Title
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.
Phase
Phase 2Lead Sponsor
Neuroscience Trials AustraliaStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Intracerebral Haemorrhage StrokeIntervention/Treatment
tranexamic acid ...Study Participants
100The 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.
Intravenous placebo in 100 mL 0.9% NaCl over 10 minutes followed by 500 mL 0.9% NaCl infusion over 8 hours.
Intravenous tranexamic acid 1000 mg in 100 mL 0.9% NaCl over 10 minutes followed by 1000 mg in 500 mL 0.9% NaCl infusion over 8 hours.
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: 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 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.