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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/NCT01702636




Registration number
NCT01702636
Ethics application status
Date submitted
3/10/2012
Date registered
8/10/2012
Date last updated
26/02/2020

Titles & IDs
Public title
STOP-AUST: The Spot Sign and Tranexamic Acid On Preventing ICH Growth - AUStralasia Trial
Scientific title
STOP-AUST: The Spot Sign and Tranexamic Acid On Preventing ICH Growth - AUStralasia Trial.
Secondary ID [1] 0 0
NTA1201
Universal Trial Number (UTN)
Trial acronym
STOP-AUST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intracerebral Haemorrhage 0 0
Stroke 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 - Placebo

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: Placebo - Intravenous placebo in 100 mL 0.9% NaCl over 10 minutes followed by 500 mL 0.9% NaCl infusion over 8 hours.


Treatment: Drugs: Tranexamic Acid


Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
ICH growth by 24±3 hours as defined by either 33% or 6 ml increase from baseline, adjusted for baseline ICH volume.
Timepoint [1] 0 0
24+/-3 hours
Secondary outcome [1] 0 0
Major thromboembolic events (myocardial infarction, ischaemic stroke, pulmonary embolism)
Timepoint [1] 0 0
Within 90+/-7 days
Secondary outcome [2] 0 0
Absolute ICH growth volume by 24±3 hours, adjusted for baseline ICH volume
Timepoint [2] 0 0
24+/-3 hours
Secondary outcome [3] 0 0
Absolute intraventricular haematoma (IVH) growth volume by 24±3 hours, adjusted for baseline IVH volume
Timepoint [3] 0 0
24+/-3 hours
Secondary outcome [4] 0 0
modified Rankin Scale (mRS) score of 0-4 at 3 months
Timepoint [4] 0 0
90+/-7 days
Secondary outcome [5] 0 0
modified Rankin Scale (mRS) score of 0-3 at 3 months
Timepoint [5] 0 0
90+/-7 days
Secondary outcome [6] 0 0
Categorical shift in mRS at 3 months, subject to the validity of proportional odds assumption
Timepoint [6] 0 0
90+/-7 days
Secondary outcome [7] 0 0
Death due to any cause by 3 months
Timepoint [7] 0 0
within 90+/-7 days

Eligibility
Key inclusion criteria
- Patients presenting with an acute ICH

- Contrast extravasation within the haemorrhage, "spot sign", evaluated from the CTA
according to three criteria, all of which must be present:

1. Serpiginous or spot-like appearance within the margin of a parenchymal haematoma
without connection to an outside vessel;

2. The density (in Hounsfield units) should be greater than that of the background
haematoma (site investigators are not required to document the density); and

3. No hyperdensity at the corresponding location on non-contrast CT.

- Age =18 years

- Treatment can commence within 1 hour of initial CT and within 4.5 hours of symptom
onset (or in patients with unknown time of symptom onset, the time patient was last
known to be well)

- Informed consent has been received in accordance to local ethics committee
requirements
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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, tumor, or infection

- Contrast already administered within 24 hours prior to initial CT or contraindication
to imaging with CT contrast agents (e.g. known or suspected iodine allergy or
significant renal failure)

- 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 14 days, irrespective of laboratory values

- 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.

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
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2019
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Gosford Hospital - Kanwal
Recruitment hospital [2] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [3] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [4] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [8] 0 0
Western Hospital - Footscray
Recruitment hospital [9] 0 0
Frankston Hospital - Frankston
Recruitment hospital [10] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2259 - Kanwal
Recruitment postcode(s) [2] 0 0
2310 - Newcastle
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
2050 - Sydney
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3011 - Footscray
Recruitment postcode(s) [9] 0 0
3199 - Frankston
Recruitment postcode(s) [10] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Finland
State/province [1] 0 0
Helsinki

Funding & Sponsors
Primary sponsor type
Other
Name
Neuroscience Trials Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of the study is to test if intracerebral haemorrhage (ICH) patients who have contrast
extravasation on computed tomography angiography, the "spot sign", have lower rates of
haematoma growth when treated with tranexamic acid within 4.5 hours of stroke onset, compared
to placebo.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01702636
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Atte Meretoja, 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/NCT01702636