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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 : April 1, 2022
Sponsor:
Collaborator:
The Florey Institute of Neuroscience and Mental Health
Information provided by (Responsible Party):
Neuroscience Trials Australia

Tracking Information
First Submitted Date  ICMJE December 13, 2017
First Posted Date  ICMJE December 29, 2017
Last Update Posted Date April 1, 2022
Actual Study Start Date  ICMJE March 19, 2018
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2021)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
Relative ICH haematoma growth at 24±3 hours, adjusted for baseline ICH volume (mls) [ Time Frame: 24 hours(plus or minus 3 hours) ]
Relative ICH haematoma growth
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2021)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
  • ICH growth [ Time Frame: 24 hours (plus or minus 3 hours) ]
    ICH growth as defined by either 33% or 6ml increase from baseline, adjusted for baseline ICH volume
  • Absolute ICH growth (mls) [ Time Frame: 24 hours (plus or minus 3 hours) ]
    Absolute ICH growth
  • Relative ICH growth volume (mls) [ Time Frame: 1 hour after baseline CT ]
    Relative and absolute ICH growth volume, adjusted for baseline ICH volume
  • Major thromboembolic events [ Time Frame: 3 months ]
    Major thromboembolic events (myocardial infarction, ischaemic stroke, pulmonary embolism) or death
  • Intraventricular haematoma growth [ Time Frame: 24 hours (plus or minus 3 hours) ]
    Absolute intraventricular haematoma (IVH) growth volume adjusted for baseline IVH volume
  • Modified Rankin Scale (mRS) [ Time Frame: 3 months ]
    mRS 0-4 or back to pre-stroke level, or mRS 0-3 or back to pre-stroke level
  • mRS [ Time Frame: 3 months ]
    Categorical shift in mRS
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE STOP-MSU: Stopping Haemorrhage With Tranexamic Acid for Hyperacute Onset Presentation Including Mobile Stroke Units
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Intracerebral Haemorrhage
Intervention  ICMJE
  • Drug: Tranexamic Acid
    Investigational product given within 2 hours of symptom onset
  • Drug: Normal saline
    Placebo given within 2 hours of symptom onset
    Other Name: 0.9%NaCl
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Tranexamic Acid
  • 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.
    Intervention: Drug: Normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 10, 2021)
326
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2017)
62
Estimated Study Completion Date  ICMJE March 1, 2024
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Henry Zhao, MD +61 3 9342 7000 henry.zhao@mh.org.au
Contact: Michele Sallaberger 0438 471 423 michele.sallaberger@florey.edu.au
Listed Location Countries  ICMJE Australia,   Finland,   New Zealand,   Taiwan,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03385928
Other Study ID Numbers  ICMJE NTA1702
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Neuroscience Trials Australia
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Neuroscience Trials Australia
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE The Florey Institute of Neuroscience and Mental Health
Investigators  ICMJE
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
PRS Account Neuroscience Trials Australia
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP