Mechanism of action of tranexamic acid in isolated TBI v1.1
Research type
Research Study
Full title
Mechanism of action of tranexamic acid in isolated traumatic brain injury
IRAS ID
186446
Contact name
Sean Jennings
Contact email
Sponsor organisation
University of Birmingham
Clinicaltrials.gov Identifier
ISRCTN15088122, ISRCTN for parent CRASH-3 RCT; NCT01402882, ClinicalTrials.gov Identifier for parent CRASH-3 RCT; 2011-003669-14, Eudract number for parent CRASH-3 RCT; RRK5587, University Hospitals Birmingham NHS Foundation Trust; ERN_15-1213, University of Birmingham Project Reference; RG_15-194, University of Birmingham Sponsorship Reference (Research Governance)
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
CRASH-3 is a large international clinical trial which compares tranexamic acid (TXA) with a placebo in the initial treatment of traumatic brain injury (TBI). TXA is a safe and inexpensive drug which may help in TBI, partly by helping the blood to clot better and therefore reducing the amount of bleeding in the brain. However, there is some emerging evidence that it might also work by reducing the inflammation caused by TBI, or directly protect brain cells from dying.
The CRASH-3 data monitoring committee have looked at the results from the first 3000 patients (which are held privately to avoid biasing the study). Based on this, they have recommended that a new study be set up to investigate how TXA affects the injured brain. We are proposing a study which will measure the amounts of chemicals released by the brain after TBI, and then compare this between patients who were allocated to TXA versus placebo. These chemicals are measurable indicators of inflammation and brain cell damage. By performing a specialised multivariate statistical analysis on all of these chemicals, we hope to understand how TXA affects the way the brain reacts to an injury.
To measure these chemicals, we will need to perform a special technique called cerebral microdialysis (MD). MD involves inserting a very thin tube into the skull to sample chemicals released by the brain. This will happen while the patient is sedated in Intensive Care. MD is an established procedure and is routinely used in the centres participating in this study.
If our study shows a plausible effect of TXA upon inflammation or brain cell damage, this would mean that it might be useful for other patient groups e.g. TBI without bleeding, or other conditions involving brain inflammation or damage.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
15/EM/0544
Date of REC Opinion
18 Jan 2016
REC opinion
Further Information Favourable Opinion