Intracerebral HaemorrhagePhase 2NCT03385928
STOP-MSU: Stopping Haemorrhage With Tranexamic Acid for Hyperacute Onset Presentation Including Mobile Stroke Units
A Phase 2 study testing Tranexamic Acid and Normal saline in people with Intracerebral Haemorrhage, run by Neuroscience Trials Australia at 25 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Haemorrhage
- What is being tested?
- Tranexamic Acid and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 25 sitesin 5 countries
- Study dates
- 19 Mar 2018to 28 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
25 sites in 5 countries.
25 sites in 5 countries
Australia15 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
Box Hill Hospital
Box Hill, Victoria, 3128
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Monash Medical Centre
Clayton, Victoria, 3168
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
University Hospital Geelong
Geelong, Victoria, 3220
Austin Hospital
Heidelberg, Victoria, 3084
Liverpool Hospital
Liverpool, New South Wales, 2170
Alfred Hospital
Melbourne, Victoria, 3004
Royal Melbourne Hospital
Melbourne, Victoria
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Mobile Stroke Unit
Parkville, Victoria, 3050
Gold Coast University Hospital
Southport, Queensland, 4215
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
New Zealand3 sites
CDHB Christchurch Hospital
Christchurch, 8140
Palmerston North Hospital
Palmerston North, 4442
Wellington Hospital
Wellington, 6021
Taiwan3 sites
E-DA Hospital
Kaohsiung City, Yanchao District
China Medical University Hospital
Taichung, 40447
National Taiwan University Hospital
Taipei, 100
Vietnam3 sites
Bach Mai Hospital
Hanoi
Military 103 Hospital
Hanoi
Nguyen Tri Phuong Hospital
Ho Chi Minh City
About this study
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
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.
Read the 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.
- Conditions
- Intracerebral Haemorrhage
- Being tested
- Tranexamic Acid, Normal saline
- 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
- Medical subject headings
- Cerebral Hemorrhage, Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Investigational product given within 2 hours of symptom onset
Normal salineDrug
Also called 0.9%NaCl
Placebo given within 2 hours of symptom onset
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Active comparator | 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. Receives: Drug: Tranexamic Acid |
| Normal Saline (0.9% NaCl) | Placebo comparator | 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. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haematoma growth by 24±6 hours as defined by either ≥33%or ≥6ml increase from baseline ICH volume (mls)
Relative ICH haematoma growth
Measured: 24 hours(plus or minus 6 hours)
Secondary outcomes (11)
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
Measured: 24 hours ±6 hours
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
Measured: 24 hours ±6 hours
Relative haematoma growth by 24±6 hours
Relative ICH growth volume, adjusted for baseline ICH volume
Measured: 24 hour ±6 hours
Absolute intraventricular haematoma growth by 24 hours ±6 hours
IVH growth at 24 hours ±6 hours from baseline
Measured: 24 hours ±6 hours
Absolute intracerebral plus intraventricular haematoma growth by 24±6 hours
ICH plus IVH growth from baseline
Measured: 24 hours ±6 hours
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
Measured: 90 days ± 7 days
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
Measured: 90 days ± 7 days
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)
Measured: 90 days ± 7 days
Major thromboembolic events (myocardial infarction, ischaemic stroke, or pulmonary embolism) within 3 months
Safety outcome
Measured: 3 months from baseline
Death within 3 months
Safety outcome
Measured: 3 months from baseline
Death within 7 days
Safety outcome
Measured: 7 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start19 Mar 2018
- Primary completion28 May 2023
- Study completion28 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HaemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuroscience Trials Australia
- Sponsor type
- University, hospital or other
- Collaborators
- The Florey Institute of Neuroscience and Mental Health
- Responsible party
- Sponsor
- Investigators
- Geoffrey Donnan, MD, Principal investigator, The Florey Institute of Neuroscience and Mental HealthStephen Davis, MD, Principal investigator, Melbourne Health Dept of Neurology & The University of Melbourne Dept of MedicineHenry Zhao, MD, Principal investigator, Melbourne Health Dept of Neurology & The University of Melbourne Dept of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385928
- Sponsor's protocol ID
- NTA1702
- Status last verified
- Sep 2023
- First submitted
- 13 Dec 2017
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yassi N, Zhao H, Churilov L, Wu TY, Ma H, Nguyen HT, Cheung A, Meretoja A, Mai DT, Kleinig T, Jeng JS, Choi PMC, Duc PD, Brown H, Ranta A, Spratt N, Cloud GC, Wang HK, Grimley R, Mahawish K, Cho DY, Shah D, Nguyen TMP, Sharma G, Yogendrakumar V, Yan B, Harrison EL, Devlin M, Cordato D, Martinez-Majander N, Strbian D, Thijs V, Sanders LM, Anderson D, Parsons MW, Campbell BCV, Donnan GA, Davis SM; STOP-MSU Trial Investigators. Tranexamic acid versus placebo in individuals with intracerebral haemorrhage treated within 2 h of symptom onset (STOP-MSU): an international, double-blind, randomised, phase 2 trial. Lancet Neurol. 2024 Jun;23(6):577-587. doi: 10.1016/S1474-4422(24)00128-5. Epub 2024 Apr 20.
PubMed 38648814Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.
PubMed 37870112
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03385928
- Acronym / sponsor ID
- NTA1702
- Conditions
- Intracerebral Haemorrhage
- Keywords
- ICH, Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Neuroscience Trials AustraliaUniversity, hospital or other
- Collaborators
- The Florey Institute of Neuroscience and Mental Health
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 28 May 2023 (actual)
- Study completion
- 28 May 2023 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Active comparator | Drug: Tranexamic AcidIntravenous 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. |
| Normal Saline (0.9% NaCl) | Placebo comparator | Drug: Normal saline100 mls (or in 50ml syringe) intravenous 0.9%NaCl over 10 minutes followed by 500 ml intravenous 0.9% NaCl infusion over 8 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic AcidInvestigational product given within 2 hours of symptom onset | Drug | Tranexamic acid |
| Normal salineAlso: 0.9%NaClPlacebo given within 2 hours of symptom onset | Drug | Normal Saline (0.9% NaCl) |
Primary outcome
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
11 secondary outcomes
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
Absolute haematoma growth by 24±6 hours
Time frame: 24 hours ±6 hours
Relative haematoma growth by 24±6 hours
Time frame: 24 hour ±6 hours
Absolute intraventricular haematoma growth by 24 hours ±6 hours
Time frame: 24 hours ±6 hours
Absolute intracerebral plus intraventricular haematoma growth by 24±6 hours
Time frame: 24 hours ±6 hours
The number of patients with mRS 0-3 or back to pre-stroke level at 3 months
Time frame: 90 days ± 7 days
The number of patients with mRS 0-4 or back to pre-stroke level at 3 months
Time frame: 90 days ± 7 days
Categorical shift in mRS at 3 months
Time frame: 90 days ± 7 days
Major thromboembolic events (myocardial infarction, ischaemic stroke, or pulmonary embolism) within 3 months
Time frame: 3 months from baseline
Death within 3 months
Time frame: 3 months from baseline
Death within 7 days
Time frame: 7 days from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 38648814Yassi N, Zhao H, Churilov L, Wu TY, Ma H, Nguyen HT, Cheung A, Meretoja A, Mai DT, Kleinig T, Jeng JS, Choi PMC, Duc PD, Brown H, Ranta A, Spratt N, Cloud GC, Wang HK, Grimley R, Mahawish K, Cho DY, Shah D, Nguyen TMP, Sharma G, Yogendrakumar V, Yan B, Harrison EL, Devlin M, Cordato D, Martinez-Majander N, Strbian D, Thijs V, Sanders LM, Anderson D, Parsons MW, Campbell BCV, Donnan GA, Davis SM; STOP-MSU Trial Investigators. Tranexamic acid versus placebo in individuals with intracerebral haemorrhage treated within 2 h of symptom onset (STOP-MSU): an international, double-blind, randomised, phase 2 trial. Lancet Neurol. 2024 Jun;23(6):577-587. doi: 10.1016/S1474-4422(24)00128-5. Epub 2024 Apr 20.
- Derived from this study: PubMed 37870112Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey Donnan, MD principal investigator
The Florey Institute of Neuroscience and Mental Health
Stephen Davis, MD principal investigator
Melbourne Health Dept of Neurology & The University of Melbourne Dept of Medicine
Henry Zhao, MD principal investigator
Melbourne Health Dept of Neurology & The University of Melbourne Dept of Medicine
25 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic Acid and Normal saline in people with Intracerebral Haemorrhage, run by Neuroscience Trials Australia at 25 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Australia, New Zealand, Taiwan, Vietnam, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03385928, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.