UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034214 |
|---|---|
| Receipt number | R000039005 |
| Scientific Title | Proteomics of cerebrospinal fluid after remote ischemic preconditioning |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2020/03/22 14:26:48 |
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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
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
mrsssakai@yahoo.co.jp
Sponsor or person
Institute
Mie university hospital
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
0592315634
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 16 | Day |
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
| 2020 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039005
