STOP-AUST: The Spot Sign and Tranexamic Acid On Preventing ICH Growth - AUStralasia Trial
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.
Inclusion Criteria:

 -  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:

 1. Serpiginous or spot-like appearance within the margin of a parenchymal haematoma
 without connection to an outside vessel;

 2. The density (in Hounsfield units) should be greater than that of the background
 haematoma (site investigators are not required to document the density); and

 3. 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

 Exclusion Criteria:

 -  Glasgow coma scale (GCS) total score of <8

 -  Brainstem ICH

 -  ICH volume >70 ml as measured by the ABC/2 method

 -  ICH known or suspected by study investigator to be secondary to trauma, aneurysm,
 vascular malformation, haemorrhagic transformation of ischaemic stroke, cerebral
 venous thrombosis, thrombolytic therapy, tumor, or infection

 -  Contrast already administered within 24 hours prior to initial CT or contraindication
 to imaging with CT contrast agents (e.g. known or suspected iodine allergy or
 significant renal failure)

 -  Any history or current evidence suggestive of venous or arterial thrombotic events
 within the previous 12 months, including clinical, ECG, laboratory, or imaging
 findings. Clinically silent chance findings of old ischemia are not considered
 exclusion.

 -  Hereditary or acquired haemorrhagic diathesis or coagulation factor deficiency.

 -  Use of heparin, low-molecular weight heparin, GPIIb/IIIa antagonist, or oral
 anticoagulation (e.g. warfarin, factor Xa inhibitor, thrombin inhibitor) within the
 previous 14 days, irrespective of laboratory values

 -  Pregnancy (women of childbearing potential must be tested)

 -  Planned surgery for ICH within 24 hours

 -  Concurrent or planned treatment with haemostatic agents (e.g. prothrombin complex
 concentrate, vitamin K, fresh frozen plasma, or platelet transfusion)

 -  Participation in any investigational study in the last 30 days

 -  Known terminal illness or planned withdrawal of care or comfort care measures.

 -  Any condition that, in the judgment of the investigator could impose hazards to the
 patient if study therapy is initiated or affect the participation of the patient in
 the study.