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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03385928
Ethics application status
Date submitted
13/12/2017
Date registered
29/12/2017
Date last updated
5/12/2019

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 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 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
Relative ICH haematoma growth at 24±3 hours, adjusted for baseline ICH volume (mls) - Relative ICH haematoma growth
Timepoint [1] 0 0
24 hours(plus or minus 3 hours)
Secondary outcome [1] 0 0
ICH growth - ICH growth as defined by either 33% or 6ml increase from baseline, adjusted for baseline ICH volume
Timepoint [1] 0 0
24 hours (plus or minus 3 hours)
Secondary outcome [2] 0 0
Absolute ICH growth (mls) - Absolute ICH growth
Timepoint [2] 0 0
24 hours (plus or minus 3 hours)
Secondary outcome [3] 0 0
Relative ICH growth volume (mls) - Relative and absolute ICH growth volume, adjusted for baseline ICH volume
Timepoint [3] 0 0
1 hour after baseline CT
Secondary outcome [4] 0 0
Major thromboembolic events - Major thromboembolic events (myocardial infarction, ischaemic stroke, pulmonary embolism) or death
Timepoint [4] 0 0
3 months
Secondary outcome [5] 0 0
Intraventricular haematoma growth - Absolute intraventricular haematoma (IVH) growth volume adjusted for baseline IVH volume
Timepoint [5] 0 0
24 hours (plus or minus 3 hours)
Secondary outcome [6] 0 0
Modified Rankin Scale (mRS) - 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)
Timepoint [6] 0 0
3 months
Secondary outcome [7] 0 0
Modified Rankin Scale (mRS) - Categorical shift in mRS (0-6 with 6 being worst outcome)
Timepoint [7] 0 0
3 months

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
Gender
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 14 days, irrespective of laboratory values

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Wellington

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 will be 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 ICH (intracranial haemorrhage) patients treated with
intravenous tranexamic acid within 2 hours of symptom onset will have lower rates of
haematoma growth than compared to placebo.
Trial website
https://clinicaltrials.gov/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
Henry Zhao, MD
Address 0 0
Country 0 0
Phone 0 0
+61 3 9342 7000
Fax 0 0
Email 0 0
henry.zhao@mh.org.au
Contact person for scientific queries

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