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    Clinical Trial Results:
    Volumekinetics for hyperoncotic albumin in burn patients as well as for healthy subjects.

    Summary
    EudraCT number
    		 2016-000996-26
    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 VAB

    Trial information

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    Trial identification
    Sponsor protocol code
    VAB1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02352378
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Region Ostergotland
    Sponsor organisation address
    University Hospital, Linköping, 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
    30 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jan 2019
    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 intravenously administered hyperoncotic albumin can attract fluid from the interstitium to the cirkulation in healthy individuals and in burn patients.
    Protection of trial subjects
    Trial subjects were monitored with ECG and Saturation (oxygen) and intermittent (continous if they had an arterial line) blodpressure. When registered in compure programs (Excel) the id of the trial subject was deindetified.
    Background therapy
    		 Albumin solution is commonly used in treatment of hypovolemia or in during the deresusitation phase in the intensive care setting.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2016
    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: 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)
    28
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy subjects 15 and burn patients 15, who were able to give written and signed concent

    Pre-assignment
    Screening details
    		 Healthy for healthy subjects Patients with a burnwound in need of advanced burn treatment

    Pre-assignment period milestones
    Number of subjects started
    		 30
    Number of subjects completed
    		 30

    Period 1
    Period 1 title
    Study period 5 hours (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Healthy volunteers
    Arm description
    		 Healthy volunteers
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Albumin 20%
    Investigational medicinal product code
    PR 1
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3ml per kilo bodyweight of Albumin 20% which is 600mg albumin for every kilo body weight (For a person of 70 kilo bodyweight this will be a mass of 42 g albumin)

    Arm title
    		 Burns
    Arm description
    		 Burned patient in need of advanced burn care. Study performed 3 to 10 days postburn.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Albumin 20%
    Investigational medicinal product code
    PR 1
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3ml per kilo bodyweight of Albumin 20% which is 600mg albumin for every kilo body weight (For a person of 70 kilo bodyweight this will be a mass of 42 g albumin)

    Number of subjects in period 1
    		Healthy volunteers Burns
    Started
    15
    15
    Completed
    15
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Healthy volunteers
    Reporting group description
    		 Healthy volunteers

    Reporting group title
    Burns
    Reporting group description
    		 Burned patient in need of advanced burn care. Study performed 3 to 10 days postburn.

    Reporting group values
    		 Healthy volunteers Burns Total
    Number of subjects
    		 15 15 30
    Age categorical
    Health volunteers and burn patients
    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)
    		 15 13 28
        From 65-84 years
    		 0 2 2
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (standard deviation)
    		 31 ( 12 ) 45 ( 15 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 3 9
        Male
    		 9 12 21

    End points

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    End points reporting groups
    Reporting group title
    Healthy volunteers
    Reporting group description
    		 Healthy volunteers

    Reporting group title
    Burns
    Reporting group description
    		 Burned patient in need of advanced burn care. Study performed 3 to 10 days postburn.

    Primary: Plasma volume expansion

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    End point title
    		 Plasma volume expansion
    End point description
    End point type
    Primary
    End point timeframe
    60 minutes after start of infusion, i.e. 30 minutes after end of infusion
    End point values
    		 Healthy volunteers Burns
    Number of subjects analysed
    15
    15
    Units: L
        arithmetic mean (standard deviation)
    0.43 ( 0.18 )
    0.59 ( 0.22 )
    Statistical analysis title
    		 Mann-Whitney U test
    Comparison groups
    Healthy volunteers v Burns
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mann-Whitney U test
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    300 minutes
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Subcutaneous infusion
    Reporting group description
    		 -

    Serious adverse events
    		 Subcutaneous infusion
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (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
    		 Subcutaneous infusion
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Skin and subcutaneous tissue disorders
    subcutaneous infusion
    Additional description: Subcutaneous infusion. Infusion was discontinued and the subject returned at a later occasion.
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32366324
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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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