UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043751 |
|---|---|
| Receipt number | R000044320 |
| Scientific Title | Complications of spinal drainage for thoracic aortic aneurysm -a retrospective analysis- |
| Date of disclosure of the study information | 2021/03/26 |
| Last modified on | 2023/05/19 11:57:36 |
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Basic information
Public title
Complications of spinal drainage for thoracic aortic aneurysm -a retrospective analysis-
Acronym
Complications of spinal drainage
Scientific Title
Complications of spinal drainage for thoracic aortic aneurysm -a retrospective analysis-
Scientific Title:Acronym
Complications of spinal drainage
Region
| Japan |
Condition
Condition
Thoracic aortic aneurysm
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the incidence rate of complications of spinal drainage for thoracic aortic aneurysm
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence rate of complications
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
Patients who were scheduled to undergo surgeries for thoracic aortic aneurysm in whom spinal drainage catheter placement by anesthesiologists was performed
Key exclusion criteria
Postoperative spinal drainage catheter placement due to the symptom of paraplegia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Sugiyama |
Organization
Shinshu University Hospital
Division name
Anesthesiology and Resuscitology
Zip code
390-8621
Address
Asahi 3-1-1, Matsumoto, Nagano
TEL
0263-37-2670
ysugiyama@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Sugiyama |
Organization
Shinshu University
Division name
Anesthesiology and Resuscitology
Zip code
390-8621
Address
Asahi 3-1-1, Matsumoto, Nagano
TEL
0263-37-2670
Homepage URL
ysugiyama@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Shinshu University School of Medicine
Address
Asahi 3-1-1, Matsumoto, Nagano
Tel
0263-37-2572
mdrinri@shinshu-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
| 2021 | Year | 03 | Month | 26 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00540-022-03077-0
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00540-022-03077-0
Number of participants that the trial has enrolled
123
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
| 2019 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective analysis
Management information
Registered date
| 2021 | Year | 03 | Month | 26 | Day |
Last modified on
| 2023 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044320
