UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059018 |
|---|---|
| Receipt number | R000067497 |
| Scientific Title | J-RESPECT2 study: Japan CompREhenSive Process for End-of-Life Care and Organ DonaTion after Brain Death |
| Date of disclosure of the study information | 2025/09/15 |
| Last modified on | 2025/09/06 12:13:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
J-RESPECT2 study: Japan CompREhenSive Process for End-of-Life Care and Organ DonaTion after Brain Death
Acronym
J-RESPECT2 study
Scientific Title
J-RESPECT2 study: Japan CompREhenSive Process for End-of-Life Care and Organ DonaTion after Brain Death
Scientific Title:Acronym
J-RESPECT2 study
Region
| Japan |
Condition
Condition
Acute brain injuries such as post-cardiac arrest syndrome, severe traumatic brain injury, and severe stroke
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Real-world data on care pathways leading to organ donation in Japan remain limited. The process of end-of-life care following catastrophic brain injury, including how and when donation is considered, and how patients are managed, has not been comprehensively described. In this multicenter prospective study, we aimed to examine the trajectory of end-of-life care, including the organ donation process, among patients with devastating brain injuries considered possible donors.
Basic objectives2
Others
Basic objectives -Others
To clarify the factors and processes by which patients who are medically eligible for organ donation after brain death proceed to actual organ donation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Organ donation after brain death
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients admitted to the ICU between the date of approval by the head of the research institution and December 31, 2027, after emergency department presentation or emergency transport, with severe brain injury, receiving mechanical ventilation, and presenting, except immediately prior to death confirmation, with deep coma (Glasgow Coma Scale score of 3) and bilateral fixed dilated pupils (4 mm or greater), in a state judged not to be influenced by sedatives or other medications.
2. Male and female patients of all ages.
3. Including those transferred from other hospitals.
Key exclusion criteria
1. Patients transferred from a referring hospital more than 24 hours after the initial visit or transport to that hospital.
2. Patients transferred from a general ward, admitted to the ICU for the first time during that hospitalization.
3. Patients in which no key family member is available.
4. Patients deemed inappropriate by the attending physician.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 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
tyumoto@cc.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
Japanese Association for Acute Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine Dentistry and Pharmacentical Sciences and Olayama University Hosoital 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
| 2025 | Year | 09 | Month | 15 | 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
| 2025 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Facility Information
2) Process up to Case Registration and Patient Information
3) Information on Healthcare Providers
Management information
Registered date
| 2025 | Year | 09 | Month | 06 | Day |
Last modified on
| 2025 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067497
