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    Clinical Trial Results:
    Neuroprotective goal directed hemodynamic optimization in post-cardiac arrest patients: a randomized controlled trial (the NEUROPROTECT post-CA trial)

    Summary
    EudraCT number
    		 2015-002151-10
    Trial protocol
    		 BE  
    Global end of trial date
    30 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Mar 2024
    First version publication date
    20 Mar 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NEUROPROTECTpost-CA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02541591
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospitals Leuven (UZ Leuven)
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Stefan Janssens, UZ Leuven, 32 16344246, stefan.janssens@uzleuven.be
    Scientific contact
    Stefan Janssens, UZ Leuven, 32 16344246, stefan.janssens@uzleuven.be
    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
    30 Jun 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial is to assess whether or not a new goal directed hemodynamic optimization strategy can reduce cerebral ischemia in post-cardiac arrest (CA) patients as quantified by the apparent diffusion coefficient (ADC) on diffusion weighted MRI (DW-MRI) to be performed at day 4-5 post-CA using ADC scores in 11 pre-specified brain regions (frontal cortex, parietal cortex, temporal cortex, occipital cortex, precentral cortex, postcentral cortex, caudate nucleus, putamen, thalamus, cerebellum, pons)
    Protection of trial subjects
    see protocol
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2015
    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
    Belgium: 112
    Worldwide total number of subjects
    112
    EEA total number of subjects
    112
    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)
    56
    From 65 to 84 years
    56
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 o Out-of-hospital CA of presumed cardiac cause irrespective of the presenting rhythm o Unconsciousness (Glasgow coma scale < 8) at hospital admission o Age ≥ 18 years o Sustained return of spontaneous circulation (ROSC) (=when chest compressions have not been required for 20 consecutive minutes)

    Pre-assignment
    Screening details
    		 o Out-of-hospital CA of presumed cardiac cause irrespective of the presenting rhythm o Unconsciousness (Glasgow coma scale < 8) at hospital admission o Age ≥ 18 years o Sustained return of spontaneous circulation (ROSC) (=when chest compressions have not been required for 20 consecutive minutes)

    Period 1
    Period 1 title
    Overall trial (Baseline - day 4-5) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Neuroprotect
    Arm description
    		 MAP between 85-100mmHg SVO2 between 65-75%
    Arm type
    		 neuroprotect

    Investigational medicinal product name
    inotropes and vasopressors (dobutamine and levophed)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    see protocol

    Arm title
    		 Control
    Arm description
    		 MAP>65mmHg
    Arm type
    		 control

    Investigational medicinal product name
    inotropics and vasopression (dobutamine and levophed)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    see protocol

    Number of subjects in period 1 [1]
    		Neuroprotect Control
    Started
    52
    55
    Completed
    52
    55
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 4 patients were excluded in the FAS in the neuroprotect group (2 next of kin refused informed consent, and 2 asphyxia as cause of CA) 1 patient was excluded in the FAS in the placebo group (asphyxia as cause of CA)

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Neuroprotect
    Reporting group description
    		 MAP between 85-100mmHg SVO2 between 65-75%

    Reporting group title
    Control
    Reporting group description
    		 MAP>65mmHg

    Reporting group values
    		 Neuroprotect Control Total
    Number of subjects
    		 52 55 107
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 26 27 53
        From 65-84 years
    		 26 28 54
        85 years and over
    		 0 0 0
    Age continuous
    Age continuous
    Units: years
        median (standard deviation)
    		 64 ± 12 65 ± 13 -
    Gender categorical
    gender
    Units: Subjects
        Female
    		 13 13 26
        Male
    		 39 42 81
    Subject analysis sets

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    full analysis

    Subject analysis sets values
    		 Full analysis
    Number of subjects
    107
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    53
        From 65-84 years
    54
        85 years and over
    0
    Age continuous
    Age continuous
    Units: years
        median (standard deviation)
    65 ± 12
    Gender categorical
    gender
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Neuroprotect
    Reporting group description
    		 MAP between 85-100mmHg SVO2 between 65-75%

    Reporting group title
    Control
    Reporting group description
    		 MAP>65mmHg

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    full analysis

    Primary: % of Ischaemic Voxels With an ADC<0.65 mm2/s on Day 4-5 (Diffusion Weighted MRI)

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    End point title
    		 % of Ischaemic Voxels With an ADC<0.65 mm2/s on Day 4-5 (Diffusion Weighted MRI)
    End point description
    End point type
    Primary
    End point timeframe
    Day 4-5
    End point values
    		 Neuroprotect Control
    Number of subjects analysed
    52
    55
    Units: %
        number (not applicable)
    52
    55
    Statistical analysis title
    		 MI size / LV mass (%)
    Comparison groups
    Control v Neuroprotect
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0881 [1]
    Method
    		 ANOVA
    Parameter type
    		 Median difference (final values)
    Point estimate
    1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.98
    Notes
    [1] - due to non normality of the residuals the data were log-transformed prior to the anova

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During study drug treatment (36 hours)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Neuroprotect
    Reporting group description
    		 MAP between 85-100mmHg SVO2 between 65-75%

    Reporting group title
    Control
    Reporting group description
    		 MAP>65mmHg

    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: no non serious adverse events were reported
    Serious adverse events
    		 Neuroprotect Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 52 (13.46%)
    21 / 52 (40.38%)
         number of deaths (all causes)
    31
    29
         number of deaths resulting from adverse events
    Vascular disorders
    limb ischemia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    7 / 52 (13.46%)
    13 / 52 (25.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 13
         deaths causally related to treatment / all
    0 / 4
    0 / 6
    Atrial fibrillation
         subjects affected / exposed
    0 / 52 (0.00%)
    4 / 52 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Pulmonary congestion
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 52 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    General disorders and administration site conditions
    death
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Neuroprotect Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 52 (0.00%)

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30895296
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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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