UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059701 |
|---|---|
| Receipt number | R000068283 |
| Scientific Title | Mortality Impact of REBOA: A Systematic Review and Meta-analysis of Geographic and Patient Population Differences |
| Date of disclosure of the study information | 2025/12/25 |
| Last modified on | 2025/12/08 20:57:37 |
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Basic information
Public title
Mortality Impact of REBOA: A Systematic Review and Meta-analysis of Geographic and Patient Population Differences
Acronym
Mortality Impact of REBOA: A Systematic Review and Meta-analysis of Geographic and Patient Population Differences
Scientific Title
Mortality Impact of REBOA: A Systematic Review and Meta-analysis of Geographic and Patient Population Differences
Scientific Title:Acronym
Mortality Impact of REBOA: A Systematic Review and Meta-analysis of Geographic and Patient Population Differences
Region
| Japan | Asia(except Japan) | North America |
| Europe |
Condition
Condition
Patients with hemorrhagic shock and cardiovascular collapse treated with REBOA
Classification by specialty
| Vascular surgery | Obstetrics and Gynecology | Radiology |
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this paper is to determine the impact of REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta) on mortality in patients with hemorrhagic shock and cardiovascular collapse.
Compare mortality rates between patients who received REBOA and those who did not (non-REBOA).
Analyze whether this impact on mortality differs based on patient populations (trauma vs. non-trauma) or geographic regions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We conduct a systematic review and meta-analysis of observational studies comparing mortality between patients receiving REBOA and those managed without REBOA. Pooled odds ratios (ORs) and 95% confidence intervals (CIs) are calculated using random-effects models.
Key secondary outcomes
Subgroup analyses are performed according to propensity score (PS) matching, trauma versus non-trauma populations, and geographic regions.
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 and cardiovascular collapse treated with REBOA.
Key exclusion criteria
No special remarks
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kamide |
Organization
Yokohama City University Medical Center
Division name
Department of Diagnostic Radiology
Zip code
2320024
Address
4-57 Urafunecho, Minami Ward, Yokohama, Kanagawa
TEL
0452615656
kamide.hir.xr@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kamide |
Organization
Yokohama City University Medical Center
Division name
Department of Diagnostic Radiology
Zip code
232-0024
Address
4-57 Urafunecho, Minami Ward, Yokohama, Kanagawa
TEL
0452615656
Homepage URL
kamide.hir.xr@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Medical Center
Address
4-57 Urafunecho, Minami Ward, Yokohama, Kanagawa
Tel
0452615656
kamide.hir.xr@yokohama-cu.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 | 12 | Month | 25 | 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 | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We conduct a comprehensive literature search using the PubMed, Web of Science, and Cochrane Library databases to identify studies evaluating the impact of resuscitative endovascular balloon occlusion of the aorta (REBOA) on patient mortality.
Management information
Registered date
| 2025 | Year | 11 | Month | 08 | Day |
Last modified on
| 2025 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068283
