STOP-MSU: Stopping Haemorrhage With Tranexamic Acid for Hyperacute Onset Presentation Including Mobile Stroke Units
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| ClinicalTrials.gov Identifier: NCT03385928 |
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Recruitment Status :
Recruiting
First Posted : December 29, 2017
Last Update Posted : August 3, 2021
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Sponsor:
Neuroscience Trials Australia
Collaborator:
The Florey Institute of Neuroscience and Mental Health
Information provided by (Responsible Party):
Neuroscience Trials Australia
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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 either intravenous tranexamic acid or placebo and will test the hypothesis that in patients with spontaneous ICH, treatment with tranexamic acid within 2 hours of onset will reduce haematoma expansion compared to placebo.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Intracerebral Haemorrhage | Drug: Tranexamic Acid Drug: Normal saline | Phase 2 |
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 80% power to detect a large effect size assuming mean relative ICH haematoma growth of 38% in the placebo arm compared to 19% in the active treatment arm and standard deviation of 19%, inflated for nonparametric analysis. Adaptive increase in sample size will be performed if the result of interim analysis of the first 144 patients is promising, using the methodology of Mehta and Pocock. The maximum sample size is capped at 326. Standard CT for initial diagnosis of suspected stroke patients will be performed. Neurological impairment and functional scores will be measured by a neurologist or health care professional trained in their administration. The assessors will be blinded to the treatment group. Patients eligible for the RCT will be randomised in a 1:1 ratio to receive either tranexamic acid or placebo stratified by treating centre and utilising randomly permuted blocks of random size.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 326 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | 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 either intravenous tranexamic acid or placebo. |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | STOP-MSU: Stopping Haemorrhage With Tranexamic Acid for Hyperacute Onset Presentation Including Mobile Stroke Units. A Phase II Randomised, Placebo-controlled, Investigator-driven Trial of Tranexamic Acid Within 2 Hours of Intracerebral Haemorrhage |
| Actual Study Start Date : | March 19, 2018 |
| Estimated Primary Completion Date : | December 1, 2023 |
| Estimated Study Completion Date : | March 1, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
COL4A1-related brain small-vessel disease
MedlinePlus related topics:
Bleeding
Drug Information available for:
Tranexamic acid
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Tranexamic acid
Intravenous tranexamic acid 1000 mg in 100 mL 0.9% NaCl (or in 50ml syringe with 0.9% NaCl) over 10 minutes followed by 1000 mg in 500 mL 0.9% NaCl infusion over 8 hours.
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Drug: Tranexamic Acid
Investigational product given within 2 hours of symptom onset |
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Placebo Comparator: Normal Saline (0.9% NaCl)
100 mls (or in 50ml syringe) intravenous 0.9%NaCl over 10 minutes followed by 500 ml intravenous 0.9% NaCl infusion over 8 hours.
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Drug: Normal saline
Placebo given within 2 hours of symptom onset
Other Name: 0.9%NaCl |
Primary Outcome Measures :
- Haematoma growth by 24±6 hours as defined by either ≥33%or ≥6ml increase from baseline ICH volume (mls) [ Time Frame: 24 hours(plus or minus 6 hours) ]Relative ICH haematoma growth
Secondary Outcome Measures :
- Haematoma growth by 24±6 hours as defined by ≥33%or ≥6ml increase from baseline in intracerebral haematoma volume, or any increase intraventricular haematoma volume [ Time Frame: 24 hours ±6 hours ]ICH or IVH growth at 24 hours ±6 hours from baseline
- Absolute haematoma growth by 24±6 hours [ Time Frame: 24 hours ±6 hours ]ICH growth as defined by either ≥33%or ≥6ml increase from baseline from baseline, adjusted for baseline ICH volume
- Relative haematoma growth by 24±6 hours [ Time Frame: 24 hour ±6 hours ]Relative ICH growth volume, adjusted for baseline ICH volume
- Absolute intraventricular haematoma growth by 24 hours ±6 hours [ Time Frame: 24 hours ±6 hours ]IVH growth at 24 hours ±6 hours from baseline
- Absolute intracerebral plus intraventricular haematoma growth by 24±6 hours [ Time Frame: 24 hours ±6 hours ]ICH plus IVH growth from baseline
- The number of patients with mRS 0-3 or back to pre-stroke level at 3 months [ Time Frame: 90 days ± 7 days ]mRS 0-3 or back to pre-stroke level at 3 months
- The number of patients with mRS 0-4 or back to pre-stroke level at 3 months [ Time Frame: 90 days ± 7 days ]mRS 0-4 or back to pre-stroke level at 3 months
- Categorical shift in mRS at 3 months [ Time Frame: 90 days ± 7 days ]mRS 0-4 or back to pre-stroke level, or mRS 0-3 or back to pre-stroke level (with lowest mRS score being the better outcome)
- Major thromboembolic events (myocardial infarction, ischaemic stroke, or pulmonary embolism) within 3 months [ Time Frame: 3 months from baseline ]Safety outcome
- Death within 3 months [ Time Frame: 3 months from baseline ]Safety outcome
- Death within 7 days [ Time Frame: 7 days from baseline ]Safety outcome
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 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, 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385928
Contacts
| Contact: Henry Zhao, MD | +61 3 9342 7000 | henry.zhao@mh.org.au | |
| Contact: Michele Sallaberger | 0438 471 423 | michele.sallaberger@florey.edu.au |
Locations
Show 22 study locations
Sponsors and Collaborators
Neuroscience Trials Australia
The Florey Institute of Neuroscience and Mental Health
Investigators
| Principal Investigator: | Geoffrey Donnan, MD | The Florey Institute of Neuroscience and Mental Health | |
| Principal Investigator: | Stephen Davis, MD | Melbourne Health Dept of Neurology & The University of Melbourne Dept of Medicine | |
| Principal Investigator: | Henry Zhao, MD | Melbourne Health Dept of Neurology & The University of Melbourne Dept of Medicine |
| Responsible Party: | Neuroscience Trials Australia |
| ClinicalTrials.gov Identifier: | NCT03385928 |
| Other Study ID Numbers: |
NTA1702 |
| First Posted: | December 29, 2017 Key Record Dates |
| Last Update Posted: | August 3, 2021 |
| Last Verified: | July 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Neuroscience Trials Australia:
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ICH Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular 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 |
Additional relevant MeSH terms:
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Cerebral Hemorrhage Hemorrhage Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Pathologic Processes Intracranial Hemorrhages Tranexamic Acid Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |