UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021978 |
|---|---|
| Receipt number | R000025334 |
| Scientific Title | The evaluation of organ disfunction related with stentgraft placement |
| Date of disclosure of the study information | 2016/04/20 |
| Last modified on | 2017/11/03 23:42:14 |
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Basic information
Public title
The evaluation of organ disfunction related with stentgraft placement
Acronym
The evaluation of organ disfunction related with stentgraft placement
Scientific Title
The evaluation of organ disfunction related with stentgraft placement
Scientific Title:Acronym
The evaluation of organ disfunction related with stentgraft placement
Region
| Japan |
Condition
Condition
aortic disease
Classification by specialty
| Surgery in general | Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study about organ disfunction related with stent graft placement
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival, clinical findings, blood test, image study
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
| 10 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients underwent stentgraft placement
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitsugu Nakamura |
Organization
Chiba-Nishi General Hospital
Division name
The department of cardiovascular surgery
Zip code
Address
107-1, Kanegasaku, Matsudo-shi, Chiba-ken
TEL
047-384-8111
yohei4201@yahoo.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Kawatani |
Organization
Chiba-Nishi General Hospital
Division name
The department of cardiovascular surgery
Zip code
Address
107-1, Kanegasaku, Matsudo-shi, Chiba-ken
TEL
047-384-8111
Homepage URL
yohei4201@yahoo.com
Sponsor or person
Institute
Chiba-Nishi General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2016 | Year | 04 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Correlations of perioperative coagulopathy, fluid infusion and blood transfusions with survival prognosis in endovascular aortic repair for ruptured abdominal aortic aneurysm.
https://wjes.biomedcentral.com/articles/10.1186/s13017-016-0087-0;
Development of Delirium in the Intensive Care Unit in Patients after Endovascular Aortic Repair: A Retrospective Evaluation of the Prevalence and Risk Factors.
https://www.hindawi.com/journals/ccrp/2015/405817/
Contrast Medium Induced Nephropathy after Endovascular Stent Graft Placement: An Examination of Its Prevalence and Risk Factors.
https://www.hindawi.com/journals/rrp/2016/5950986/
Acute pancreatitis caused by pancreatic ischemia after TEVAR combined with intentional celiac artery coverage and embolization of the branches of the celiac artery.
Kawatani Y, Kurobe H, Nakamura Y, Suda Y, Okuma Y, Sato S, Hashimoto T, Hori T.
J Surg Case Rep. 2017 Feb 23;2017(2):rjx029. doi: 10.1093/jscr/rjx029
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
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | 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
None
Management information
Registered date
| 2016 | Year | 04 | Month | 19 | Day |
Last modified on
| 2017 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025334
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
