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

Study Overview
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Brief Summary
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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.

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

Conditions
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Intracerebral Haemorrhage, Stroke

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic Acid<br>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. | Drug: Tranexamic Acid<br> <br> |
| Placebo Comparator: Placebo<br>Intravenous placebo in 100 mL 0.9% NaCl over 10 minutes followed by 500 mL 0.9% NaCl infusion over 8 hours. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICH growth by 24±3 hours as defined by either 33% or 6 ml increase from baseline, adjusted for baseline ICH volume. |  | 24+/-3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major thromboembolic events (myocardial infarction, ischaemic stroke, pulmonary embolism) |  | Within 90+/-7 days | 
| Absolute ICH growth volume by 24±3 hours, adjusted for baseline ICH volume |  | 24+/-3 hours | 
| Absolute intraventricular haematoma (IVH) growth volume by 24±3 hours, adjusted for baseline IVH volume |  | 24+/-3 hours | 
| modified Rankin Scale (mRS) score of 0-4 at 3 months |  | 90+/-7 days | 
| modified Rankin Scale (mRS) score of 0-3 at 3 months |  | 90+/-7 days | 
| Categorical shift in mRS at 3 months, subject to the validity of proportional odds assumption |  | 90+/-7 days | 
| Death due to any cause by 3 months |  | within 90+/-7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular Diseases, Intracerebral Hemorrhage, ICH, Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Tranexamic Acid, Antifibrinolytic Agents, Fibrin Modulating Agents, Pharmacologic Actions, Cardiovascular Agents, Therapeutic Uses, Hematologic Agents, Hemostatics, Contrast Media, Angiography, Cerebral Angiography, Tomography, X-Ray Computed