UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000040790