Tokyo, Sept. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059018) titled 'J-RESPECT2 study: Japan CompREhenSive Process for End-of-Life Care and Organ DonaTion after Brain Death' on Sept. 15.

Study Type: Observational

Primary Sponsor: Institute - Okayama University

Condition: Condition - Acute brain injuries such as post-cardiac arrest syndrome, severe traumatic brain injury, and severe stroke Classification by malignancy - Others Genomic information - NO

Objective: 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

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 Size - 1000

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 05 Day Anticipated trial start date - 2026 Year 01 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067497

Disclaimer: Curated by HT Syndication.