Tranexamic acid in patients with intracerebral haemorrhage (STOP-AUST): a multicentre, randomised, placebo-controlled, phase 2 trial

SPS commentary:

The researchers call for larger trials of tranexamic acid, with simpler recruitment methods and an earlier treatment window.

An editorial discusses the lessons for future trials in patients with acute intracerebral haemorrhage, noting that the trialists took 6 years to recruit 100 participants in 13 centres; in part due to the requirement to obtain CT angiography and assess for a spot sign, which is not part of the routine care for these patients. It suggest the added value of this additional imaging is uncertain: even in those with a spot sign, only about half had haematoma growth, in line with findings from observational studies. In addition, previous small trials of rFVIIa also using the spot sign as a selection criterion did not show significant reductions in intracerebral haemorrhage growth either. Furthermore, TICH-2 showed no indication that the presence of a spot sign affected the response to tranexamic acid. It suggests that since baseline haematoma volume seems to be a key predictor of expansion, future trials could potentially select participants on the basis of this much simpler criterion. It concludes that future trials of haemostatic therapies in patients with acute intracerebral haemorrhage need to be large enough to detect a realistic clinically meaningful effect on haematoma expansion. They need to be simple (avoiding additional imaging to maximise recruitment and speed of administration) and exclude participants with either very small or very large volume intracerebral haemorrhage. It notes several tranexamic acid trials are currently underway and an individual patient data meta-analysis is also planned.