UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007554 |
|---|---|
| Receipt number | R000008924 |
| Scientific Title | Comparison of endotoxemia after surgery in the laparotomy and in the stent graft to an abdominal aneurysm. |
| Date of disclosure of the study information | 2012/03/23 |
| Last modified on | 2012/03/23 01:35:34 |
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Basic information
Public title
Comparison of endotoxemia after surgery in the laparotomy and in the stent graft to an abdominal aneurysm.
Acronym
Comparison of endotoxemia after surgery in the laparotomy and in the stent graft to an abdominal aneurysm.
Scientific Title
Comparison of endotoxemia after surgery in the laparotomy and in the stent graft to an abdominal aneurysm.
Scientific Title:Acronym
Comparison of endotoxemia after surgery in the laparotomy and in the stent graft to an abdominal aneurysm.
Region
| Japan |
Condition
Condition
abdominal aneurysm
Classification by specialty
| Surgery in general | Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
If control of endotoxemia after stent graft is proved by this our research, it will be thought that the adaptation range of future stent graft may extend further.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
It is verified what an operation way type, time, and a patient background have influence of the quantity of toxin.
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
It is targeted at all the patients who have medical treatment surgically enforced to an aortic aneurysm.
Key exclusion criteria
The example of complications with other operations, such as open heart surgery, is excepted.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | atsumi oishi |
Organization
Juntedo University
Division name
Cardiovascular surgery
Zip code
Address
tokyo bunkyoku hongo3-1-2
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntedo University
Division name
Cardiovascular surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Juntedo University
Cardiovascular surgery
Institute
Department
Personal name
Funding Source
Organization
Juntedo University
Cardiovascular surgery
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 03 | Month | 23 | 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
| 2012 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | 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
Endotoxemia is measured in the case of the blood collecting at the time of after-operation ICU entrance after surgery of an aortic aneurysm.
It is verified what an operation way type, time, and a patient background have influence of the quantity of endotoxemia.
Management information
Registered date
| 2012 | Year | 03 | Month | 23 | Day |
Last modified on
| 2012 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008924
| Research Plan | |
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| Registered date | File name |
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