E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intracerebral Haemorrhage |
Aivoverenvuoto |
|
E.1.1.1 | Medical condition in easily understood language |
Intracerebral Haemorrhage |
Aivoverenvuoto |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022751 |
E.1.2 | Term | Intracerebral bleed |
E.1.2 | System Organ Class | 100000004852 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068342 |
E.1.2 | Term | Intracerebral haematoma |
E.1.2 | System Organ Class | 100000004852 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022754 |
E.1.2 | Term | Intracerebral hemorrhage |
E.1.2 | System Organ Class | 100000004852 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022753 |
E.1.2 | Term | Intracerebral haemorrhage |
E.1.2 | System Organ Class | 100000004852 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068344 |
E.1.2 | Term | Intracerebral hematoma |
E.1.2 | System Organ Class | 100000004852 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the efficacy and safety of administration of intravenous tranexamic acid in patients with intracerebral haemorrhage within 2 hours of onset. |
|
E.2.2 | Secondary objectives of the trial |
To determine the efficacy and safety of administration of intravenous tranexamic acid in patients with intracerebral haemorrhage within 2 hours of onset. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients presenting with an acute ICH 2. Age ≥18 years 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Haematoma growth by 24±6 hours as defined by either ≥33% or ≥6ml increase from baseline |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24±6 hours post treatment initiation |
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E.5.2 | Secondary end point(s) |
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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
24±6 hours / 7 days / 90±7 days post treatment initiation |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
New Zealand |
Taiwan |
Vietnam |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |