The CRASH-3 Trial has been published.
CRASH-2 demonstrated that early administration of tranexamic acid(within 3 hours of injury) reduced bleeding deaths by one third(1). In CRASH-3, the investigators looked at the effects of tranexamic acid in patients with potential traumatic brain injury.
The Trial
International, multi-centre, randomised, placebo-controlled trial
Big Trial
Eligibility criteria:
- Within 3 hours of injury
- GCS <12 or intracranial bleed on CT scan and
- No major extra cranial bleed
Primary Outcome: Head injury-related death in the hospital within 28 days in patients treated within 3 hours.
n = 4613 patient assigned to tranexamic acid and 4514 assigned to placebo.
Results/Comments:
- There was a reduction in head-injury related deaths in patients with mild(GCS of 13-15)-moderate head injury(RR 0.78 [95%CI 0.64-0.95]) when given within 3 hours of injury- these are large confidence intervals
- We need to remember that the sickest patients ie., the GCS 3, fixed dilated pupils were removed from this study.
- No clear evidence of reduction in death in those with severe injury (0.99[0.91-1.07])
- No evidence of adverse effects or complications, although the risk of deep venous thrombosis or pulmonary embolism was not captured in the study.
- Dose of tranexamic acid used was:
- loading dose of 1g over 10 minutes followed by
- IV infusion of 1g over 8 hours
My Take
- It’s safe
- It may result in decreased mortality in a particular subgroup: but not statistically significant
- It’s a discussion to have with the team as the results are not as compelling as CRASH 2.
- The real result will probably be that patients will get it as they will be getting it for their other trauma, regardless
- However for isolated intracranial trauma………..I’ll probably give it, if within 3 hours. But I’ll have a discussion with my surgeons well in advance, so we have a protocol.
What will you do?
References
The CRASH-2 Collaborators. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placeboocntrolled trial. Lancet 2010;376:23-32
