UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041296 |
|---|---|
| Receipt number | R000046348 |
| Scientific Title | Natural history and practice pattern of blunt splenic and hepatic injury in children: A Japan Trauma Association multi-institutional study |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2023/02/25 10:06:52 |
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Basic information
Public title
Natural history and practice pattern of blunt splenic and hepatic injury in children: A Japanese Association for Surgery of Trauma multi-institutional observational study
Acronym
Blunt splenic and hepatic injury in children
Scientific Title
Natural history and practice pattern of blunt splenic and hepatic injury in children: A Japan Trauma Association multi-institutional study
Scientific Title:Acronym
Natural history and practice pattern of blunt splenic and hepatic injury in children
Region
| Japan |
Condition
Condition
Blunt splenic and hepatic injury in children
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery | Pediatrics |
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the natural history and practice pattern of blunt splenic and hepatic injury in children.
Basic objectives2
Others
Basic objectives -Others
To determine the association between therapeutic interventions and outcomes for pediatric patients of blunt splenic and hepatic injury.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood transfusion requirement
Pseudoaneurysm formation
Key secondary outcomes
Spleen preservation rate
Failure of non-operative management
radiation exposure
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
| Not applicable |
Age-upper limit
| 16 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
This study will include subjects aged 16 years and more with an acute blunt
splenic and/or hepatic injury. Eligible patients will be included those admitted to an emergency
care setting for at least 24 h with AAST grade I and more splenic and/or hepatic
injury detected by any imaging method.
Key exclusion criteria
1. CPA on arrival
2. with AIS 6 of any part of the body
3. Refuse or limited forms of aggressive treatment due to severe head injury (Head AIS more than 5 etc)
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Kushimoto |
Organization
Tohoku University School of medicine
Division name
Emergency and Critical Care Medicine
Zip code
9808574
Address
Seiryotyo 1-1, Aoba, Sendai, Miyagi, Japan
TEL
0227177489
kussie@emergency-medicine.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Morihiro |
| Middle name | |
| Last name | Katsura |
Organization
Okinawa Chubu Hospital
Division name
Department of Surgery
Zip code
9042293
Address
Miyazato 281, Uruma city, Okinawa, Japan
TEL
0989734111
Homepage URL
morihiro@bj8.so-net.ne.jp
Sponsor or person
Institute
Japanese Association for Surgery of Trauma
Institute
Department
Personal name
Funding Source
Organization
None
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
Japanese Association for Surgery of Trauma
Address
Okubo 2-4-12, Shinjuku, Tokyo, Japan
Tel
0352916259
jast@shunkosha.com
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
| 2020 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.jast-hp.org/syourai/index6.html
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/jtrauma/Fulltext/2023/03000/Therapeutic_strategies_for_pseudoaneurysm.11.as
Number of participants that the trial has enrolled
1407
Results
A total of 1,407 children from 83 institutions were included. Patients treated with NOM, NOM with IR, OM, and combined IR/OM developed 4.1%, 12%, 3.8%, and 14% delayed pseudoaneurysms, respectively. Among patients who developed any pseudoaneurysms, 39% underwent prophylactic IR for unruptured pseudoaneurysm, while 13% required emergency angioembolization for delayed pseudoaneurysm rupture. At least 45% of patients experienced spontaneous resolution of pseudoaneurysm without any interventions.
Results date posted
| 2023 | Year | 02 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 1407 patients, 821 had a liver injury, 532 had a spleen injury, and 54 had both liver and spleen injuries. Median age was 9, 67% were male, and median ISS was 10 among the overall cohort. The department most commonly in charge of treatment was adult emergency medicine (51%), followed by pediatric surgery (20%), and adult surgery (15%).
Participant flow
A total of 1462 pediatric patients were admitted with a diagnosis of BLSI to 83 participating centers between 2008 and 2019, of whom 1407 met our eligibility criteria. Study data were collected and managed through the REDCap (Research Electronic Data Capture) tool. Anonymized data were entered manually by local researchers.
Adverse events
None
Outcome measures
pseudoaneurysm (incidence, therapeutic strategies), in-hospital mortality, transfusion requirement
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2020 | Year | 08 | Month | 03 | Day |
Last modified on
| 2023 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046348
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