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

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 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

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

Value
https://center6.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