UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053486 |
|---|---|
| Receipt number | R000061048 |
| Scientific Title | Association between CT Volumetry and Intracranial Pressure Elevation in Traumatic Brain Injury; A Retrospective Cohort Study. |
| Date of disclosure of the study information | 2024/01/30 |
| Last modified on | 2024/01/30 23:00:35 |
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Basic information
Public title
Association between CT Volumetry and Intracranial Pressure Elevation in Traumatic Brain Injury; A Retrospective Cohort Study.
Acronym
Association between CT Volumetry and Intracranial Pressure Elevation in Traumatic Brain Injury; A Retrospective Cohort Study.
Scientific Title
Association between CT Volumetry and Intracranial Pressure Elevation in Traumatic Brain Injury; A Retrospective Cohort Study.
Scientific Title:Acronym
Association between CT Volumetry and Intracranial Pressure Elevation in Traumatic Brain Injury; A Retrospective Cohort Study.
Region
| Japan |
Condition
Condition
Traumatic brain injury
Classification by specialty
| Neurosurgery | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intracranial pressure (ICP) elevation is associated with poor outcome in patients with traumatic brain injury (TBI), and ICP is one of the key indicators in the management of TBI patient. Although ICP elevation is sometimes estimated from CT images as a substitute for ICP sensor placement, the association between CT images and ICP elevation remains unclear. This study aims to objectively elucidate this association through the utilization of a freely available programming code for CT assessment.
Basic objectives2
Others
Basic objectives -Others
Predictive/diagnostic research
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Intracranial pressure
Key secondary outcomes
Mortality rate (24-hour, 30-day, in-hospital)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with traumatic brain injuries who have undergone the insertion of an intracranial pressure sensor.
Key exclusion criteria
Patients who have undergone craniotomy prior to the insertion of an intracranial pressure sensor.
Patients with CT images that pose technical challenges for evaluation.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
School of Public Health, Graduate School of Medicine, Kyoto University
Division name
Department of Preventive Services
Zip code
606-8501
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
TEL
075-753-4400
iwami.taku.8w@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Ninomiya |
Organization
School of Public Health, Graduate School of Medicine, Kyoto University
Division name
Department of Preventive Services
Zip code
606-8501
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
TEL
075-753-4400
Homepage URL
kn.12691@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Kohei Ninomiya
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
りんくう総合医療センター(大阪府)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will conduct a retrospective cohort study at Rinku General Medical Center in Japan from April 2014 to August 2023, including all ages of traumatic brain injury (TBI) patients with inserted intracranial pressure (ICP) sensors. ICP values will be compared with CT series taken at the same timing. The 'CT volumetry' will be employed to analyze CT series, visualizing and calculating intracranial volume (ICV) and three density volumes: low-density volume (LDV), middle-density volume (MDV), and high-density volume (HDV). The thresholds for the density areas will be determined as averages by three blinded trauma physicians. The code was developed using Python and the OpenCV module, enabling cost-free and versatile utilization. The primary outcome is ICP value, and we establish an ICP elevation threshold (ICP > 22mmHg) for a dichotomous outcome to assess diagnostic accuracy.
Management information
Registered date
| 2024 | Year | 01 | Month | 30 | Day |
Last modified on
| 2024 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061048
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