including discharge from hospital, bleeding into the brain, death, measures of disability, patient management, re-admission to hospital and any reactions or adverse events, will be assessed in-hospital at discharge, death, or 28 days after randomisation, whichever occurs first. Where patients are discharged before day 28, readmission to hospital will be collected until day 28. We will assess the neurological impact of the TBI (dementia) at 1-year after randomisation by collecting data held by NHS Digital (for participants in England) or by NHS Wales Informatics Service (NWIS) (for participants in Wales).
If an early injection of tranexamic acid reduces death and disability in older adults with mild TBI this would be a major medical advance that would improve the care of many millions of patients world-wide.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
20/SC/0372
Date of REC Opinion
23 Oct 2020
REC opinion
Favourable Opinion