What About Use In Head Injuries?
Take Home: Our system’s trauma protocol suggests stopping TXA once there is a head injury discovered, BUT given this data, I wouldn’t be too worried that we had caused harm in the patient by giving TXA early.
— BMJ 2011
Design/Background: Essentially a small “nested” study within the CRASH II trial
Population: Patients in India and Columbia who met CRASH-II criterion (SBP<90, HR>110, likely transfusion) but also had:
- GCS of <14 and
- CT showing Brain Hemorrhage
Intervention and Control: Same as CRASH-II (TXA vs Placebo)
Primary Outcome: How much did the ICH grow on repeat CT scan at 24-48 hours?
Secondary Outcomes: multiple radiographic and patient outcomes
Results: 270 patients (133 allocated to tranexamic acid and 137 allocated to placebo) were recruited.
–>Non-significant benefit or harm, but TRENDING towards benefit (see below). This gives us hope, but really can’t be used in practice yet.
|How much did hemorrhage grow||5.9 mL||8.1 mL|
|Disabled at DC||22%||26%|
|Mass Effect observed on CT||47%||60%|
Given these results, a second study was done to try to prove good outcomes, but unfortunately they didn’t end up getting bigger numbers enrolled.
Tranexamic acid for patients with traumatic brain injury: a randomized, double-blinded, placebo-controlled trial.
— BMCC Emerg Med 2013
Design: Similar small numbers – 238 pts, GCS 4-12, <8 hrs after injury
Outcome: New or expanding ICH
Results: Worsening in 21 (18%) of 120 patients allocated to TXA and in 32 (27%) of 118 patients allocated to placebo. The difference was not statistically significant [RR = 0.65]
“TXA may reduce [intracranial hemorrhage progression] in patients with TBI; however, the difference was not statistically significant in this trial. Large clinical trials are needed to confirm and to assess the effect of TXA on death or disability after TBI.”
CRASH – 3
SO with 2 underpowered studies in the literature, in order to finally answer this question, Crash 3 is underway. Goal is 10,000 pts for ICH with TXA. 4065 enrolled so far.
Conclusion: TXA has not been shown benefit or harm in brain injured trauma patients. Larger studies are on the way.