UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032782 |
|---|---|
| Receipt number | R000037361 |
| Scientific Title | Epidemiological study on anesthesia management and circulation management in TAVI (Transcatheter Aortic Valve Implantation) |
| Date of disclosure of the study information | 2018/06/18 |
| Last modified on | 2019/05/31 19:42:55 |
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Basic information
Public title
Epidemiological study on anesthesia management and circulation management in TAVI (Transcatheter Aortic Valve Implantation)
Acronym
Epidemiological study on anesthesia management and circulation management in TAVI
Scientific Title
Epidemiological study on anesthesia management and circulation management in TAVI (Transcatheter Aortic Valve Implantation)
Scientific Title:Acronym
Epidemiological study on anesthesia management and circulation management in TAVI
Region
| Japan |
Condition
Condition
Aortic valve stenosis
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to investigate and examine TAVI patients background, type of operation, perioperative cardiac function, circulation condition in the operation, perioperative complication, prognosis.
Basic objectives2
Others
Basic objectives -Others
It is anticipated that TAVI is applied not only to aortic valve stenosis but also to elderly patients and other serious complications in many cases. The importance of anesthesia management and circulation management during the TAVI operation is unclear.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post operative delirium
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
AS patients
Key exclusion criteria
No
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Wagatsuma |
Organization
Tohoku University
Division name
Department of Anesthesiology and Intensive Care
Zip code
9813205
Address
1-1, Seiryo-Machi, Aoba-ku, Sendai-shi, Miyagi-ken, Japan
TEL
0227177321
t-waga@umin.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiro |
| Middle name | |
| Last name | Wagatsuma |
Organization
Tohoku University
Division name
Department of Anesthesiology and Intensive Care
Zip code
9813205
Address
1-1, Seiryo-Machi, Aoba-ku, Sendai-shi, Miyagi-ken, Japan
TEL
0227177321
Homepage URL
t-waga@umin.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Self founding
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
Tohoku University
Address
1-1, Seiryo-Machi, Aoba-ku, Sendai-shi, Miyagi-ken, Japan
Tel
022-728-4105
http://www.nrs.hosp.tohoku.ac.jp
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 | 06 | Month | 18 | 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
80
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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preinitiation
Management information
Registered date
| 2018 | Year | 05 | Month | 30 | Day |
Last modified on
| 2019 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037361
