Clinical Trial Results:
Minimizing contrast agent in computed tomography pulmonary angiography
Summary
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EudraCT number |
2015-004657-40 |
Trial protocol |
SE |
Global end of trial date |
01 May 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Dec 2021
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First version publication date |
02 Dec 2021
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Other versions |
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Summary report(s) |
CTPA2015 report abstract |
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 |
CTPA-2015
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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 |
Region Örebro län
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Sponsor organisation address |
Universitetssjukhuset Örebro, Örebro, Sweden,
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Public contact |
Mats Lidén, Region Örebro län, +46 196020370, mats.liden@regionorebrolan.se
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Scientific contact |
Mats Lidén, Region Örebro län, +46 196020370, mats.liden@regionorebrolan.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 |
05 Mar 2020
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
01 May 2020
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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 develop and evaluate a computed tomography protocol for ruling out pulmonary embolism using a minimal amount of contrast medium.
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Protection of trial subjects |
All contrast media utilization for subjects in the study followed national and European guidelines for use of iodinated contrast media in computed tomography.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Sep 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: 55
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Worldwide total number of subjects |
55
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EEA total number of subjects |
55
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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) |
14
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From 65 to 84 years |
40
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85 years and over |
1
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Recruitment
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Recruitment details |
- | ||||||
Pre-assignment
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Screening details |
Patients with planned contrast media enhanced chest CT at the study site were screened for participation and 55 participants were included in this single arm study. | ||||||
Period 1
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Period 1 title |
Overall (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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Arm title
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Single arm | ||||||
Arm description |
Development and evaluation of contrast media protocol | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Omnipaque
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
Single dosage corresponding to up to 80 mg iodine/ kg body weight. Maximum total dosage in study was 20 mL Omnipaque 350 mg/mL.
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Baseline characteristics reporting groups
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Reporting group title |
Overall
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Single arm
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Reporting group description |
Development and evaluation of contrast media protocol |
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End point title |
Image quality [1] | ||||||||||||||
End point description |
Subjective image quality considering pulmonary embolism.
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End point type |
Primary
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End point timeframe |
The image quality was independently assessed by three blinded readers in a separate reading.
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The statistical analysis was the proportion of images with at least adequate image quality, with no comparison groups. |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Any acute adverse events following contrast media administration were identified before the participant left the radiology department.
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
Not used | ||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
Overall
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Reporting group description |
- | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
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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 encountered. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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01 Mar 2017 |
Change in inclusion criteria. |
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/32436788 |