STOP-AUST: The Spot Sign and Tranexamic Acid On Preventing ICH Growth - AUStralasia Trial.
The aim of the study is to test if intracerebral haemorrhage (ICH) patients who have contrast extravasation on computed tomography angiography, the spot sign, have lower rates of haematoma growth when treated with tranexamic acid within 4.5 hours of stroke onset, compared to placebo.
• Patients presenting with an acute ICH
• Contrast extravasation within the haemorrhage, spot sign, evaluated from the CTA according to three criteria, all of which must be present:
‣ Serpiginous or spot-like appearance within the margin of a parenchymal haematoma without connection to an outside vessel;
⁃ The density (in Hounsfield units) should be greater than that of the background haematoma (site investigators are not required to document the density); and
⁃ No hyperdensity at the corresponding location on non-contrast CT.
• Age ≥18 years
• Treatment can commence within 1 hour of initial CT and within 4.5 hours of symptom onset (or in patients with unknown time of symptom onset, the time patient was last known to be well)
• Informed consent has been received in accordance to local ethics committee requirements