Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Influence of vasopressors on brain oxygenation and microcirculation in anesthetized patients with cerebral tumors

    Summary
    EudraCT number
    		 2015-001359-60
    Trial protocol
    		 DK  
    Global end of trial date
    29 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Dec 2021
    First version publication date
    17 Dec 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Vasobrain01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02713087
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Nørrebrogade 44, Aarhus C, Denmark, 8000
    Public contact
    Neuroanesthesia trial info/KK, Aarhus University Hospital, 45 78463333, klaukoch@rm.dk
    Scientific contact
    Neuroanesthesia trial info/KK, Aarhus University Hospital, 45 78463333, klaukoch@rm.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
    29 Nov 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate whether phenylephrine and ephedrine causes different alterations in microcirculation and oxygenation, as measured with magnetic resonance imaging (MRI) and positron emission tomography (PET), in anesthetized patients with brain tumors. Two RCT rapported and attached under "more information". Only one RCT will be rapported in this system, but all details could be found in the articles attached. Twenty-four patients were included in each study, but only one study (24 patients) will bed rapported in this system.
    Protection of trial subjects
    All patients were anesthetized during examination and we sought to minimize the extra time in general anesthesia. Patients were monitored according to hospital standards during anesthesia. No other measures were taken.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Aug 2015
    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: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    18
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Still only one study will be rapported in this system. The study enrolled patients in a period from september 2015 until november 2016 and included 24 patients - all recruited in the day care clinic, where they were examined before surgery.

    Pre-assignment
    Screening details
    		 Patients were screened according to in- and exclusion criteria rapported in the articles attached under "more information".

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Phenylephrine
    Arm description
    		 One vasopressor drug were given to half of the patients in the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Phenylephrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for dispersion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Phenylephrine 0,1 mg/ml given until MAP > 60 or a 20% increase from baseline and until final MRI examination.

    Arm title
    		 Ephedrine
    Arm description
    		 One vasopressor drug were given to half of the patients in the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ephedrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for dispersion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ephedrine 0,1 mg/ml given until MAP > 60 or a 20% increase from baseline and until final MRI examination.

    Number of subjects in period 1
    		Phenylephrine Ephedrine
    Started
    12
    12
    Completed
    10
    10
    Not completed
    2
    2
         Physician decision
    2
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Phenylephrine
    Reporting group description
    		 One vasopressor drug were given to half of the patients in the study.

    Reporting group title
    Ephedrine
    Reporting group description
    		 One vasopressor drug were given to half of the patients in the study.

    Reporting group values
    		 Phenylephrine Ephedrine Total
    Number of subjects
    		 12 12 24
    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)
    		 64 ± 8 56 ± 14 -
    Gender categorical
    Units: Subjects
        Female
    		 6 6 12
        Male
    		 6 6 12

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Phenylephrine
    Reporting group description
    		 One vasopressor drug were given to half of the patients in the study.

    Reporting group title
    Ephedrine
    Reporting group description
    		 One vasopressor drug were given to half of the patients in the study.

    Primary: Difference in capillary transit time heterogeneity in the contralateral hemisphere

    		 Close Top of page
    End point title
    		 Difference in capillary transit time heterogeneity in the contralateral hemisphere [1]
    End point description
    End point type
    Primary
    End point timeframe
    The endpoint is accesed during the MRI before surgery.
    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: All the statistical analysis can be seen in the articles attached.
    End point values
    		 Phenylephrine Ephedrine
    Number of subjects analysed
    10
    10
    Units: second
        arithmetic mean (standard deviation)
    0.2 ± 0.4
    -0.4 ± 0.3
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    From the time of anesthesia until end of surgery.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    1.0
    Reporting groups
    Reporting group title
    Phenylephrine
    Reporting group description
    		 One vasopressor drug were given to half of the patients in the study.

    Reporting group title
    Ephedrine
    Reporting group description
    		 One vasopressor drug were given to half of the patients in the study.

    Serious adverse events
    		 Phenylephrine Ephedrine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Phenylephrine Ephedrine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    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: Yes - there were no adverse events rapported during the study.

    More information

    		 Close Top of page

    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.
    Only one RCT has been rapported in this system as the system can not managed two RCT under the same EudraCT number.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/34344019
    http://www.ncbi.nlm.nih.gov/pubmed/32482999
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 03 17:59:48 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA