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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035805
Receipt No. 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

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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
Email 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
Email mrsssakai@yahoo.co.jp

Sponsor
Institute Mie University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040790

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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