Clinical Trials List
Protocol NumberNTA1702
Completed
2019-06-01 - 2023-05-31
Phase II
Recruiting3
Stopping haemorrhage with Tranexamic acid for hyperacute Onset Presentation including Mobile Stroke Units
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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
Co-Principal Investigator
- 魏嵩泰 Division of Orthopedics
- 林宏霖 Division of Orthopedics
- Chun-Chung Chen Division of Orthopedics
- 陳賢修 Division of Orthopedics
- 李漢忠 Division of Orthopedics
Co-Principal Investigator
- SHIN-JOE YEH Division of Neurology
- SUNG-CHUN TANG Division of Neurology
- CHIH-HAO CHEN Division of Neurology
- 王國川 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Intracerebral haemorrhage (ICH)
Objectives
To determine the efficacy and safety of administration of intravenous tranexamic acid in patients with intracerebral haemorrhage within 2 hours of onset.
Test Drug
Tranexamic acid
Active Ingredient
Dosage Form
Injection
Dosage
Intravenous tranexamic acid or placebo 1000mg in 100 mL 0.9% NaCl over 10 minutes
followed by 1000 mg in 500 mL 0.9% NaCl infusion over 8 hours.
followed by 1000 mg in 500 mL 0.9% NaCl infusion over 8 hours.
Endpoints
1. Primary outcome:
• Haematoma growth by 24±6 hours as defined by either ≥33% or ≥6ml increase from
baseline.
2. Secondary outcomes:
Efficacy:
• Absolute haematoma growth by 24±6 hours
• Relative haematoma growth by 24±6 hours
• Absolute intraventricular haematoma growth by 24±6 hours
• mRS 0-3 or back to pre-stroke level at 3 months
• mRS 0-4 or back to pre-stroke level at 3 months
• Categorical shift in mRS at 3 months
Safety:
• Major thromboembolic events (myocardial infarction,ischaemic stroke, or pulmonary embolism)
within 3 months
• Death within 3 months
• Death within 7 days
• Haematoma growth by 24±6 hours as defined by either ≥33% or ≥6ml increase from
baseline.
2. Secondary outcomes:
Efficacy:
• Absolute haematoma growth by 24±6 hours
• Relative haematoma growth by 24±6 hours
• Absolute intraventricular haematoma growth by 24±6 hours
• mRS 0-3 or back to pre-stroke level at 3 months
• mRS 0-4 or back to pre-stroke level at 3 months
• Categorical shift in mRS at 3 months
Safety:
• Major thromboembolic events (myocardial infarction,ischaemic stroke, or pulmonary embolism)
within 3 months
• Death within 3 months
• Death within 7 days
Inclution Criteria
(1) Patients presenting with an acute ICH
(2) Age ≥20 years (For Taiwan)
(3) Treatment can commence within 2 hours of symptom onset (or in patients with unknown time of symptom onset, the time patient was last known to be well)
(4) Consent can be obtained from participant or person responsible. When emergency treatment procedures have been followed (where permittable) the participant or person responsible will be asked for consent to continue in the study.
(2) Age ≥20 years (For Taiwan)
(3) Treatment can commence within 2 hours of symptom onset (or in patients with unknown time of symptom onset, the time patient was last known to be well)
(4) Consent can be obtained from participant or person responsible. When emergency treatment procedures have been followed (where permittable) the participant or person responsible will be asked for consent to continue in the study.
Exclusion Criteria
(1) Glasgow coma scale (GCS) total score of <8
(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, tumour, or infection
(5) 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.
(6) Hereditary or acquired haemorrhagic diathesis or coagulation factor deficiency.
(7) Use of heparin, low-molecular weight heparin, GPIIb/IIIa antagonist, or oral anticoagulation (e.g. warfarin/vitamin K antagonists, factor Xa inhibitor, thrombin inhibitor) within the previous 72 hours. Warfarin/vitamin K antagonists must also have an INR of <1.3 prior to randomisation.
(8) Pregnancy (women of childbearing potential must be tested)
(9) Planned surgery for ICH within 24 hours
(10) Concurrent or planned treatment with haemostatic agents (e.g. prothrombin complex concentrate, vitamin K, fresh frozen plasma, or platelet transfusion)
(11) Participation in any investigational study in the last 30 days
(12) Known terminal illness or planned withdrawal of care or comfort care measures.
(13) 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.
(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, tumour, or infection
(5) 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.
(6) Hereditary or acquired haemorrhagic diathesis or coagulation factor deficiency.
(7) Use of heparin, low-molecular weight heparin, GPIIb/IIIa antagonist, or oral anticoagulation (e.g. warfarin/vitamin K antagonists, factor Xa inhibitor, thrombin inhibitor) within the previous 72 hours. Warfarin/vitamin K antagonists must also have an INR of <1.3 prior to randomisation.
(8) Pregnancy (women of childbearing potential must be tested)
(9) Planned surgery for ICH within 24 hours
(10) Concurrent or planned treatment with haemostatic agents (e.g. prothrombin complex concentrate, vitamin K, fresh frozen plasma, or platelet transfusion)
(11) Participation in any investigational study in the last 30 days
(12) Known terminal illness or planned withdrawal of care or comfort care measures.
(13) 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
30 participants
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Global
326 participants
