UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057569 |
|---|---|
| Receipt number | R000065776 |
| Scientific Title | Systematic Review on the Effectiveness of Open Reduction and Internal Fixation versus TAE (via IVR) or External Carotid Artery Ligation for Hemorrhagic Shock Due to Facial Fractures |
| Date of disclosure of the study information | 2025/04/10 |
| Last modified on | 2025/04/09 19:13:53 |
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Basic information
Public title
Which Treatment Works Best When Bleeding from Facial Fractures Doesn't Stop? A Study Comparing Surgery, Catheter Embolization, and Arterial Ligation
Acronym
SR on Hemorrhage Control in Facial Fractures
Scientific Title
Systematic Review on the Effectiveness of Open Reduction and Internal Fixation versus TAE (via IVR) or External Carotid Artery Ligation for Hemorrhagic Shock Due to Facial Fractures
Scientific Title:Acronym
SR of Surgery vs IVR-TAE or ECA Ligation for Hemorrhagic Shock in Facial Fractures
Region
| Japan |
Condition
Condition
Hemorrhagic shock persisting despite tamponade with packing or ballooning for oral or nasal bleeding caused by facial bone fractures
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate, through a systematic review of the literature, whether open reduction and internal fixation (ORIF) or transarterial embolization (TAE) via interventional radiology and/or external carotid artery ligation is more effective in managing persistent hemorrhagic shock due to oral or nasal bleeding caused by facial bone fractures, despite initial tamponade using packing or balloon techniques.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Short-term mortality, Transfusion volume, Length of hospital stay, Length of ICU stay, Complications of embolization or ischemia, Time to shock resolution, Serious adverse events
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with hemorrhagic shock
Key exclusion criteria
Studies not targeting hemorrhagic shock caused by facial bone fractures
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Hirose |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Traumatology and Acute Critical Medicine
Zip code
5650871
Address
2-15 Yamadaoka Suita, Osaka
TEL
0668795707
htomoya1979@hp-emerg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Hirose |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Traumatology and Acute Critical Medicine
Zip code
5650871
Address
2-15 Yamadaoka Suita, Osaka
TEL
0668795707
Homepage URL
htomoya1979@hp-emerg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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 University Graduate School of Medicine
Address
2-15 Yamadaoka Suita, Osaka
Tel
0668795707
htomoya1979@hp-emerg.med.osaka-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 | 04 | Month | 10 | 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 | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a systematic review assessing the effectiveness of open reduction and internal fixation versus transarterial embolization (via interventional radiology) or external carotid artery ligation in patients with hemorrhagic shock due to facial fractures, unresponsive to initial tamponade using packing or balloon techniques.
As this is a literature-based systematic review rather than a clinical trial, several items in the UMIN form (e.g., intervention status, number of groups, study design) have been selected for administrative purposes only.
Management information
Registered date
| 2025 | Year | 04 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065776
