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    Clinical Trial Results:
    Behandling ved intraventrikulær blødning: Et pilotstudie af virkningen med tidlig intraventrikulær actilysebehandling.

    Summary
    EudraCT number
    		 2008-008215-25
    Trial protocol
    		 DK  
    Global end of trial date
    08 Aug 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Oct 2017
    First version publication date
    25 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    H-A-2008-109
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Walter Fischer
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark,
    Public contact
    Walter Fischer, Walter Fischer, w.fischer@telia.com
    Scientific contact
    Walter Fischer, Walter Fischer, 0045 35458230 , walter.fischer@regionh.dk
    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
    08 Aug 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Aug 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Aug 2011
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of the present trial is to show that Actilyse removes blood from the ventricles of the brain, more efficiently than NaCl.
    Protection of trial subjects
    Patients with ongoing anticoagulant treatment presenting with an intracerebroventricular blood clot had their coagulation status normalised prior to Actilyse treatment of the blood clot in the brain.
    Background therapy
    		 None
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Aug 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    4
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Date:2010-02-12 Period:2010-02-12 - 2011-08-11 Region:Copenhagen, Denmark

    Pre-assignment
    Screening details
    		 Screened subjects:12 Included subjects:12

    Pre-assignment period milestones
    Number of subjects started
    		 12
    Number of subjects completed
    		 12

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Actilyse
    Arm description
    		 Treatment with Actilyse, which brakes down the blood clot in the brain
    Arm type
    		 Experimental

    Investigational medicinal product name
    Actilyse
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intracerebroventricular use
    Dosage and administration details
    4 mg (1 mg/ml) = 4 ml intracerebroventricularly

    Arm title
    		 Control
    Arm description
    		 4 ml of NaCl 0.9%
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sodium Chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intracerebroventricular use
    Dosage and administration details
    4 ml NaCl was infused intracerebroventricularly

    Number of subjects in period 1
    		Actilyse Control
    Started
    8
    4
    Completed
    8
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Subjects 18-84 years of age with intracerebroventricular blood clots in the brain.

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 12 12
    Age categorical
    Patients enrolled were over 18 years of age
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 4 4
        From 65-84 years
    		 8 8
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 5 5
    Subject analysis sets

    Subject analysis set title
    Actilyse
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Experimental group

    Subject analysis set title
    Control
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    NaCl

    Subject analysis sets values
    		 Actilyse Control
    Number of subjects
    8
    4
    Age categorical
    Patients enrolled were over 18 years of age
    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)
    3
    1
        From 65-84 years
    5
    3
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Actilyse
    Reporting group description
    		 Treatment with Actilyse, which brakes down the blood clot in the brain

    Reporting group title
    Control
    Reporting group description
    		 4 ml of NaCl 0.9%

    Subject analysis set title
    Actilyse
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Experimental group

    Subject analysis set title
    Control
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    NaCl

    Primary: LeRoux Blood clot volume score

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    End point title
    		 LeRoux Blood clot volume score [1]
    End point description
    The blood volume of the ventricles are scored accordingly: 4 = completely filled with blood 3 = more than half filled with blood 2 = less than half filled with blood 1 = traces of blood
    End point type
    Primary
    End point timeframe
    2010-1011
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The trial had to be terminated due to the fact that a monitoring committee had not been assigned. By then too few individuals had been included in the trial in order to perform any meaningful statistical analysis.
    End point values
    		 Actilyse Control
    Number of subjects analysed
    8
    4
    Units: 1
        number (not applicable)
    25
    39
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    2010-2011
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 1%
    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: There was one non-serious adverse event (CSF infection) but I cannot open the "box" for this category in the present data form: Non-serious adverse events (lacks a +) No non-serious adverse events have been specified.

    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 reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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