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    Clinical Trial Results:
    Effects of Hyperoxia on Haemostasis, Inflammation and oxidative Stress

    Summary
    EudraCT number
    2015-003962-10
    Trial protocol
    AT  
    Global end of trial date
    31 Dec 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    12 Jul 2020
    First version publication date
    12 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DOA_HO
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Department of Anaesthesia, Medical University of Vienna, 0043 14040041440, gisela.scharbert@meduniwien.ac.at
    Scientific contact
    Department of Anaesthesia, Medical University of Vienna, 0043 14040041440, gisela.scharbert@meduniwien.ac.at
    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
    13 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Hyperoxia induces ROS in leucocytes
    Protection of trial subjects
    Stress monitoring (ECG, bloodpressure) during inhalation
    Background therapy
    none
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Apr 2016
    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
    Austria: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    For recruitment information sheets were placed at the Medical University of Vienna

    Pre-assignment
    Screening details
    Peripheral venipuncture was performed to determine blood count and confirm the absences of liver diseases, kidney diseases, and coagulation disorders.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Intervention A
    Arm description
    Inhalation 100% Oxygen for 20 minutes 3 weeks wash out period Inhalation 21% Oxygen for 20 minutes
    Arm type
    Cross-Over Intervention A

    Investigational medicinal product name
    Oxygen MedicAL 100% (V/V)
    Investigational medicinal product code
    6948638.00.00
    Other name
    Pharmaceutical forms
    Medicinal gas, compressed
    Routes of administration
    Inhalation use
    Dosage and administration details
    20 minutes inhalation of 100% medical oxygen

    Investigational medicinal product name
    Air synthetical medical AIR LIQUIDE
    Investigational medicinal product code
    PL1
    Other name
    Pharmaceutical forms
    Medicinal gas, compressed
    Routes of administration
    Inhalation use
    Dosage and administration details
    20 minutes inhalation of Air synthetical medical gas: Oxygen 21-22,5% O2 Nitrogen 77,5-79,0% N2

    Arm title
    Intervention B
    Arm description
    Inhalation 21% Oxygen for 20 minutes 3 weeks wash out period Inhalation 100% Oxygen for 20 minutes
    Arm type
    Cross-Over Intervention B

    Investigational medicinal product name
    Oxygen MedicAL 100% (V/V)
    Investigational medicinal product code
    6948638.00.00
    Other name
    Pharmaceutical forms
    Medicinal gas, compressed
    Routes of administration
    Inhalation use
    Dosage and administration details
    20 minutes inhalation of 100% medical oxygen

    Investigational medicinal product name
    Air synthetical medical AIR LIQUIDE
    Investigational medicinal product code
    PL1
    Other name
    Pharmaceutical forms
    Medicinal gas, compressed
    Routes of administration
    Inhalation use
    Dosage and administration details
    20 minutes inhalation of Air synthetical medical gas: Oxygen 21-22,5% O2 Nitrogen 77,5-79,0% N2

    Number of subjects in period 1
    Intervention A Intervention B
    Started
    15
    15
    Completed
    15
    15

    Baseline characteristics

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

    Reporting group values
    Inhalation Total
    Number of subjects
    30 30
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    30 30
    Gender categorical
    Units: Subjects
        Male
    30 30

    End points

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    End points reporting groups
    Reporting group title
    Intervention A
    Reporting group description
    Inhalation 100% Oxygen for 20 minutes 3 weeks wash out period Inhalation 21% Oxygen for 20 minutes

    Reporting group title
    Intervention B
    Reporting group description
    Inhalation 21% Oxygen for 20 minutes 3 weeks wash out period Inhalation 100% Oxygen for 20 minutes

    Primary: ROS in leukocytes

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    End point title
    ROS in leukocytes
    End point description
    End point type
    Primary
    End point timeframe
    3h
    End point values
    Intervention A Intervention B
    Number of subjects analysed
    15
    15
    Units: Mean Fluorescence Intensity
        arithmetic mean (standard deviation)
    10999 ± 8765
    6371 ± 2114
    Statistical analysis title
    Primary Endpoint
    Comparison groups
    Intervention A v Intervention B
    Number of subjects included in analysis
    30
    Analysis specification
    Post-hoc
    Analysis type
    other [1]
    P-value
    ≤ 0.025
    Method
    ANOVA
    Confidence interval
    Notes
    [1] - cross-over ANOVA model with random patient factor and adjusting for period and baseline value

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Continuously during study
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23
    Frequency threshold for reporting non-serious adverse events: 0%
    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 are recorded

    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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