UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054415 |
|---|---|
| Receipt number | R000061849 |
| Scientific Title | Japan Comprehensive Process for End-of-Life Care and Organ Donation After Brain Death |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/11/17 08:53:21 |
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Basic information
Public title
Japan Comprehensive Process for End-of-Life Care and Organ Donation After Brain Death
Acronym
Japan Comprehensive Process for End-of-Life Care and Organ Donation After Brain Death
Scientific Title
Japan Comprehensive Process for End-of-Life Care and Organ Donation After Brain Death
Scientific Title:Acronym
J-RESPECT study
Region
| Japan |
Condition
Condition
Brain death
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To provide a detailed overview and examination of the organ donation process in active institutions, focusing on understanding current practices to facilitate improvements in Japan's organ donation procedures, management, and systems.
Basic objectives2
Others
Basic objectives -Others
To examine the consent processes for legal brain death diagnosis and organ donation after brain death among Japanese institutions that have actively facilitated actual organ donations
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of organ donations after brain death
Key secondary outcomes
1. Time intervals from admission to the diagnosis of brain death, option presentation of organ donation to the family, and organ procurement
2. Time intervals from admission to the start of administration of antidiuretic hormone and steroids
3. The number of multidisciplinary team meetings
4. Characteristics of institutions that are active in organ donation after brain death
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
Patients involved in organ donation after brain death
Key exclusion criteria
1. Patients whose families or representatives refuse to participate in the study.
2. Based upon each institution's decision, patients whose families or representatives refuse to disclose information on the webpage of the Japan Organ Transplant Network
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Atsunori |
| Middle name | |
| Last name | Nakao |
Organization
Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Division name
Department of Emergency, Critical Care and Disaster Medicine
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7426
qq-nakao@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Yumoto |
Organization
Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Division name
Department of Emergency, Critical Care and Disaster Medicine
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7426
Homepage URL
tyumoto@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Okayama University Hospital Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
086-235-6938
mae6605@adm.okayama-u.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
| 2024 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
NA
Publication of results
Partially published
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
204
Results
A total of 204 brain-dead donors (21.8% of all cases nationwide) were included, with 96 from 5 extremely active institutions and 108 from 11 highly active institutions.
Results date posted
| 2025 | Year | 11 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We included all brain-dead organ donors who had at least one organ procured and transplanted between July 17, 2010, and December 31, 2023.
Participant flow
All 204 eligible cases were registered and included in the analysis.
Adverse events
None.
Outcome measures
To analyze differences in organ donation practices among institutions with varying levels of donation activity, we categorized the 16 participating institutions into 2 groups based on the number of brain-dead organ donations performed during the study period. A threshold of 14 or more donations was used for the highly active group, while 13 or fewer donations defined as the moderately active group, ensuring a balanced case distribution between the 2 groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
The following data or information will be retrieved: signs of brain death, specialized management due to the physiological changes associated with brain death, multidisciplinary discussions on end-of-life care, and institutional organ donation systems.
Management information
Registered date
| 2024 | Year | 05 | Month | 16 | Day |
Last modified on
| 2025 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061849
