UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035805 |
|---|---|
| Receipt number | R000040790 |
| Scientific Title | Proteomics analysis of cerebrospinal fluid for screening of POCD-associated molecules |
| Date of disclosure of the study information | 2019/02/07 |
| Last modified on | 2019/08/09 10:09:19 |
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Basic information
Public title
Proteomics analysis of cerebrospinal fluid for screening of POCD-associated molecules
Acronym
Proteomics of cerebrospinal fluid
Scientific Title
Proteomics analysis of cerebrospinal fluid for screening of POCD-associated molecules
Scientific Title:Acronym
Proteomics of cerebrospinal fluid
Region
| Japan |
Condition
Condition
Thoracic aortic aneurysm
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Screening of POCD-associated molecules from crebrospinal fluid
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Detection of fluctuation of cerebrospinal fluid proteins (Pre, 1hr after and 24 hr after of general anesthesia)
Key secondary outcomes
frequency of post operative cognitive disorder
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Insertion of cerebrospinal drainage catheter
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Thoracic endovascular aortic repair
Key exclusion criteria
Change of operation precedure from endvascular surgery to open surgery)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | Kamei |
Organization
Mie University Hospital
Division name
Clinical anesthesia
Zip code
514-8507
Address
Edobashi 2-174, Tsu, Mie
TEL
+81-59-231-5634
kamei@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nakamori |
Organization
Mie University Hospital
Division name
Clinical anesthesia
Zip code
514-8507
Address
Edobashi 2-174, Tsu, Mie
TEL
+81-59-231-5634
Homepage URL
mrsssakai@yahoo.co.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie University Hospital Research Support Center
Address
Edobashi 2-174 Tsu, Mie
Tel
+81-59-232-1111
s-kenkyu@mo.medic.mie-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
| 2019 | Year | 02 | Month | 07 | 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
| 2019 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 07 | Day |
Last modified on
| 2019 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040790
