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    Clinical Trial Results:
    Prospective, controled, randomized, double blind monocentric study evaluating the efficacy of the basic component of colloids (corn versus potato) on perioperative blood losses in elective cardiac surgery.

    Summary
    EudraCT number
    		 2011-005920-16
    Trial protocol
    		 BE  
    Global end of trial date
    13 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2021
    First version publication date
    29 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CHUB-930105
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU Brugmann
    Sponsor organisation address
    4 Place A Van Gehuchten , Brussels, Belgium, 1020
    Public contact
    Anesthesiology Department, CHU Brugmann, 32 024773996, Philippe.VANDERLINDEN@chu-brugmann.be
    Scientific contact
    Anesthesiology Department, CHU Brugmann, 32 024773996, Philippe.VANDERLINDEN@chu-brugmann.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
    13 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Security of hydroxyethyl starches
    Protection of trial subjects
    Procedures according to the standard of care.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Mar 2012
    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
    Belgium: 118
    Worldwide total number of subjects
    118
    EEA total number of subjects
    118
    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)
    54
    From 65 to 84 years
    58
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 227 patients were assessed for eligibility. 118 patients were randomized.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Maize-HES
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Volulyte 6%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Maximum dose of 50ml/kg of a 6% solution of Volulyte

    Arm title
    		 Potato-HES
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    PlasmaVolume Redibag 6%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Injection
    Dosage and administration details
    Maximum dose of 50ml/kg of the 6% Plasma Redibag solution.

    Number of subjects in period 1
    		Maize-HES Potato-HES
    Started
    59
    59
    Completed
    59
    59

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Maize-HES
    Reporting group description
    		 -

    Reporting group title
    Potato-HES
    Reporting group description
    		 -

    Reporting group values
    		 Maize-HES Potato-HES Total
    Number of subjects
    		 59 59 118
    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)
    		 32 22 54
        From 65-84 years
    		 25 33 58
        85 years and over
    		 2 4 6
    Gender categorical
    Units: Subjects
        Female
    		 16 19 35
        Male
    		 43 40 83

    End points

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    End points reporting groups
    Reporting group title
    Maize-HES
    Reporting group description
    		 -

    Reporting group title
    Potato-HES
    Reporting group description
    		 -

    Primary: Blood loss

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    End point title
    		 Blood loss
    End point description
    End point type
    Primary
    End point timeframe
    Postoperative day 2
    End point values
    		 Maize-HES Potato-HES
    Number of subjects analysed
    59
    59
    Units: ml
    504
    530
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Maize-HES v Potato-HES
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Clinical Practice
    Dictionary version
    N/A
    Reporting groups
    Reporting group title
    Maize-HES
    Reporting group description
    		 -

    Reporting group title
    Potato-HES
    Reporting group description
    		 -

    Serious adverse events
    		 Maize-HES Potato-HES
    Total subjects affected by serious adverse events
         subjects affected / exposed
    39 / 59 (66.10%)
    34 / 59 (57.63%)
         number of deaths (all causes)
    4
    4
         number of deaths resulting from adverse events
    Investigations
    Death
    Additional description: Long-term follow-up, unknown causes
         subjects affected / exposed
    2 / 59 (3.39%)
    2 / 59 (3.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Surgical and medical procedures
    Aortic rupture
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac disorders
    Cardiogenic shock
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial fibrillation
         subjects affected / exposed
    14 / 59 (23.73%)
    17 / 59 (28.81%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Stroke
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Postoperative delirium
         subjects affected / exposed
    7 / 59 (11.86%)
    2 / 59 (3.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Redo surgery for hemostasis
         subjects affected / exposed
    1 / 59 (1.69%)
    3 / 59 (5.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory insufficiency (death)
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory insufficiency
         subjects affected / exposed
    17 / 59 (28.81%)
    12 / 59 (20.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal replacement therapy
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Maize-HES Potato-HES
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 59 (13.56%)
    8 / 59 (13.56%)
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    8 / 59 (13.56%)
    8 / 59 (13.56%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 May 2015
    Protocol V1.2 - 07/05/2015 Addition of a quality of life questionnaire (MacNew score) during a telephone contact made 1 year after their surgery. Extension of the total duration of the study.

    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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