Clinical Trials List
2016-06-13 - 2020-12-31
Phase II
Terminated3
Study ended1
ICD-10I62
Other and unspecified nontraumatic intracranial hemorrhage
STOP-AUST: The Spot sign and Tranexamic acid On Preventing ICH growth – AUStralasia Trial
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Trial Applicant
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Sponsor
China Medical University Hospital/ The Florey Institute of Neuroscience and Mental Health
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
2 Study ended
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chih-Hung Chen Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
ICH growth by 24±3 hours as defined by either 33% or 6ml increase from baseline, adjusted for baseline ICH volume
2.Secondary endpoints:
Major thromboembolic events (myocardial infarction, ischaemic stroke, pulmonary embolism)
Absolute ICH growth volume by 24±3 hours, adjusted for baseline ICH volume
Absolute intraventricular haematoma (IVH) growth volume by 24±3 hours, adjusted for baseline IVH volume
mRS 0-4 or back to pre-stroke level at 3 months
mRS 0-3 or back to pre-stroke level at 3 months
Categorical shift in mRS at 3 months, subject to the validity of proportional odds assumption
Death due to any cause by 3 months
Inclution Criteria
(2) Contrast extravasation within the ICH, “spot sign” (for definition see chapter 5.3)
(3) Age ≥18 years
(4) 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)
(5) Informed consent has been received in accordance to local ethics committee requirements
Exclusion Criteria
(2) Brainstem ICH
(3) ICH volume >70 ml as measured by the ABC/2 method
(4) 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
(5) 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)
(6) 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.
(7) Hereditary or acquired haemorrhagic diathesis or coagulation factor deficiency.
(8) 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
(9) Pregnancy (women of childbearing potential must be tested)
(10) Planned surgery for ICH within 24 hours
(11) Concurrent or planned treatment with haemostatic agents (e.g. prothrombin complex concentrate, vitamin K, fresh frozen plasma, or platelet transfusion)
(12) Participation in any investigational study in the last 30 days
(13) Known terminal illness or planned withdrawal of care or comfort care measures.
(14) 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.
The Estimated Number of Participants
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Taiwan
60 participants
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Global
150 participants
