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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007554
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Juntedo University
Cardiovascular surgery
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008924

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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