Tranexamic acid to prevent brain bleeds could save thousands of lives
pharmafile | October 15, 2019 | News story | Research and Development |
A large controlled clinical trial has linked the early use of tranexamic acid to a small fall in the risk of death in patients who have suffered traumatic brain injury.
Tranexamic acid is an off-patent drug used in managing bleeding trauma patients. Previous studies have shown the benefits of the drug in that population but there is a lack of evidence on its use in traumatic brain injury (TBI) patients.
To address the gap in evidence, researchers enrolled 12,737 patients with TBI and randomised them to receive tranexamic acid or placebo. The trial began enrolling patients treated within eight hours of injury but cut the time window to three hours in the middle of the study in response to external data suggesting that tranexamic acid is ineffective when treatment is delayed.
Over 70% of participants were treated within three hours of suffering head trauma. Among this group 18.5% of patients who received tranexamic acid died as a result of head injuries in the 28 days after treatment compared to 19.8% in the placebo group.
The difference between the two groups was not of statistical significance. However the drug fared better in a prespecified subgroup analysis.
Among patients with mild to moderate TBI, the death rates in the tranexamic acid and control groups were 5.8% and 7.5% – a difference which is statistically significant.
Ian Roberts, Professor of Clinical Trials at the London School of Hygiene and Tropical Medicine, said in a statement: “This huge exciting new result shows that early treatment with [tranexamic acid] also cuts deaths from head injury. It’s an important breakthrough and the first neuroprotective drug for patients with head injury.”
Although to laymen, the difference may not seem very significant, this Lancet study used prespecified subgroups selected on a pathophysiological rationale, suggesting the findings of the tranexamic acid trial may be more reliable than other subgroup analyses.
The case for using tranexamic acid is further supported by the lack of any downside to doing so. A course of treatment in the UK costs around £6.20 and, while some studies have linked the drug to an increase in thromboembolic events, the TBI study found no difference in the rates of complications in the treatment and placebo groups.
It is currently estimated nearly 69 million people worldwide sustain a traumatic brain injury every year and so there is scope for small reductions to benefit a vast amount of people.
Nik Kiran
