UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060391 |
|---|---|
| Receipt number | R000065686 |
| Scientific Title | A systematic review of the efficacy of intra-aortic balloon occlusion for severe trauma in adults |
| Date of disclosure of the study information | 2026/01/17 |
| Last modified on | 2026/01/17 20:56:06 |
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Basic information
Public title
A systematic review of the efficacy of intra-aortic balloon occlusion for severe trauma in adults
Acronym
The efficacy of intra-aortic balloon occlusion for severe trauma in adults
Scientific Title
A systematic review of the efficacy of intra-aortic balloon occlusion for severe trauma in adults
Scientific Title:Acronym
he efficacy of intra-aortic balloon occlusion for severe trauma in adults
Region
| Japan |
Condition
Condition
trauma
Classification by specialty
| Surgery in general | Radiology | Operative medicine |
| Emergency medicine | Blood transfusion | Intensive care medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Resuscitative Endovascular Balloon Occlusion of the Aorta (hereinafter referred to as REBOA) is a procedure used for severe trauma cases with life-threatening hemorrhage below the diaphragm. It involves the endovascular placement of a balloon to occlude the aorta, thereby maintaining hemodynamic stability until definitive hemostasis can be achieved.
Currently, its indication is limited to severe trauma cases with imminent cardiac arrest; however, there is still ongoing debate regarding the appropriate patient selection. Compared to open aortic cross-clamping, REBOA is reported to be a less invasive method of aortic occlusion, and its potential survival benefits in severe trauma cases are anticipated.
On the other hand, inappropriate patient selection or improper use of REBOA can lead to serious ischemic complications and may cause harm. In Japan, REBOA has long been used in trauma management, and determining whether its use should be recommended for severe trauma remains a critical issue. Hence, we have identified this as an important clinical challenge.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mortality (Long term, 30-day, in-hospital)
Key secondary outcomes
Complication, Achievement of hemostatic procedure, Time to definitive hemostatic procedure, Hospital length of stay, Amount of transfusion, Systolic blood pressure after REBOA inflation
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
severe trauma
Key exclusion criteria
resuscitative thoracotomy with aortic cross clamping
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Aoki |
Organization
National Defense Medical College Research Institute
Division name
Division of Traumatology
Zip code
3598513
Address
3-2, Namiki, Tokorozawa, Saitama
TEL
0429951633
aokimakoto@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Aoki |
Organization
National Defense Medical College Research Institute
Division name
Division of Traumatology
Zip code
3598513
Address
3-2 Namiki Tokorozawa
TEL
0429951633
Homepage URL
aokimakoto@ndmc.ac.jp
Sponsor or person
Institute
Japanese Association for the Surgery of Trauma
Institute
Department
Personal name
Funding Source
Organization
Japanese Association for the Surgery of Trauma
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Defense Medical College Research Institute
Address
3-2 Namiki Tokorozawa
Tel
0429951633
aokimakoto@ndmc.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
| 2026 | Year | 01 | Month | 17 | 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 | 12 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The Japanese Association for the Surgery of Trauma, Systematic Review and Meta analysis
Management information
Registered date
| 2026 | Year | 01 | Month | 17 | Day |
Last modified on
| 2026 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065686
