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

Primary Purpose

Intracerebral Haemorrhage

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tranexamic Acid
Normal saline
Sponsored by
Neuroscience Trials Australia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Haemorrhage focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Prince Alfred Hospital
  • Liverpool Hospital
  • John Hunter Hospital
  • Sunshine Coast University Hospital
  • Gold Coast University Hospital
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Box Hill Hospital
  • Monash Medical Centre
  • St Vincent's Hospital Melbourne
  • University Hospital Geelong
  • Austin Hospital
  • Alfred Hospital
  • Royal Melbourne Hospital
  • Mobile Stroke Unit
  • Helsinki University Hospital
  • CDHB Christchurch Hospital
  • Palmerston North Hospital
  • Wellington Hospital
  • E-DA Hospital
  • China Medical University Hospital
  • National Taiwan University Hospital
  • Bach Mai Hospital
  • Military 103 Hospital
  • Nguyen Tri Phuong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tranexamic acid

Normal Saline (0.9% NaCl)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Haematoma growth by 24±6 hours as defined by either ≥33%or ≥6ml increase from baseline ICH volume (mls)
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
ICH or IVH growth at 24 hours ±6 hours from baseline
Absolute haematoma growth by 24±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
Relative ICH growth volume, adjusted for baseline ICH volume
Absolute intraventricular haematoma growth by 24 hours ±6 hours
IVH growth at 24 hours ±6 hours from baseline
Absolute intracerebral plus intraventricular haematoma growth by 24±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
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
mRS 0-4 or back to pre-stroke level at 3 months
Categorical shift in mRS at 3 months
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
Safety outcome
Death within 3 months
Safety outcome
Death within 7 days
Safety outcome

Full Information

First Posted
December 13, 2017
Last Updated
September 25, 2023
Sponsor
Neuroscience Trials Australia
Collaborators
The Florey Institute of Neuroscience and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT03385928
Brief Title
STOP-MSU: Stopping Haemorrhage With Tranexamic Acid for Hyperacute Onset Presentation Including Mobile Stroke Units
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 19, 2018 (Actual)
Primary Completion Date
May 28, 2023 (Actual)
Study Completion Date
May 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuroscience Trials Australia
Collaborators
The Florey Institute of Neuroscience and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Haemorrhage
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Normal Saline (0.9% NaCl)
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
Investigational product given within 2 hours of symptom onset
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
0.9%NaCl
Intervention Description
Placebo given within 2 hours of symptom onset
Primary Outcome Measure Information:
Title
Haematoma growth by 24±6 hours as defined by either ≥33%or ≥6ml increase from baseline ICH volume (mls)
Description
Relative ICH haematoma growth
Time Frame
24 hours(plus or minus 6 hours)
Secondary Outcome Measure Information:
Title
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
Description
ICH or IVH growth at 24 hours ±6 hours from baseline
Time Frame
24 hours ±6 hours
Title
Absolute haematoma growth by 24±6 hours
Description
ICH growth as defined by either ≥33%or ≥6ml increase from baseline from baseline, adjusted for baseline ICH volume
Time Frame
24 hours ±6 hours
Title
Relative haematoma growth by 24±6 hours
Description
Relative ICH growth volume, adjusted for baseline ICH volume
Time Frame
24 hour ±6 hours
Title
Absolute intraventricular haematoma growth by 24 hours ±6 hours
Description
IVH growth at 24 hours ±6 hours from baseline
Time Frame
24 hours ±6 hours
Title
Absolute intracerebral plus intraventricular haematoma growth by 24±6 hours
Description
ICH plus IVH growth from baseline
Time Frame
24 hours ±6 hours
Title
The number of patients with mRS 0-3 or back to pre-stroke level at 3 months
Description
mRS 0-3 or back to pre-stroke level at 3 months
Time Frame
90 days ± 7 days
Title
The number of patients with mRS 0-4 or back to pre-stroke level at 3 months
Description
mRS 0-4 or back to pre-stroke level at 3 months
Time Frame
90 days ± 7 days
Title
Categorical shift in mRS at 3 months
Description
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)
Time Frame
90 days ± 7 days
Title
Major thromboembolic events (myocardial infarction, ischaemic stroke, or pulmonary embolism) within 3 months
Description
Safety outcome
Time Frame
3 months from baseline
Title
Death within 3 months
Description
Safety outcome
Time Frame
3 months from baseline
Title
Death within 7 days
Description
Safety outcome
Time Frame
7 days from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey Donnan, MD
Organizational Affiliation
The Florey Institute of Neuroscience and Mental Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Davis, MD
Organizational Affiliation
Melbourne Health Dept of Neurology & The University of Melbourne Dept of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henry Zhao, MD
Organizational Affiliation
Melbourne Health Dept of Neurology & The University of Melbourne Dept of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Sunshine Coast University Hospital
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
University Hospital Geelong
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Mobile Stroke Unit
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Facility Name
CDHB Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8140
Country
New Zealand
Facility Name
Palmerston North Hospital
City
Palmerston North
ZIP/Postal Code
4442
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
E-DA Hospital
City
Kaohsiung City
State/Province
Yanchao District
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Bach Mai Hospital
City
Hanoi
Country
Vietnam
Facility Name
Military 103 Hospital
City
Hanoi
Country
Vietnam
Facility Name
Nguyen Tri Phuong Hospital
City
Ho Chi Minh City
Country
Vietnam

12. IPD Sharing Statement

Learn more about this trial

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

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