Clinical Trial Results:
STOP-MSU – Stopping haemorrhage with Tranexamic acid for hyperacute Onset Presentation including Mobile Stroke Units
Summary
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EudraCT number |
2020-004746-10 |
Trial protocol |
FI |
Global end of trial date |
28 May 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
18 May 2024
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First version publication date |
18 May 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
NTA1702
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03385928 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
The Florey Institute of Neuroscience and Mental Health
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Sponsor organisation address |
245 Burgundy Street, Heidelberg, Australia, VIC 3084
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Public contact |
Michele Sallaberger, The Florey Institute of Neuroscience and Mental Health, 61 390357269, michele.sallaberger@florey.edu.au
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Scientific contact |
Michele Sallaberger, The Florey Institute of Neuroscience and Mental Health, 61 390357269, michele.sallaberger@florey.edu.au
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
19 Apr 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 May 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
28 May 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To determine the efficacy and safety of administration of intravenous
tranexamic acid in patients with intracerebral haemorrhage within 2
hours of onset.
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Protection of trial subjects |
Informed consent
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jul 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Finland: 18
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Country: Number of subjects enrolled |
Australia: 145
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Country: Number of subjects enrolled |
Taiwan: 38
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Worldwide total number of subjects |
201
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EEA total number of subjects |
18
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
201
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
Pre-assignment
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Screening details |
- | |||||||||
Pre-assignment period milestones
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Number of subjects started |
202 [1] | |||||||||
Number of subjects completed |
201 | |||||||||
Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Consent withdrawn by subject: 1 | |||||||||
Notes [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: 1 patient withdrew consent |
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Period 1
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Period 1 title |
Baseline
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Carer, Assessor | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Tranexamic acid | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
tranexamic acid
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Investigational medicinal product code |
ATC B02AA02
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Intravenous infusion of 1 g over 10 min followed by 1 g over 8 h
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Arm title
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Placebo | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
normal saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Intravenous infusion of 1 g over 10 min followed by 1 g over 8 h
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Period 2
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Period 2 title |
24 hour
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Carer, Assessor | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Tranexamic acid | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
tranexamic acid
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Investigational medicinal product code |
ATC B02AA02
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Intravenous infusion of 1 g over 10 min followed by 1 g over 8 h
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Arm title
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Placebo | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Normal saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Intravenous 1 g over 10 min followed by 1 g over 8 h
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Period 3
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Period 3 title |
90 days
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Assessor, Monitor, Carer | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Tranexamic acid | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
tranexamic acid
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Investigational medicinal product code |
ATC B02AA02
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Intravenous infusion of 1 g over 10 min followed by 1 g over 8 h
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Arm title
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Placebo | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
normal saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Intravenous infusion of 1 g over 10 min followed by 1 g over 8 h
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Baseline characteristics reporting groups
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Reporting group title |
Tranexamic acid
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Tranexamic acid
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Reporting group description |
- | ||
Reporting group title |
Placebo
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Reporting group description |
- | ||
Reporting group title |
Tranexamic acid
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Reporting group description |
- | ||
Reporting group title |
Placebo
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Reporting group description |
- | ||
Reporting group title |
Tranexamic acid
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Reporting group description |
- | ||
Reporting group title |
Placebo
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Reporting group description |
- |
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End point title |
Haematoma growth | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
24 hours
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Statistical analysis title |
Primary outcome | |||||||||
Comparison groups |
Tranexamic acid v Placebo
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Number of subjects included in analysis |
201
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.37 | |||||||||
Method |
Regression, Logistic | |||||||||
Parameter type |
Risk difference (RD) | |||||||||
Point estimate |
0.06
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
-0.07 | |||||||||
upper limit |
0.19 |
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Adverse events information [1]
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Timeframe for reporting adverse events |
90 days
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
NA | ||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
Tranexamic acid
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: NA |
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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15 Oct 2020 |
Version 6.0, 15 October 2020 |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/38648814 |