Status:
COMPLETED
STOP-MSU: Stopping Haemorrhage With Tranexamic Acid for Hyperacute Onset Presentation Including Mobile Stroke Units
Lead Sponsor:
Neuroscience Trials Australia
Collaborating Sponsors:
The Florey Institute of Neuroscience and Mental Health
Conditions:
Intracerebral Haemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study is a prospective phase II randomised, double-blind, placebo-controlled investigator-driven trial in acute intracerebral haemorrhage patients. The study has 2 arms with 1:1 randomisation to e...
Detailed Description
The trial will include patients with acute spontaneous ICH, who are ≥18 years of age and are eligible for treatment within 2 hours of stroke onset. A sample size of 326 patients is calculated to give ...
Eligibility Criteria
Inclusion
- Patients presenting with an acute ICH
- Age ≥18 years
- 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)
- Consent can be obtained from participant or person responsible. When emergency treatment procedures have been followed the participant or person responsible will be asked for consent to continue in the study.
Exclusion
- 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, tumour, or infection
- 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 72 hours.
- 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.
Key Trial Info
Start Date :
March 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2023
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT03385928
Start Date
March 19 2018
End Date
May 28 2023
Last Update
September 28 2023
Active Locations (25)
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1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
2
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
3
John Hunter Hospital
New Lambton Heights, New South Wales, Australia, 2305
4
Sunshine Coast University Hospital
Birtinya, Queensland, Australia, 4575