UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058824 |
|---|---|
| Receipt number | R000066052 |
| Scientific Title | A systematic review of the effectiveness of early surgical intervention for blunt thoracic aortic injury |
| Date of disclosure of the study information | 2025/08/20 |
| Last modified on | 2025/08/18 17:30:25 |
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Basic information
Public title
Does emergent surgical intervention should be performed for blunt thoracic aortic injury?
Acronym
Early surgical intervention for Blunt thoracic aortic injury
Scientific Title
A systematic review of the effectiveness of early surgical intervention for blunt thoracic aortic injury
Scientific Title:Acronym
SR on early surgical intervention for blunt thoracic aortic injury
Region
| Japan |
Condition
Condition
Blunt thoracic aortic injury (BTAI) (AAST grade I, II, III)
Classification by specialty
| Surgery in general | Vascular surgery | Cardiovascular surgery |
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this systematic review is to clarify the effect of early surgical intervention on outcomes such as mortality, paraplegia, endoleak/migration, and other complications, blood loss, and length of ICU stay in patients with blunt thoracic aortic injury (AAST grade I, II, III) compared with conservative treatment or elective surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mortality,
paraplegia, endoleak/migration, and other complications,
blood loss,
length of ICU stay
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with blunt thoracic aortic injury (AAST grade I, II, III)
Key exclusion criteria
Studies not primarily focusing on blunt thoracic aortic injury
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Uchida |
Organization
Osaka Metropolitan University Hospital
Division name
Trauma and Critical Care Center
Zip code
545-8586
Address
1-5-7, Asahimachi, Abenoku, Osaka-City, Osaka, JAPAN.
TEL
06-6645-2121
k.uchida@omu.ac.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Uchida |
Organization
Osaka Metropolitan University Hospital
Division name
Trauma and Critical Care Center
Zip code
545-8586
Address
1-5-7, Asahimachi, Abenoku, Osaka-City, Osaka, JAPAN.
TEL
06-6645-2121
Homepage URL
k.uchida@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Kenichiro Uchida
Funding Source
Organization
The Japanese Association for the Surgery of Trauma
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
Osaka Metropolitan University
Address
1-4-3, Asahimachi, Abenoku, Osaka-City, Osaka, JAPAN.
Tel
06-6645-3987
k.uchida@omu.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 20 | 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
| 2025 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A systematic review of the effectiveness of early surgical intervention for blunt thoracic aortic injury
Management information
Registered date
| 2025 | Year | 08 | Month | 18 | Day |
Last modified on
| 2025 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066052
