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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032782
Receipt No. 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

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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
Email 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
Email t-waga@umin.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037361

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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