UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033525 |
|---|---|
| Receipt number | R000038229 |
| Scientific Title | Efficacy of emergent cerebrospinal fluid drainage on spinal cord injury after aortic aneurysm repair |
| Date of disclosure of the study information | 2018/07/30 |
| Last modified on | 2018/07/26 16:02:49 |
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Basic information
Public title
Efficacy of emergent cerebrospinal fluid drainage on spinal cord injury after aortic aneurysm repair
Acronym
Emergent cerebrospinal fluid drainage after aortic aneurysm repair
Scientific Title
Efficacy of emergent cerebrospinal fluid drainage on spinal cord injury after aortic aneurysm repair
Scientific Title:Acronym
Emergent cerebrospinal fluid drainage after aortic aneurysm repair
Region
| Japan |
Condition
Condition
aortic aneurysm
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assess of the potential efficacy of emergent cerebrospinal fluid drainage (eCSFD) as a treatment for unpredicted neurological deficits caused by spinal cord ischemia after aortic aneurysm repair.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the improvement on the paraplegia scale by the time of discharge from the hospital.
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
| 35 | years-old | <= |
Age-upper limit
| 88 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with neurological deficits after the aortic aneurysm repair
Key exclusion criteria
patients who had undergone CSFD before the repair or had paraparesis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Nakazawa |
Organization
Sapporo Medical University of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
Address
Hokkaido prefecture Sapporo City South 1 West 16
TEL
0116112111
bankara02@chic.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junji Nakazawa |
Organization
Sapporo Medical University of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
Address
Hokkaido prefecture Sapporo City South 1 West 16
TEL
0116112111
Homepage URL
bankara02@chic.ocn.ne.jp
Sponsor or person
Institute
Sapporo Medical University of Medicine
Department of Cardiovascular Surgery
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Address
Tel
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
| 2018 | Year | 07 | Month | 30 | 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
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2018 | Year | 07 | Month | 26 | Day |
Last modified on
| 2018 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038229
