Tokyo, Nov. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063358) titled 'Monitoring strategies and Outcomes: Systematic Assessment in Intensive Care for SAH' on Nov. 2.

Study Type: Observational

Primary Sponsor: Institute - Japan Community Healthcare Organization Chukyo Hospital

Condition: Condition - Aneurysmal subarachnoid hemorrhage Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To estimate the adjusted exploratory association between prespecified monitoring configuration categories based on patient-specific plans active at the start of Day 4 after aneurysmal subarachnoid hemorrhage and favorable functional outcome (modified Rankin Scale [mRS] 0-2) at 90 days after onset. The day of onset is Day 0. Categories are fixed at the start of Day 4 and are not reclassified according to subsequent monitoring performance, additions, discontinuation, or outcomes. Secondary objectives are to describe the ordinal distribution of 90-day mRS, discharge mRS, symptomatic cerebral vasospasm, and delayed cerebral ischemia (DCI)-related cerebral infarction. Thirteen facility-level monitoring policies are described individually without an unvalidated sum score. This observational study does not establish device-specific efficacy, safety, reduction in complications, or the minimum necessary monitoring intensity. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients meeting all of the following: (1) subarachnoid hemorrhage caused by a ruptured intracranial aneurysm; (2) definitive treatment by open surgery or an endovascular procedure; (3) postoperative perioperative management for DCI and cerebral vasospasm, regardless of the use or type of prophylactic medication; (4) age 18 years or older; and (5) admission between April 1, 2023 and March 31, 2026. Key exclusion criteria - Traumatic subarachnoid hemorrhage; nonaneurysmal subarachnoid hemorrhage; death before the start of Day 4 precluding classification of presymptomatic monitoring intensity; or refusal to participate through the opt-out procedure. Patients who meet the registration criteria but are ineligible for the Day 4 landmark analysis or have unverifiable timing remain registered and are not replaced by other cases. Target Size - 400

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 24 Day Anticipated trial start date - 2026 Year 11 Month 02 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=R000072508

Disclaimer: Curated by HT Syndication.