UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056419 |
|---|---|
| Receipt number | R000064465 |
| Scientific Title | Transcatheter Arterial Embolization for Blunt Splenic Injury: Incidence of Pseudoaneurysms and Additional Embolization |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2024/12/10 19:15:39 |
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Basic information
Public title
Transcatheter Arterial Embolization for Blunt Splenic Injury: Incidence of Pseudoaneurysms and Additional Embolization
Acronym
The Study of Blunt Splenic Injury
Scientific Title
Transcatheter Arterial Embolization for Blunt Splenic Injury: Incidence of Pseudoaneurysms and Additional Embolization
Scientific Title:Acronym
Transcatheter Arterial Embolization for Blunt Splenic Injury: Incidence of Pseudoaneurysms and Additional Embolization
Region
| Japan |
Condition
Condition
Blunt Splenic Injury
Classification by specialty
| Surgery in general | Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Transcatheter arterial embolization (TAE) is an effective treatment for blunt splenic injuries with good outcomes. However, the need for follow-up and approaches for subsequent pseudoaneurysms remains unclear. This study investigated the need for follow-up after TAE for blunt splenic injuries and additional embolization of pseudoaneurysms.
Basic objectives2
Others
Basic objectives -Others
Transcatheter arterial embolization (TAE) is an effective treatment for blunt splenic injuries with good outcomes. However, the need for follow-up and approaches for subsequent pseudoaneurysms remains unclear. This study investigated the need for follow-up after TAE for blunt splenic injuries and additional embolization of pseudoaneurysms.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of Pseudoaneurysms
Key secondary outcomes
Incidence of Additional Embolization
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with blunt splenic injuries who were transported to our hospital between 2018 and 2023
Key exclusion criteria
The exclusion criteria were as follows: failure to obtain consent for participation, patients presenting with cardiac arrest upon arrival, those who did not undergo contrast-enhanced CT, those who declined active treatment, or those who had missing data.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Fuminori |
| Middle name | |
| Last name | Yamaji |
Organization
Gifu University Hospital
Division name
Advanced Critical Care Center
Zip code
501-1194
Address
1-1 Yanagido, Gifu
TEL
0582306448
g.yama.fumi@gmail.com
Public contact
Name of contact person
| 1st name | Fuminori |
| Middle name | |
| Last name | Yamaji |
Organization
Gifu University Hospital
Division name
Advanced Critical Care Center
Zip code
501-1194
Address
1-1 Yanagido, Gifu
TEL
0582306448
Homepage URL
g.yama.fumi@gmail.com
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Medical Ethics Committee of the Gifu University Graduate School of Medicine, Gifu, Japan
Address
1-1 Yanagido,Gifu
Tel
0582306059
rinri@t.gifu-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 31 | 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
66
Results
This study included 66 patients (mean age 41 years). The causes of injury included traffic accidents (28 patients), falls from heights (20 patients), snowboarding-related trauma (10 patients), and other causes (eight patients). According to the 2018 revised American Association for the Surgery of Trauma-Organ Injury Scale, there were 14, 10, 16, 17, and 9 grade I, II, III, IV, and V injuries, respectively.
Results date posted
| 2024 | Year | 12 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
The electronic medical records of patients with blunt splenic injuries who were transported to our hospital between 2018 and 2023 were retrospectively reviewed.
Adverse events
None
Outcome measures
The primary outcome was the incidence of pseudoaneurysm. The secondary outcome was the implementation of additional embolization procedures.
Plan to share IPD
None
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 12 | Month | 10 | Day |
Last modified on
| 2024 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064465
