UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015309 |
|---|---|
| Receipt number | R000017805 |
| Scientific Title | Motor Evoked Potential and Cerebrospinal Fluid Drainage in Thoracic and Thoracoabdominal Aneurysm Repair |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2018/12/26 15:10:01 |
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Basic information
Public title
Motor Evoked Potential and Cerebrospinal Fluid Drainage in Thoracic and Thoracoabdominal Aneurysm Repair
Acronym
MEDICAL
Scientific Title
Motor Evoked Potential and Cerebrospinal Fluid Drainage in Thoracic and Thoracoabdominal Aneurysm Repair
Scientific Title:Acronym
MEDICAL
Region
| Japan |
Condition
Condition
Thoracoabdominal aneurysm
Thoracic aneurysm
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Reserch the factor that influence motor Evoked Potential and
effecicacy of cerebrospinal fluid drainage
in Thoracic and Thoracoabdominal Aneurysm Repair
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reserch the factor that influence motor Evoked Potential and
effecicacy of cerebrospinal fluid drainage
in Thoracic and Thoracoabdominal Aneurysm Repair
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients more than 20 years old and will be given thoracic and thoracoabdominal aneurysm repair
Key exclusion criteria
The patietnts do not give the informed consent
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Ohnishi |
Organization
National Cerebral and Cardiovascular center
Division name
Department of Anesthesiology
Zip code
Address
Fujishirodai 5-7-1, Suita, Osaka
TEL
06-6833-5012
yonishi@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Yoshitani |
Organization
National Cerebral and Cardiovascular center
Division name
Department of Anesthesiology
Zip code
Address
Fujishirodai 5-7-1, Suita, Osaka
TEL
06-6833-5012
Homepage URL
ykenji@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shinsyu University,Nagoya university,Nara medical University,Sakakibara memorial hospital,Kokura memorial hospital
Tokyo University,Keio University,Tokyo medical university,Sapporo medical university,Hokkaido University,Tottori university,Ryukyu University,Yamaguchi University,Yokohama city university medical center Shin Tokyo hospital,Fukui circulation hospital,Saitama medical center Jichi medical university, Kobe university, Tokyo Jikei university
Name of secondary funder(s)
none
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
信州大学
名古屋大学
奈良県立医科大学
榊原記念病院
小倉記念病院
東京大学
慶応大学
東京医科大学
札幌医科大学
北海道大学
鳥取大学
琉球大学
山口大学
横浜市立大学附属市民総合医療センター
東京慈恵会医科大学
新東京病院
福井循環器病院
自治医大附属さいたま医療センター
東京慈恵会医大
神戸大学
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 01 | 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
| 2014 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | 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
Observational study
Management information
Registered date
| 2014 | Year | 10 | Month | 01 | Day |
Last modified on
| 2018 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017805
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/11/01 | MEDICAL 研究計画書ver 1.7.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2017/04/07 | 症例報告書 MEDICAL ver1.14.doc |
| Research case data | |
|---|---|
| Registered date | File name |
