Continuous Assessment of Brain Blood Perfusion in Subarachnoid Hemorrhage Patients Using Near-Infrared Spectroscopy (NIRS)

Not yet recruiting

• Conditions: Subarachnoid Hemorrhage, Aneurysmal

• Registration Number: NCT06932640
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The goal of this observational study is to continuously assess cerebral autoregulation in patients with subarachnoid hemorrhage (SAH) using cerebral oximetry index (COx) and hemoglobin volume reactivity index (HVx). The main question it aims to answer is: Whether optimal perfusion pressure is dynamic and changes with time in patients with SAH, and that autoregulation is disrupted in patients during the course of SAH, contributing to delayed cerebral ischemia (DCI).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17
• Study Start: 2025-06
• Primary Completion: 2027-03
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients aged 18 to 89 years who are admitted to the Neurological Intensive Care Unit (Neuro ICU) between March 2025 and December 2026 for aneurysmal subarachnoid hemorrhage (SAH).

Exclusion Criteria

• Patients under 18 years old
• Prisoners
• Pregnant women
• Patients enrolled in concurrent ongoing interventional trial
• Students of UAB
• Employees of UAB
• Patients who undergoes frontal decompression surgery resulting bone flap deficit where NIRS monitoring pads could not be applied.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Lower Limit of Autoregulation (LLA)	21 days	Successful calculations of moving Lower Limit of Autoregulation (LLA) for all three algorithms

Secondary Outcome Measures

Name	Time	Method
Change of delayed cerebral ischemia (DCI) to the average LLA	21 days	Correlation of clinical course of delayed cerebral ischemia (DCI) to average LLA
Change in time under LLA	21 days	Correlation in time under LLA
Change in dose under LLA	21 days	Correlation in dose under LLA

Trial Locations

Locations (1)

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States