UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056837 |
|---|---|
| Receipt number | R000060737 |
| Scientific Title | A retrospective study of patients with spinal cord ischemia after cardiovascular surgery |
| Date of disclosure of the study information | 2025/01/31 |
| Last modified on | 2025/01/27 17:33:03 |
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Basic information
Public title
A retrospective study of patients with spinal cord ischemia after cardiovascular surgery
Acronym
A retrospective study of patients with spinal cord ischemia after cardiovascular surgery
Scientific Title
A retrospective study of patients with spinal cord ischemia after cardiovascular surgery
Scientific Title:Acronym
A retrospective study of patients with spinal cord ischemia after cardiovascular surgery
Region
| Japan |
Condition
Condition
Thoracic aortic and thoracoabdominal aortic vascular disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to identify factors related to the development of paraplegia in our university. We will also examine factors affecting long-term prognosis (height, gender, surgical procedure, surgical time, and medical history).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint will be whether or not paraplegia develops.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing thoracic aortic and thoracoabdominal aortic vascular surgery
Key exclusion criteria
None
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Nakajima |
Organization
Sapporo Medical University
Division name
Cardiovascular surgery
Zip code
060-8543
Address
Sapporo City South 1 West 16
TEL
011-611-2111
t.nakajima@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Nakajima |
Organization
Sapporo Medical University
Division name
Cardiovascular surgery
Zip code
0608543
Address
Sapporo City South 1 West 16
TEL
0116112111
Homepage URL
t.nakajima@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical 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
Sapporo Medical University
Address
Sapporo City South 1 West 16
Tel
011-611-2111
t.nakajima@sapmed.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 | 01 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 01 | Month | 27 | Day |
Last modified on
| 2025 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060737
