Clinical Trial Results:
Volumekinetics for hyperoncotic albumin in burn patients as well as for healthy subjects.
Summary
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EudraCT number |
2016-000996-26 |
Trial protocol |
SE |
Global end of trial date |
31 Jan 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Feb 2025
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First version publication date |
15 Feb 2025
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Other versions |
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Summary report(s) |
Summery VAB |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
VAB1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02352378 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Region Ostergotland
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Sponsor organisation address |
University Hospital, Linköping, Sweden, 58185
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Public contact |
Burn Unit, Region Ostergotland, +46 101031154, joachim.zdolsek@regionostergotland.se
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Scientific contact |
Burn Unit, Region Ostergotland, +46 101031154, joachim.zdolsek@regionostergotland.se
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Jun 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Jan 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Jan 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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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.
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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
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Sweden: 30
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Worldwide total number of subjects |
30
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EEA total number of subjects |
30
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
28
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
Healthy subjects 15 and burn patients 15, who were able to give written and signed concent | |||||||||
Pre-assignment
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Screening details |
Healthy for healthy subjects Patients with a burnwound in need of advanced burn treatment | |||||||||
Pre-assignment period milestones
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Number of subjects started |
30 | |||||||||
Number of subjects completed |
30 | |||||||||
Period 1
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Period 1 title |
Study period 5 hours (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Healthy volunteers | |||||||||
Arm description |
Healthy volunteers | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Albumin 20%
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Investigational medicinal product code |
PR 1
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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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)
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Arm title
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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%
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Investigational medicinal product code |
PR 1
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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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)
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Baseline characteristics reporting groups
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Reporting group title |
Healthy volunteers
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Reporting group description |
Healthy volunteers | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Burns
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Reporting group description |
Burned patient in need of advanced burn care. Study performed 3 to 10 days postburn. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Healthy volunteers
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Reporting group description |
Healthy volunteers | ||
Reporting group title |
Burns
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Reporting group description |
Burned patient in need of advanced burn care. Study performed 3 to 10 days postburn. |
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End point title |
Plasma volume expansion | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
60 minutes after start of infusion, i.e. 30 minutes after end of infusion
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Statistical analysis title |
Mann-Whitney U test | ||||||||||||
Comparison groups |
Healthy volunteers v Burns
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Number of subjects included in analysis |
30
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Mann-Whitney U test | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Confidence interval |
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Variability estimate |
Standard deviation
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Adverse events information
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Timeframe for reporting adverse events |
300 minutes
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Assessment type |
Systematic | ||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||
Dictionary version |
27.1
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Reporting groups
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Reporting group title |
Subcutaneous infusion
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Reporting group description |
- | ||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
No | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/32366324 |