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    Clinical Trial Results:
    A randomised controlled trial of topical intranasal tranexamic acid versus placebo to reduce the need for nasal packing in patients presenting to the Emergency Department with spontaneous epistaxis.

    Summary
    EudraCT number
    		 2016-001530-10
    Trial protocol
    		 GB  
    Global end of trial date
    22 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Aug 2020
    First version publication date
    02 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NoPac01
    Additional study identifiers
    ISRCTN number
    		 ISRCTN34153772
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IRAS: 197027, EudraCT: 2016-001530-10
    Sponsors
    Sponsor organisation name
    Royal Devon & Exeter NHS Foundation Trust
    Sponsor organisation address
    Bowmoor House, Wonford Road, Exeter, United Kingdom, EX2 5DW
    Public contact
    Clinical Trial Manager, Peninsula Clinical Trials Unit, 44 (0)1752 315252, nopac@plymouth.ac.uk
    Scientific contact
    Clinical Trial Manager, Peninsula Clinical Trials Unit, 44 (0)1752 315252, nopac@plymouth.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Jul 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Jul 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the study is to test the effectiveness of topical intranasal tranexamic acid (TXA) in reducing the need for anterior nasal packing in adult patients presenting to the Emergency Department (ED) with spontaneous. The objectives are to compare the effect of topical TXA versus placebo on the need for nasal packing; need for hospital admission; subsequent length of hospital stay; requirement for blood products; re-bleeding rate for patients subsequently discharged from the ED; adverse events, including thrombotic complications. In lay language, the research question is: For patients attending the Emergency Department (Accident and Emergency) with a serious nosebleed, can tranexamic acid applied inside the bleeding nostril reduce the need for nasal packing (a large dressing filling the nostril)?
    Protection of trial subjects
    Specific measures that were put in place to protect trial subjects, for example measures to minimise pain and distress, were: 1) An epistaxis nasal clip was provided for each participant. The use of the nasal clip allowed patients to read the study information and take part in the consent process unimpeded by having to hold their nose during this time. 2) In the event that the patient was willing to participate in the study but was unable to sign and/or date the consent form because of practical difficulties (e.g. unable easily to hold a pen due to contamination of hands with blood), a witness may sign and/or date the consent form on the patient’s behalf.
    Background therapy
    		 Treatments that were not test or comparator products that were used across all arms/groups in this trial were: During the index ED attendance: Standardised vasoconstrictor therapy (not formally part of the study i.e. not part of the research process requiring participant consent):Phenylephedrine and lignocaine; adrenaline and lignocaine; adrenaline; cocaine HCL/Spray; lignocaine. During the index ED attendance and/or during the follow-up period: Nasal cautery; intranasal vasoconstrictor; TXA; resorbable nasal pack; Vitamin K; nasal ligation; blood transfusion (the majority of participants who required a blood transfusion were given packed red cells).
    Evidence for comparator
    		 The rationale for the comparator used in this trial, i.e. water for injection (for topical use), is that the excipient for the active IMP is water for injection. On inspection, the comparator is indistinguishable to the active IMP by sight, taste or smell.
    Actual start date of recruitment
    05 May 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 496
    Worldwide total number of subjects
    496
    EEA total number of subjects
    496
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    136
    From 65 to 84 years
    274
    85 years and over
    86

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 496 participants were recruited to this trial, from 5 May 2017 to 31 March 2019, from 25 NHS hospitals in the UK (24 hospitals in England; 1 in Scotland).

    Pre-assignment
    Screening details
    		 Inclusion criteria: aged 18 or over; present to the ED with spontaneous, atraumatic epistaxis, unresolved with simple first aid and standard initial therapy. Exclusion criteria apply.

    Pre-assignment period milestones
    Number of subjects started
    		 496
    Number of subjects completed
    		 496

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Water for injections
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Impregnated plug
    Routes of administration
    Intranasal use
    Dosage and administration details
    Up to two doses of placebo may be given, each dose being approximately 2mL of water for injections. One dental roll (supplied) will be inserted into the vial of trial solution and soaked in the allocated trial solution until saturated. This will leave approximately half of the 4mL trial solution in the vial. The soaked dental roll will be inserted into the bleeding nostril and gentle pressure applied with an epistaxis nasal clip for at least ten minutes. If the epistaxis persists (as defined by the presence of fresh blood on the upper lip or philtrum after wiping), a second dental roll should be soaked in the remaining trial solution until saturated or no solution remains. The saturated roll will be inserted into the affected nostril, with gentle pressure applied for at least a further ten minutes.

    Arm title
    		 Active
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tranexamic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Impregnated plug
    Routes of administration
    Intranasal use
    Dosage and administration details
    Up to two doses of active IMP may be given, each dose being approximately 2mL of 100mg/mL TXA in water for injection. One dental roll (supplied) will be inserted into the vial of trial solution and soaked in the allocated trial solution until saturated. This will leave approximately half of the 4mL trial solution in the vial. The soaked dental roll will be inserted into the bleeding nostril and gentle pressure applied with an epistaxis nasal clip for at least ten minutes. If the epistaxis persists (as defined by the presence of fresh blood on the upper lip or philtrum after wiping), a second dental roll should be soaked in the remaining trial solution until saturated or no solution remains. The saturated roll will be inserted into the affected nostril, with gentle pressure applied for at least a further ten minutes.

    Number of subjects in period 1
    		Control Active
    Started
    242
    254
    Completed
    242
    254
    Period 2
    Period 2 title
    Overall Trial
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Water for injections
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Impregnated plug
    Routes of administration
    Intranasal use
    Dosage and administration details
    Up to two doses of placebo may be given, each dose being approximately 2mL of water for injections. One dental roll (supplied) will be inserted into the vial of trial solution and soaked in the allocated trial solution until saturated. This will leave approximately half of the 4mL trial solution in the vial. The soaked dental roll will be inserted into the bleeding nostril and gentle pressure applied with an epistaxis nasal clip for at least ten minutes. If the epistaxis persists (as defined by the presence of fresh blood on the upper lip or philtrum after wiping), a second dental roll should be soaked in the remaining trial solution until saturated or no solution remains. The saturated roll will be inserted into the affected nostril, with gentle pressure applied for at least a further ten minutes.

    Arm title
    		 Active
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tranexamic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Impregnated plug
    Routes of administration
    Intranasal use
    Dosage and administration details
    Up to two doses of active IMP may be given, each dose being approximately 2mL of 100mg/mL TXA in water for injections. One dental roll (supplied) will be inserted into the vial of trial solution and soaked in the allocated trial solution until saturated. This will leave approximately half of the 4mL trial solution in the vial. The soaked dental roll will be inserted into the bleeding nostril and gentle pressure applied with an epistaxis nasal clip for at least ten minutes. If the epistaxis persists (as defined by the presence of fresh blood on the upper lip or philtrum after wiping), a second dental roll should be soaked in the remaining trial solution until saturated or no solution remains. The saturated roll will be inserted into the affected nostril, with gentle pressure applied for at least a further ten minutes.

    Number of subjects in period 2
    		Control Active
    Started
    242
    254
    Completed
    242
    254

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control
    Reporting group description
    		 -

    Reporting group title
    Active
    Reporting group description
    		 -

    Reporting group values
    		 Control Active Total
    Number of subjects
    		 242 254 496
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 72.3 ± 13.9 70.1 ± 15.6 -
    Gender categorical
    Units: Subjects
        Female
    		 100 126 226
        Male
    		 142 128 270
    Anticoagulant medication
    Units: Subjects
        No
    		 76 99 175
        Yes
    		 166 155 321
    Hypertension
    Units: Subjects
        No
    		 93 101 194
        Yes
    		 149 153 302
    Ischemic heart disease
    Units: Subjects
        No
    		 183 205 388
        Yes
    		 59 49 108
    Diabetes
    Units: Subjects
        No
    		 204 221 425
        Yes
    		 38 33 71
    Thromboembolic disease
    Units: Subjects
        No
    		 226 228 454
        Yes
    		 16 26 42
    Alcoholic liver disease
    Units: Subjects
        No
    		 241 252 493
        Yes
    		 1 2 3
    Any bleeding disorder
    Units: Subjects
        No
    		 234 249 483
        Yes
    		 8 5 13
    Systolic blood pressure
    Units: mm/Hg
        arithmetic mean (standard deviation)
    		 150.7 ± 25.8 150.2 ± 27.9 -
    Diastolic blood pressure
    Units: mm/Hg
        arithmetic mean (standard deviation)
    		 87.0 ± 15.3 85.8 ± 18.4 -
    Pulse
    Units: bpm
        arithmetic mean (standard deviation)
    		 82.2 ± 16.6 82.6 ± 17.2 -

    End points

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    End points reporting groups
    Reporting group title
    Control
    Reporting group description
    		 -

    Reporting group title
    Active
    Reporting group description
    		 -
    Reporting group title
    Control
    Reporting group description
    		 -

    Reporting group title
    Active
    Reporting group description
    		 -

    Subject analysis set title
    Placebo Treatment Compliant
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Placebo treatment group excluding any participant who did not complete the first dose or second dose (if indicated).

    Subject analysis set title
    TXA Treatment Compliant
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants allocated to TXA excluding any participant who did not complete the first dose or second dose (if indicated).

    Subject analysis set title
    Placebo Protocol Compliant
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants allocated to placebo excluding any participant who did receive vasoconstrictor therapy prior to the trial intervention and/or did not complete the first dose or second dose (if indicated).

    Subject analysis set title
    TXA Protocol Compliant
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants allocated to TXA excluding any participant who did receive vasoconstrictor therapy prior to the trial intervention and/or did not complete the first dose or second dose (if indicated).

    Subject analysis set title
    Placebo Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants allocated to placebo in the safety population. The safety population is those in the ITT population who have at least one (of the possible two) dental rolls soaked in the allocated solution, fully inserted into their nose (even if removed before the intended 10 minutes).

    Subject analysis set title
    TXA Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants allocated to TXA in the safety population. The safety population is those in the ITT population who have at least one (of the possible two) dental rolls soaked in the allocated solution, fully inserted into their nose (even if removed before the intended 10 minutes).

    Subject analysis set title
    Placebo - anticoagulant
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    subjects in the placebo group on anticoagulant medication

    Subject analysis set title
    TXA - anticoagulant
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants allocated to TXA on anticoagulant medication

    Subject analysis set title
    Placebo - no anticoagulant
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants allocated to placebo not on anticoagulant medication

    Subject analysis set title
    TXA - no anticoagulant
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants allocated to TXA not taking anticoagulant medication

    Primary: Proportion of subjects with anterior nasal packing in index ED visit

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    End point title
    		 Proportion of subjects with anterior nasal packing in index ED visit
    End point description
    End point type
    Primary
    End point timeframe
    Index ED
    End point values
    		 Control Active Placebo Treatment Compliant TXA Treatment Compliant Placebo Protocol Compliant TXA Protocol Compliant Placebo - anticoagulant TXA - anticoagulant Placebo - no anticoagulant TXA - no anticoagulant
    Number of subjects analysed
    242
    254
    227
    246
    224
    242
    166
    155
    76
    99
    Units: 496
        No
    142
    143
    137
    141
    135
    136
    96
    83
    46
    60
        Yes
    100
    111
    90
    106
    89
    106
    70
    72
    30
    39
    Statistical analysis title
    		 Primary analysis
    Statistical analysis description
    Binomial logistic regression to compare allocated groups
    Comparison groups
    Active v Control
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.585
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.107
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.769
         upper limit
    		 1.594
    Notes
    [1] - Mixed effects logistic regression, adjusting for study center as a random effect and allocated group as a fixed effect.
    Statistical analysis title
    		 Sensitivity Analysis Treatment PP
    Statistical analysis description
    Logistic regression
    Comparison groups
    Placebo Treatment Compliant v TXA Treatment Compliant
    Number of subjects included in analysis
    473
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.346
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.822
         upper limit
    		 1.752
    Notes
    [2] - Mixed effects logistic regression, adjusting for study center as a random effect and allocated group as a fixed effect.
    Statistical analysis title
    		 Sensitivity Analysis Compliance PP
    Comparison groups
    Placebo Protocol Compliant v TXA Protocol Compliant
    Number of subjects included in analysis
    466
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.374
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.182
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.818
         upper limit
    		 1.71
    Notes
    [3] - Mixed effects logistic regression, adjusting for study center as a random effect and allocated group as a fixed effect.
    Statistical analysis title
    		 Sub-group analysis
    Statistical analysis description
    Sub-group analysis to see if there might be an interaction between allocated groups and anticoagulant medication.
    Comparison groups
    Placebo - no anticoagulant v TXA - no anticoagulant v TXA - anticoagulant v Placebo - anticoagulant
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.288
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.591
         upper limit
    		 2.809
    Notes
    [4] - mixed effects logistic regression model, adjusting for study center as a random effect. Interpretation focused on the interaction between anticoagulant medication and allocated group as a fixed effect. Interpretations were exploratory.

    Primary: Any Packing during index ED or after

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    End point title
    		 Any Packing during index ED or after
    End point description
    A slight modification to the definition of the primary outcome, need for packing during the indexed ED admission or after.
    End point type
    Primary
    End point timeframe
    Overall trial
    End point values
    		 Control Active
    Number of subjects analysed
    242
    254
    Units: 496
        No
    125
    120
        Yes
    117
    134
    Statistical analysis title
    		 Sensitivity Analysis
    Statistical analysis description
    Sensitivity analysis on a modification of the primary outcome
    Comparison groups
    Control v Active
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.312
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.204
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.752
    Notes
    [5] - Mixed effects logistic regression adjusting for study center as a random effect and allocated group as a fixed effect.

    Secondary: Any ED treatment

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    End point title
    		 Any ED treatment
    End point description
    any treatment for epistaxis during the indexed ED visit
    End point type
    Secondary
    End point timeframe
    Indexed ED
    End point values
    		 Control Active
    Number of subjects analysed
    242
    254
    Units: 496
        No
    95
    97
        Yes
    147
    157
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    Active v Control
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 = 0.807
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.046
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.729
         upper limit
    		 1.501
    Notes
    [6] - Mixed effects binomial logistic regression comparing allocated groups adjusting for study center as a random effect

    Secondary: Hospital admission

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    End point title
    		 Hospital admission
    End point description
    Hospital admission following ED visit
    End point type
    Secondary
    End point timeframe
    Overall
    End point values
    		 Control Active
    Number of subjects analysed
    242
    254
    Units: 496
        No
    132
    144
        Yes
    110
    110
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    Control v Active
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.63
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.917
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.643
         upper limit
    		 1.307
    Notes
    [7] - Mixed effects logistic regression, adjusting for study center as a random effect and allocated group as a fixed effect.

    Secondary: Length of hospital stay

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    End point title
    		 Length of hospital stay
    End point description
    End point type
    Secondary
    End point timeframe
    overall trial
    End point values
    		 Control Active
    Number of subjects analysed
    242
    254
    Units: 496
        median (inter-quartile range (Q1-Q3))
    2 (1 to 3)
    1.5 (1 to 2)
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    Control v Active
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 = 0.651
    Method
    		 Regression, negative binomial
    Parameter type
    		 between group difference
    Point estimate
    0.049
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.185
         upper limit
    		 0.282
    Notes
    [8] - Mixed effects, negative binomial, regression model

    Secondary: Blood transfusion

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    End point title
    		 Blood transfusion
    End point description
    End point type
    Secondary
    End point timeframe
    overall trial
    End point values
    		 Control Active
    Number of subjects analysed
    242
    254
    Units: 496
        No
    236
    247
        Yes
    6
    7
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    Control v Active
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.847
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.115
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.369
         upper limit
    		 3.365
    Notes
    [9] - Mixed effects logistic regression, adjusting for study center as a random effect and allocated group as a fixed effect.

    Secondary: Recurrent epistaxis

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    End point title
    		 Recurrent epistaxis
    End point description
    End point type
    Secondary
    End point timeframe
    overall trial
    End point values
    		 Control Active
    Number of subjects analysed
    242
    252 [10]
    Units: 494
        No
    203
    203
        Yes
    39
    49
    Notes
    [10] - Two participants were missing outcome data
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    Control v Active
    Number of subjects included in analysis
    494
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 = 0.335
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.257
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 2.002
    Notes
    [11] - Mixed effects logistic regression, adjusting for study center as a random effect and allocated group as a fixed effect.

    Secondary: Thrombotic evens

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    End point title
    		 Thrombotic evens
    End point description
    End point type
    Secondary
    End point timeframe
    overall trial
    End point values
    		 Control Active
    Number of subjects analysed
    242
    251 [12]
    Units: 493
        No
    241
    251
        Yes
    1
    0
    Notes
    [12] - Missing outcome data on three participants
    No statistical analyses for this end point

    Secondary: Any treatment for epistaxis

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    End point title
    		 Any treatment for epistaxis
    End point description
    Any treatment of epistaxis during index ED visit or 7 days post discharge
    End point type
    Secondary
    End point timeframe
    overall trial
    End point values
    		 Control Active
    Number of subjects analysed
    242
    254
    Units: 496
        No
    68
    70
        yes
    174
    184
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    Control v Active
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [13]
    P-value
    		 = 0.836
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.043
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.697
         upper limit
    		 1.561
    Notes
    [13] - Mixed effects logistic regression, adjusting for study center as a random effect and allocated group as a fixed effect.

    Secondary: Adverse reactions

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    End point title
    		 Adverse reactions
    End point description
    End point type
    Secondary
    End point timeframe
    Overall trial
    End point values
    		 Placebo Safety TXA Safety
    Number of subjects analysed
    241 [14]
    254
    Units: 495
        No
    238
    245
        Yes
    3
    9
    Notes
    [14] - 1 participant did not have any trial treatment
    Statistical analysis title
    		 Safety Analysis
    Comparison groups
    Placebo Safety v TXA Safety
    Number of subjects included in analysis
    495
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [15]
    P-value
    		 = 0.111
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.975
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.779
         upper limit
    		 11.353
    Notes
    [15] - Mixed effects logistic regression, adjusting for study center as a random effect and allocated group as a fixed effect.

    Secondary: Serious adverse events

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    End point title
    		 Serious adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    Overall trial
    End point values
    		 Placebo Safety TXA Safety
    Number of subjects analysed
    241 [16]
    254
    Units: 495
        No
    236
    244
        Yes
    5
    10
    Notes
    [16] - 1 participant did not begin trial treatment
    Statistical analysis title
    		 Safety Analysis
    Comparison groups
    Placebo Safety v TXA Safety
    Number of subjects included in analysis
    495
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [17]
    P-value
    		 = 0.235
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.935
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.651
         upper limit
    		 5.745
    Notes
    [17] - mixed effects logistic regression model, adjusting for study center as a random effect and allocated group as a fixed effect.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall trial
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 -

    Reporting group title
    Control
    Reporting group description
    		 -

    Serious adverse events
    		 Experimental Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 254 (4.33%)
    5 / 242 (2.07%)
         number of deaths (all causes)
    3
    2
         number of deaths resulting from adverse events
    3
    2
    Investigations
    Investigations
    Additional description: Investigations
         subjects affected / exposed
    1 / 254 (0.39%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Additional description: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
         subjects affected / exposed
    1 / 254 (0.39%)
    0 / 242 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Vascular disorders
    Additional description: Vascular disorders
         subjects affected / exposed
    1 / 254 (0.39%)
    0 / 242 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac disorders
    Additional description: Cardiac disorders
         subjects affected / exposed
    2 / 254 (0.79%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Nervous system disorders
    Nervous system disorders
    Additional description: Nervous system disorders
         subjects affected / exposed
    2 / 254 (0.79%)
    0 / 242 (0.00%)
         occurrences causally related to treatment / all
    3 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
    Additional description: Blood and lymphatic system disorders
         subjects affected / exposed
    1 / 254 (0.39%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal disorders
    Additional description: Gastrointestinal disorders
         subjects affected / exposed
    1 / 254 (0.39%)
    0 / 242 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
    Additional description: Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed
    2 / 254 (0.79%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infections and infestations
    Infections and infestations
    Additional description: Infections and infestations
         subjects affected / exposed
    2 / 254 (0.79%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Experimental Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 254 (2.76%)
    3 / 242 (1.24%)
    Nervous system disorders
    Nervous system disorders
    Additional description: Nervous system disorders
         subjects affected / exposed
    5 / 254 (1.97%)
    2 / 242 (0.83%)
         occurrences all number
    5
    2
    General disorders and administration site conditions
    General disorders and administration site conditions
    Additional description: General disorders and administration site conditions
         subjects affected / exposed
    2 / 254 (0.79%)
    1 / 242 (0.41%)
         occurrences all number
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None.
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