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    Clinical Trial Results:
    Infusion rate and volumekinetics for hyperoncotic albumin in healthy subjects (RAV), - A phase IV, randomized, open-labeled, cross-over study

    Summary
    EudraCT number
    		 2017-003687-12
    Trial protocol
    		 SE  
    Global end of trial date
    31 Jan 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Feb 2025
    First version publication date
    15 Feb 2025
    Other versions
    Summary report(s)
    		 Summery RAV

    Trial information

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    Trial identification
    Sponsor protocol code
    RAV1.2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Region Ostergotland
    Sponsor organisation address
    University Hospital, Linkoeping, Sweden, 58185
    Public contact
    Burn Unit, Region Ostergotland, +46 101031154, joachim.zdolsek@regionostergotland.se
    Scientific contact
    Burn Unit, Region Ostergotland, +46 101031154, joachim.zdolsek@regionostergotland.se
    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
    31 Dec 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study if infusion rate of intravenous administered hyperoncotic albumin is relavant for attraction of fluid from the interstitium and to compare this effect with isooncotic albumin.
    Protection of trial subjects
    Infusions were performed adjacent to the Intensive Care Unit. Vital parameters were monitored.
    Background therapy
    		 Healthy individuals
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Nov 2017
    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
    Sweden: 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)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy individuals

    Pre-assignment
    Screening details
    		 Healthy individuals

    Period 1
    Period 1 title
    Study period up to 360 minutes (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Open label randomization

    Arms
    Arm title
    		 Fast and slow infusions of albumin 20%
    Arm description
    		 Volunteers receiving 3 mL/kg of 20% albumin over 30 min (fast) and slow 120 min
    Arm type
    		 Experimental

    Investigational medicinal product name
    Albumin 20%
    Investigational medicinal product code
    B05AA01
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    3 mL/kg of 20% albumin over 30 and 120 min in a cross over fashion.

    Number of subjects in period 1
    		Fast and slow infusions of albumin 20%
    Started
    12
    Completed
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study period up to 360 minutes
    Reporting group description
    		 Healthy individuals

    Reporting group values
    		 Study period up to 360 minutes Total
    Number of subjects
    		 12 12
    Age categorical
    Age of subjects
    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)
    		 12 12
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 28 ( 10 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 6 6
    Subject analysis sets

    Subject analysis set title
    Fast infusion plasma volume expansion 0-2h
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    AUC. plasma volume expansion 0-2 h after infusion start in L min/kg.

    Subject analysis set title
    Slow infusion plasma volume expansion 0-2h
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    AUC. plasma volume expansion 0-2 h after infusion start in L min/kg.

    Subject analysis set title
    Fast infusion plasma volume expansion 0-6h
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    AUC. plasma volume expansion 0-6 h after infusion start in L min/kg.

    Subject analysis set title
    Slow infusion plasma volume expansion 0-6h
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    AUC. plasma volume expansion 0-6 h after infusion start in L min/kg.

    Subject analysis set title
    Intravascular half-life fast infusion
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Intravascular half-life for albumin after a fast infusion (30 minutes) of 3ml/kg Albumin 20%

    Subject analysis set title
    Intravascular half-life slow infusion
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Intravascular half-life for albumin after slow infusion (120 minutes) of 3ml/kg Albumin 20%

    Subject analysis sets values
    		 Fast infusion plasma volume expansion 0-2h Slow infusion plasma volume expansion 0-2h Fast infusion plasma volume expansion 0-6h Slow infusion plasma volume expansion 0-6h Intravascular half-life fast infusion Intravascular half-life slow infusion
    Number of subjects
    12
    12
    12
    12
    12
    12
    Age categorical
    Age of subjects
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    12
    12
    12
    12
        From 65-84 years
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    28 ( 10 )
    28 ( 10 )
    28 ( 10 )
    28 ( 10 )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    6
    6
    6
    6
        Male
    6
    6
    6
    6

    End points

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    End points reporting groups
    Reporting group title
    Fast and slow infusions of albumin 20%
    Reporting group description
    		 Volunteers receiving 3 mL/kg of 20% albumin over 30 min (fast) and slow 120 min

    Subject analysis set title
    Fast infusion plasma volume expansion 0-2h
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    AUC. plasma volume expansion 0-2 h after infusion start in L min/kg.

    Subject analysis set title
    Slow infusion plasma volume expansion 0-2h
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    AUC. plasma volume expansion 0-2 h after infusion start in L min/kg.

    Subject analysis set title
    Fast infusion plasma volume expansion 0-6h
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    AUC. plasma volume expansion 0-6 h after infusion start in L min/kg.

    Subject analysis set title
    Slow infusion plasma volume expansion 0-6h
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    AUC. plasma volume expansion 0-6 h after infusion start in L min/kg.

    Subject analysis set title
    Intravascular half-life fast infusion
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Intravascular half-life for albumin after a fast infusion (30 minutes) of 3ml/kg Albumin 20%

    Subject analysis set title
    Intravascular half-life slow infusion
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Intravascular half-life for albumin after slow infusion (120 minutes) of 3ml/kg Albumin 20%

    Primary: Plasmavolume expansion 120 minutes

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    End point title
    		 Plasmavolume expansion 120 minutes
    End point description
    Difference in AUC for volume expansion for the 30 and the 120 minute infusions.
    End point type
    Primary
    End point timeframe
    120 minutes after start of infusions.
    End point values
    		 Fast infusion plasma volume expansion 0-2h Slow infusion plasma volume expansion 0-2h
    Number of subjects analysed
    12
    12
    Units: L min/kg
        median (inter-quartile range (Q1-Q3))
    0.44 (0.40 to 0.65)
    0.26 (0.19 to 0.42)
    Statistical analysis title
    		 Difference in volume expansion during the first 2
    Comparison groups
    Fast infusion plasma volume expansion 0-2h v Slow infusion plasma volume expansion 0-2h
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.15
         upper limit
    		 0.8
    Variability estimate
    Standard deviation

    Primary: Plasma volume expansion 360 minutes

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    End point title
    		 Plasma volume expansion 360 minutes
    End point description
    Comparison plasma volume expansion during 360 minute for a fast infusion (30 minutes) an a slow infusion (120 minutes)
    End point type
    Primary
    End point timeframe
    From start of infusions to the end of the study 360 minutes later
    End point values
    		 Fast infusion plasma volume expansion 0-6h Slow infusion plasma volume expansion 0-6h
    Number of subjects analysed
    12
    12
    Units: L min/kg
        median (inter-quartile range (Q1-Q3))
    1.08 (0.73 to 1.90)
    0.97 (0.67 to 1.68)
    Statistical analysis title
    		 Volume expansion from start to end of the study.
    Statistical analysis description
    Volume expansion during the entire study 0 to 360 minutes for both infusions. Fast (30 minutes) and slow (120 minutes)
    Comparison groups
    Slow infusion plasma volume expansion 0-6h v Fast infusion plasma volume expansion 0-6h
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.31 [1]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.8
    Notes
    [1] - Difference between the infusion not significant.

    Secondary: Intravascular half life for slow and fast infusions of hyperoncotic albumin

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    End point title
    		 Intravascular half life for slow and fast infusions of hyperoncotic albumin
    End point description
    End point type
    Secondary
    End point timeframe
    Calculations from measurements during observation from start of infusion up to 360 minutes later.
    End point values
    		 Intravascular half-life fast infusion Intravascular half-life slow infusion
    Number of subjects analysed
    12
    12
    Units: h
        median (inter-quartile range (Q1-Q3))
    8.0 (5.4 to 11.6)
    6.3 (4.4 to 8.4)
    Statistical analysis title
    		 Difference in half life depending on infusion rate
    Comparison groups
    Intravascular half-life fast infusion v Intravascular half-life slow infusion
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.028
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From start of infusion to end of study 260 minutes later
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    None
    Reporting group description
    		 -

    Serious adverse events
    		 None
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 None
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    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: There were no adverse events.

    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.
    No limitations associated with the performance of the study.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/92941
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