2C. TXA in Head Injury?

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.


July5

— BMJ 2011

http://www.bmj.com/content/343/bmj.d3795.long

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.

TXA Placebo
How much did hemorrhage grow 5.9 mL 8.1 mL
Death 11% 18%
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

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4221638/

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]

Conclusions 

“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.

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