UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040714 |
|---|---|
| Receipt number | R000046467 |
| Scientific Title | Segmental artery injury and/or massive haemothorax due solely to spinal fractures |
| Date of disclosure of the study information | 2020/06/10 |
| Last modified on | 2022/06/12 09:27:30 |
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Basic information
Public title
Segmental artery injury and/or massive haemothorax due solely to spinal fractures
Acronym
Segmental artery injury and/or massive haemothorax due solely to spinal fractures
Scientific Title
Segmental artery injury and/or massive haemothorax due solely to spinal fractures
Scientific Title:Acronym
Segmental artery injury and/or massive haemothorax due solely to spinal fractures
Region
| Japan |
Condition
Condition
Lumbar and thoracic spinal fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the incidence and features in diagnosis and treatment of segmental artery injury and massive hemothorax due solely to spinal fractures.
Basic objectives2
Others
Basic objectives -Others
To let traumatologists and orthopedic surgeons know this pathology.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
age, sex, incidence, injury severity score, levels of spinal fractures, type of fracture, presence or absence of DISH, neurological findings, treatment, and results
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Segmental artery injury and massive hemothorax due solely to thoracolumbar spinal fractures
Key exclusion criteria
segmental artery injury or massive hemothorax due to thoracic injury in multiple trauma patients
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Masanari |
| Middle name | |
| Last name | Takami |
Organization
Wakayama Medical University
Division name
Orthopaedic surgery
Zip code
6418510
Address
811-1 Kimiidera, Wakayama
TEL
0734410645
takami@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masanari |
| Middle name | |
| Last name | Takami |
Organization
Wakayama Medical University
Division name
Orthopaedic surgery
Zip code
6418510
Address
811-1 Kimiidera, Wakayama
TEL
0734410645
Homepage URL
takami@wakayama-med.ac.jp
Sponsor or person
Institute
Dept. of Orthop. Surg., Wakayama Medical Univ.
Institute
Department
Personal name
Funding Source
Organization
Dept. of Orthop. Surg., Wakayama Medical Univ.
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
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama
Tel
0734472300
wa-rinri@wakayama-med.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
| 2020 | Year | 06 | 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
202
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
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
From January 2009 to December 2019, 202 consecutive cases of emergency transfer to our hospital diagnosed with thoracic fracture were investigated. For patients with segmental artery injury and massive hemothorax due to thoracic fracture, the survey items were incidence, mechanism of injury, level of spinal fracture, fracture type, neurological symptoms, presence of diffuse idiopathic skeletal hyperostosis (DISH), treatment method, and outcome were investigated.
Management information
Registered date
| 2020 | Year | 06 | Month | 10 | Day |
Last modified on
| 2022 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046467
