UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053468 |
|---|---|
| Receipt number | R000060778 |
| Scientific Title | The geriatric trauma outcome score predicts a neurological outcome in elderly patients with head trauma |
| Date of disclosure of the study information | 2024/01/31 |
| Last modified on | 2024/08/15 23:08:19 |
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Basic information
Public title
The geriatric trauma outcome score predicts a neurological outcome in elderly patients with head trauma
Acronym
The geriatric trauma outcome score predicts a neurological outcome in elderly patients with head trauma
Scientific Title
The geriatric trauma outcome score predicts a neurological outcome in elderly patients with head trauma
Scientific Title:Acronym
The geriatric trauma outcome score predicts a neurological outcome in elderly patients with head trauma
Region
| Japan |
Condition
Condition
head trauma
Classification by specialty
| Neurosurgery | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to show that the geriatric trauma outcome score could predict a neurological outcome in elderly patients with head trauma.
We analyzed the association between the geriatric trauma outcome score and neurological outcomes using retrospective data from medical records.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is a favorable neurological outcome defined as cerebral performance category 1 or 2.
Key secondary outcomes
The secondary outcome is mortality.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We include elderly patients who visited the emergency department and were admitted to our hospital with the diagnosis of head trauma between January 2019 and August 2023.
Key exclusion criteria
Patients were excluded if they died in the ER and were diagnosed with chronic subdural hematoma (C-SDH) or non-traumatic diseases. Only first-admission data were analyzed if patients had been admitted to the intensive care unit (ICU) multiple times.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Hayahshi |
Organization
Japan Red Cross Narita Hospital
Division name
Emergency and Critical Care
Zip code
286-8523
Address
90-1, Iida-cho, Narita, Chiba
TEL
0476-22-2311
yosukehayashi19851117@gmail.com
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Hayashi |
Organization
Japan Red Cross Narita Hospital
Division name
Emergency and Critical Care
Zip code
286-8523
Address
90-1, Iida-cho, Narita, Chiba
TEL
0476-22-2311
Homepage URL
yosukehayashi19851117@gmail.com
Sponsor or person
Institute
The Japan Red Cross Narita Hospital Certified Clinical Research Review Board
Institute
Department
Personal name
Yosuke Hayashi
Funding Source
Organization
None
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
The Japan Red Cross Narita Hospital Certified Clinical Research Review Board
Address
90-1, Iida-cho, Narita, Chiba
Tel
0476-22-2311
yosukehayashi19851117@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
313
Results
A total of 313 elderly patients with head trauma were eligible for analysis. Multivariate logistic regression analysis revealed that the geriatric trauma outcome score was significantly associated with a favorable neurological outcome at discharge (odds ratio 0.94, P <0.0001). In the receiver operating characteristic curve analysis, the geriatric trauma outcome score had a good predictive value for favorable neurological outcomes at discharge (area under the receiver operating characteristic curve 0.83).
Results date posted
| 2024 | Year | 08 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 08 | Month | 13 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2024 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 08 | Month | 05 | Day |
Other
Other related information
This protcol
Management information
Registered date
| 2024 | Year | 01 | Month | 29 | Day |
Last modified on
| 2024 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060778
