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STOP-MSU: Stopping Haemorrhage With Tranexamic Acid for Hyperacute Onset Presentation Including Mobile Stroke Units

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ClinicalTrials.gov Identifier: NCT03385928
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : February 16, 2021
Sponsor:
Collaborator:
The Florey Institute of Neuroscience and Mental Health
Information provided by (Responsible Party):
Neuroscience Trials Australia

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

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 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.

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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 related topics: Bleeding

Arm Intervention/treatment
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.
Drug: Tranexamic Acid
Investigational product given within 2 hours of symptom onset

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.
Drug: Normal saline
Placebo given within 2 hours of symptom onset
Other Name: 0.9%NaCl




Primary Outcome Measures :
  1. 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 :
  1. Absolute haematoma growth by 24±6 hours [ Time Frame: 24 hours (plus or minus 6 hours) ]
    ICH growth as defined by either ≥33%or ≥6ml increase from baseline from baseline, adjusted for baseline ICH volume

  2. Relative haematoma growth by 24±6 hours [ Time Frame: 1 hour ±1 hour after baseline CT ]
    Relative ICH growth volume, adjusted for baseline ICH volume

  3. Absolute intraventricular haematoma growth by 24±6 hours [ Time Frame: 24 hours (plus or minus 6 hours) ]
    IVH growth from baseline

  4. 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

  5. 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

  6. 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)

  7. Major thromboembolic events (myocardial infarction, ischaemic stroke, or pulmonary embolism) within 3 months [ Time Frame: 3 months from baseline ]
    Safety outcome

  8. Death within 3 months [ Time Frame: 3 months from baseline ]
    Safety outcome

  9. Death within 7 days [ Time Frame: 7 days from baseline ]
    Safety outcome



Information from the National Library of Medicine

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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:

  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 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, factor Xa inhibitor, thrombin inhibitor) within the previous 72 hours.
  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.

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
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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 Show 19 study locations
Sponsors and Collaborators
Neuroscience Trials Australia
The Florey Institute of Neuroscience and Mental Health
Investigators
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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
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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: February 16, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neuroscience Trials Australia:
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