UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030122 |
|---|---|
| Receipt number | R000033883 |
| Scientific Title | Survey on Circulatory Management for Japanese Heart Donors |
| Date of disclosure of the study information | 2018/01/30 |
| Last modified on | 2020/06/01 13:06:03 |
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Basic information
Public title
Survey on Circulatory Management for Japanese Heart Donors
Acronym
Ciruculatory Management for Heart Donors
Scientific Title
Survey on Circulatory Management for Japanese Heart Donors
Scientific Title:Acronym
Ciruculatory Management for Heart Donors
Region
| Japan |
Condition
Condition
Heart transplantation donor
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To survey on the current circulatory management of heart donors in Japan, and to elucidate the appropriate management
Basic objectives2
Others
Basic objectives -Others
To survay on real-world data
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival of the heart transplantation recipients
Key secondary outcomes
Cardiovascular events, including low output syndrome, necessity of circulatory support, development of coronary lesion, and rejection, in heart transplantation recipients
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All donors for the heart transplantations performed in the participating institutions involved in this research project
Key exclusion criteria
None
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Yoshikatsu |
| Middle name | |
| Last name | Saiki |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Cardiovascular Surgery
Zip code
980-8574
Address
1-1 Seiryocho, Aoba-ku, Sendai, Miyagi
TEL
+81-22-717-7222
yoshisaiki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Takahara |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Cardiovascular Surgery
Zip code
980-8574
Address
1-1 Seiryocho, Aoba-ku, Sendai, Miyagi
TEL
+81-22-717-7222
Homepage URL
takahara@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research, Innovation and Education Center, Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-717-7122
office@crieto.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
東京大学病院(東京都)、大阪大学(大阪府)、国立循環器病研究センター(大阪府)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not yet
Management information
Registered date
| 2017 | Year | 11 | Month | 26 | Day |
Last modified on
| 2020 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033883
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
