UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002633 |
|---|---|
| Receipt number | R000003153 |
| Scientific Title | Japanese study of spinal cord protection in descending and thoracoabdominal aortic repair |
| Date of disclosure of the study information | 2009/10/20 |
| Last modified on | 2010/04/16 11:34:56 |
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Basic information
Public title
Japanese study of spinal cord protection in descending and thoracoabdominal aortic repair
Acronym
JASPAR
Scientific Title
Japanese study of spinal cord protection in descending and thoracoabdominal aortic repair
Scientific Title:Acronym
JASPAR
Region
| Japan |
Condition
Condition
Patients who underwent open repair or stent grafting of the descending or thoracoabdominal aortic aorta.
Classification by specialty
| Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In open repair or stent grafting of the descending or thoracoabdominal aortic aorta, we review some impacts of preoperative demonstration of the Adamkiewicz artery by MRI or CT on prevention of spinal cord injury. In addition, some risk factors for spinal cord injury would be demonstrated.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of spinal cord injury prior to the hospital discharge.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who underwent open repair or stent grafting of the descending or thoracoabdominal aortic aorta.
2.Patients who underwent the above procedure between Jan. 2000 and Dec. 2010.
3.In the prospective case enrollment, patients who can give informed consent and sign themselves.
Key exclusion criteria
None
Target sample size
2750
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Ogino |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Surgery
Zip code
Address
5-7-1 Fujishiro-dai, Suita, Osaka, Japan
TEL
06-6833-5012
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Ogino |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Surgery
Zip code
Address
TEL
Homepage URL
hogino@hsp.ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Japanese Ministry of Health, Labor,and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 10 | Month | 20 | 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
| 2009 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Background, Operational information, Complication, CT, Adamkiewicz artery,MRI
Management information
Registered date
| 2009 | Year | 10 | Month | 16 | Day |
Last modified on
| 2010 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003153
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
