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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034214
Receipt No. R000039005
Scientific Title Proteomics of cerebrospinal fluid after remote ischemic preconditioning
Date of disclosure of the study information 2018/10/01
Last modified on 2019/08/09

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Basic information
Public title Proteomics of cerebrospinal fluid after remote ischemic preconditioning
Acronym Proteomics of CSF after RIPC
Scientific Title Proteomics of cerebrospinal fluid after remote ischemic preconditioning
Scientific Title:Acronym Proteomics of CSF after RIPC
Region
Japan

Condition
Condition aneurysm of the thoracic aorta
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Proteomics analysis of ischemic preconditioning using cerebrospinal fluid
Basic objectives2 Others
Basic objectives -Others analysis of molecular mechanisms of ischemic preconditioning
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proteomics of cerebrospinal fluid after remoto ischemic preconditioning (1 hr and 24 hr)
Key secondary outcomes

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 Tourniquet of an upper limb
250 nnHg for 5 min, 3 times
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 Stent graft for aneurysm of thoracic aorta
Key exclusion criteria Emergency
Unsuccessful of spinal drainage catheter
Disease of uppor limbs
HD
Permanent pacemaker
Under mechanical ventilation
Instability of circuratory conditions
Obesity
Pregnancy
Close to death
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Michihiro
Middle name
Last name Sakai
Organization Mie university hospital
Division name Clinical anesthesia
Zip code 514-8507
Address Edobashi 2-174, Tsu, Mie
TEL 059-231-5634
Email mrsssakai@yahoo.co.jp

Public contact
Name of contact person
1st name Michihiro
Middle name
Last name Sakai
Organization Mie university hospital
Division name Clinical anesthesia
Zip code 514-8507
Address Edobashi 2-174, Tsu, Mie
TEL 059-231-5634
Homepage URL
Email mrsssakai@yahoo.co.jp

Sponsor
Institute Mie university hospital
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 0592315634
Email kk-sien@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
2018 Year 10 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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 10 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

Management information
Registered date
2018 Year 09 Month 20 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=R000039005

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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