UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026536 |
|---|---|
| Receipt number | R000030475 |
| Scientific Title | An observation of the association between anesthetic management and early postoperative outcomes in patients undergoing myoblast sheet transplantation |
| Date of disclosure of the study information | 2017/03/16 |
| Last modified on | 2023/03/22 16:40:20 |
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Basic information
Public title
An observation of the association between anesthetic management and early postoperative outcomes in patients undergoing myoblast sheet transplantation
Acronym
Anesthetic management of myoblast sheet transplantation
Scientific Title
An observation of the association between anesthetic management and early postoperative outcomes in patients undergoing myoblast sheet transplantation
Scientific Title:Acronym
Anesthetic management of myoblast sheet transplantation
Region
| Japan |
Condition
Condition
cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal how the anesthetic management influences early postoperative outcomes in patients undergoing myoblast sheet transplantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The length of mechanical ventilation and intensive care unit stay
Key secondary outcomes
Postoperative pain intensity and analgesic requirements
intraoperative and postoperative complications
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
Adult patients undergoing myoblast sheet transplantion
Key exclusion criteria
Patients who does not agree or understand the aim of the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenta Okitsu |
Organization
Osaka university graduate school of medicine
Division name
Department of anesthesiology and intensive care medicine
Zip code
Address
Yamadaoka2-2, Suita, Osaka, Japan
TEL
06-6879-3133
kokitsu@anes.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenta Okitsu |
Organization
Osaka university graduate school of medicine
Division name
Department of anesthesiology and intensive care medicine
Zip code
Address
Yamadaoka2-2, Suita, Osaka, Japan
TEL
06-6879-3133
Homepage URL
kokitsu@anes.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2017 | Year | 03 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We prospectively register patients' background, perioperative medication, the details of anesthetic management, intra- and postoperative complications, pain intensity and early postoperative recovery. Then we make analysis to seek how we can improve anesthetic management in patients undergoing myoblast sheet transplantation.
Management information
Registered date
| 2017 | Year | 03 | Month | 13 | Day |
Last modified on
| 2023 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030475
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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