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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033525
Receipt No. R000038229
Scientific Title Efficacy of emergent cerebrospinal fluid drainage on spinal cord injury after aortic aneurysm repair
Date of disclosure of the study information 2018/07/30
Last modified on 2018/07/26

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Basic information
Public title Efficacy of emergent cerebrospinal fluid drainage on spinal cord injury after aortic aneurysm repair
Acronym Emergent cerebrospinal fluid drainage after aortic aneurysm repair
Scientific Title Efficacy of emergent cerebrospinal fluid drainage on spinal cord injury after aortic aneurysm repair
Scientific Title:Acronym Emergent cerebrospinal fluid drainage after aortic aneurysm repair
Region
Japan

Condition
Condition aortic aneurysm
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We assess of the potential efficacy of emergent cerebrospinal fluid drainage (eCSFD) as a treatment for unpredicted neurological deficits caused by spinal cord ischemia after aortic aneurysm repair.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome is the improvement on the paraplegia scale by the time of discharge from the hospital.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
35 years-old <=
Age-upper limit
88 years-old >
Gender Male and Female
Key inclusion criteria patients with neurological deficits after the aortic aneurysm repair
Key exclusion criteria patients who had undergone CSFD before the repair or had paraparesis
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junji Nakazawa
Organization Sapporo Medical University of Medicine
Division name Department of Cardiovascular Surgery
Zip code
Address Hokkaido prefecture Sapporo City South 1 West 16
TEL 0116112111
Email bankara02@chic.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junji Nakazawa
Organization Sapporo Medical University of Medicine
Division name Department of Cardiovascular Surgery
Zip code
Address Hokkaido prefecture Sapporo City South 1 West 16
TEL 0116112111
Homepage URL
Email bankara02@chic.ocn.ne.jp

Sponsor
Institute Sapporo Medical University of Medicine
Department of Cardiovascular Surgery
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 07 Month 30 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 03 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 04 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 nothing

Management information
Registered date
2018 Year 07 Month 26 Day
Last modified on
2018 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038229

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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