Clinical Trial Results:
Effects of Hyperoxia on Haemostasis, Inflammation and
oxidative Stress
Summary
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EudraCT number |
2015-003962-10 |
Trial protocol |
AT |
Global end of trial date |
31 Dec 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
12 Jul 2020
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First version publication date |
12 Jul 2020
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Other versions |
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 |
DOA_HO
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Medical University of Vienna
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Sponsor organisation address |
Spitalgasse 23, Vienna, Austria, 1090
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Public contact |
Department of Anaesthesia, Medical University of Vienna, 0043 14040041440, gisela.scharbert@meduniwien.ac.at
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Scientific contact |
Department of Anaesthesia, Medical University of Vienna, 0043 14040041440, gisela.scharbert@meduniwien.ac.at
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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 |
13 Dec 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Dec 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Dec 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 |
Hyperoxia induces ROS in leucocytes
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Protection of trial subjects |
Stress monitoring (ECG, bloodpressure) during inhalation
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Background therapy |
none | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Apr 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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 |
Austria: 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) |
30
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
For recruitment information sheets were placed at the Medical University of Vienna | |||||||||
Pre-assignment
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Screening details |
Peripheral venipuncture was performed to determine blood count and confirm the absences of liver diseases, kidney diseases, and coagulation disorders. | |||||||||
Period 1
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Period 1 title |
Inhalation (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Data analyst | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Intervention A | |||||||||
Arm description |
Inhalation 100% Oxygen for 20 minutes 3 weeks wash out period Inhalation 21% Oxygen for 20 minutes | |||||||||
Arm type |
Cross-Over Intervention A | |||||||||
Investigational medicinal product name |
Oxygen MedicAL 100% (V/V)
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Investigational medicinal product code |
6948638.00.00
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Other name |
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Pharmaceutical forms |
Medicinal gas, compressed
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Routes of administration |
Inhalation use
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Dosage and administration details |
20 minutes inhalation of 100% medical oxygen
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Investigational medicinal product name |
Air synthetical medical AIR LIQUIDE
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Investigational medicinal product code |
PL1
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Other name |
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Pharmaceutical forms |
Medicinal gas, compressed
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Routes of administration |
Inhalation use
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Dosage and administration details |
20 minutes inhalation of Air synthetical medical gas: Oxygen 21-22,5% O2 Nitrogen 77,5-79,0% N2
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Arm title
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Intervention B | |||||||||
Arm description |
Inhalation 21% Oxygen for 20 minutes 3 weeks wash out period Inhalation 100% Oxygen for 20 minutes | |||||||||
Arm type |
Cross-Over Intervention B | |||||||||
Investigational medicinal product name |
Oxygen MedicAL 100% (V/V)
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Investigational medicinal product code |
6948638.00.00
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Other name |
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Pharmaceutical forms |
Medicinal gas, compressed
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Routes of administration |
Inhalation use
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Dosage and administration details |
20 minutes inhalation of 100% medical oxygen
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Investigational medicinal product name |
Air synthetical medical AIR LIQUIDE
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Investigational medicinal product code |
PL1
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Other name |
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Pharmaceutical forms |
Medicinal gas, compressed
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Routes of administration |
Inhalation use
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Dosage and administration details |
20 minutes inhalation of Air synthetical medical gas: Oxygen 21-22,5% O2 Nitrogen 77,5-79,0% N2
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Baseline characteristics reporting groups
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Reporting group title |
Inhalation
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Reporting group description |
- | ||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Intervention A
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Reporting group description |
Inhalation 100% Oxygen for 20 minutes 3 weeks wash out period Inhalation 21% Oxygen for 20 minutes | ||
Reporting group title |
Intervention B
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Reporting group description |
Inhalation 21% Oxygen for 20 minutes 3 weeks wash out period Inhalation 100% Oxygen for 20 minutes |
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End point title |
ROS in leukocytes | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
3h
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Statistical analysis title |
Primary Endpoint | ||||||||||||
Comparison groups |
Intervention A v Intervention B
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Number of subjects included in analysis |
30
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Analysis specification |
Post-hoc
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Analysis type |
other [1] | ||||||||||||
P-value |
≤ 0.025 | ||||||||||||
Method |
ANOVA | ||||||||||||
Confidence interval |
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Notes [1] - cross-over ANOVA model with random patient factor and adjusting for period and baseline value |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Continuously during study
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Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
23
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Frequency threshold for reporting non-serious adverse events: 0% | |||
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: no non-serious adverse events are recorded |
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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. | |||
None reported |