UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046836 |
|---|---|
| Receipt number | R000053437 |
| Scientific Title | A retrospective observational study to evaluate the efficacy of terminal warm blood cardioplegia with the microplegia method in cardiac surgery. |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2025/02/21 08:40:30 |
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Basic information
Public title
A retrospective observational study to evaluate the efficacy of terminal warm blood cardioplegia with the microplegia method in cardiac surgery.
Acronym
A retrospective observational study to evaluate the efficacy of terminal warm blood cardioplegia with the microplegia method in cardiac surgery.
Scientific Title
A retrospective observational study to evaluate the efficacy of terminal warm blood cardioplegia with the microplegia method in cardiac surgery.
Scientific Title:Acronym
A retrospective observational study to evaluate the efficacy of terminal warm blood cardioplegia with the microplegia method in cardiac surgery.
Region
| Japan |
Condition
Condition
cardiac surgery
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of whether terminal warm blood cardioplegia is safe and effective in the microplegia cardioplegia method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of Ventricular Arrhythmia After declamping.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
cardiac surgery with cardiac arrest
Key exclusion criteria
cardioplegic method is not microplegia
underage
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kunihara |
Organization
The Jikei university school of medicine
Division name
Cardiac surgery
Zip code
105-8471
Address
3-25-8, nishi-shimbashi, mitnato-ku, Tokyo
TEL
0334331111
kuniharat@gmail.com
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Abe |
Organization
The Jikei university school of medicine
Division name
Cardiac surgery
Zip code
105-8471
Address
3-25-8, nishi-shimbashi, mitnato-ku, Tokyo
TEL
0334331111
Homepage URL
t-abe@jikei.ac.jp
Sponsor or person
Institute
The Jikei university school of medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei university school of medicine
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
The Jikei university school of medicine
Address
3-25-8, nishi-shimbashi, mitnato-ku, Tokyo
Tel
0334331111
t-abe@jikei.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
| 2022 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2022 | Year | 02 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053437
