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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03385928




Registration number
NCT03385928
Ethics application status
Date submitted
13/12/2017
Date registered
29/12/2017
Date last updated
28/09/2023

Titles & IDs
Public title
STOP-MSU: Stopping Haemorrhage With Tranexamic Acid for Hyperacute Onset Presentation Including Mobile Stroke Units
Scientific 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
Secondary ID [1] 0 0
NTA1702
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intracerebral Haemorrhage 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tranexamic Acid
Treatment: Drugs - Normal saline

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.

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.


Treatment: Drugs: Tranexamic Acid
Investigational product given within 2 hours of symptom onset

Treatment: Drugs: Normal saline
Placebo given within 2 hours of symptom onset
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Haematoma growth by 24±6 hours as defined by either =33%or =6ml increase from baseline ICH volume (mls)
Timepoint [1] 0 0
24 hours(plus or minus 6 hours)
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
24 hours ±6 hours
Secondary outcome [2] 0 0
Absolute haematoma growth by 24±6 hours
Timepoint [2] 0 0
24 hours ±6 hours
Secondary outcome [3] 0 0
Relative haematoma growth by 24±6 hours
Timepoint [3] 0 0
24 hour ±6 hours
Secondary outcome [4] 0 0
Absolute intraventricular haematoma growth by 24 hours ±6 hours
Timepoint [4] 0 0
24 hours ±6 hours
Secondary outcome [5] 0 0
Absolute intracerebral plus intraventricular haematoma growth by 24±6 hours
Timepoint [5] 0 0
24 hours ±6 hours
Secondary outcome [6] 0 0
The number of patients with mRS 0-3 or back to pre-stroke level at 3 months
Timepoint [6] 0 0
90 days ± 7 days
Secondary outcome [7] 0 0
The number of patients with mRS 0-4 or back to pre-stroke level at 3 months
Timepoint [7] 0 0
90 days ± 7 days
Secondary outcome [8] 0 0
Categorical shift in mRS at 3 months
Timepoint [8] 0 0
90 days ± 7 days
Secondary outcome [9] 0 0
Major thromboembolic events (myocardial infarction, ischaemic stroke, or pulmonary embolism) within 3 months
Timepoint [9] 0 0
3 months from baseline
Secondary outcome [10] 0 0
Death within 3 months
Timepoint [10] 0 0
3 months from baseline
Secondary outcome [11] 0 0
Death within 7 days
Timepoint [11] 0 0
7 days from baseline

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/05/2023
Sample size
Target
Accrual to date
Final
201
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [4] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [5] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [9] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [10] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [11] 0 0
University Hospital Geelong - Geelong
Recruitment hospital [12] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [13] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [14] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [15] 0 0
Mobile Stroke Unit - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 0 0
4575 - Birtinya
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3065 - Fitzroy
Recruitment postcode(s) [11] 0 0
3220 - Geelong
Recruitment postcode(s) [12] 0 0
3084 - Heidelberg
Recruitment postcode(s) [13] 0 0
3004 - Melbourne
Recruitment postcode(s) [14] 0 0
- Melbourne
Recruitment postcode(s) [15] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
Finland
State/province [1] 0 0
Helsinki
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Palmerston North
Country [4] 0 0
New Zealand
State/province [4] 0 0
Wellington
Country [5] 0 0
Taiwan
State/province [5] 0 0
Yanchao District
Country [6] 0 0
Taiwan
State/province [6] 0 0
Taichung City
Country [7] 0 0
Taiwan
State/province [7] 0 0
Taipei City
Country [8] 0 0
Vietnam
State/province [8] 0 0
Hanoi
Country [9] 0 0
Vietnam
State/province [9] 0 0
Ho Chi Minh City

Funding & Sponsors
Primary sponsor type
Other
Name
Neuroscience Trials Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Florey Institute of Neuroscience and Mental Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03385928
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Geoffrey Donnan, MD
Address 0 0
The Florey Institute of Neuroscience and Mental Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03385928