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

Continuous Assessment of Cerebral Autoregulation in Subarachnoid Hemorrhage (SAH) Patients Using Cerebral Oximetry Index and Hemoglobin Volume Reactivity Index

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06932640
Enrollment
120
Registered
2025-04-17
Start date
2026-08-03
Completion date
2028-12-01
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid Hemorrhage, Aneurysmal

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).

Interventions

DEVICE- Non-Invasive Near-infrared Spectroscopy (NIRS) device (HEM1 with Foresight Elite Sensor)

Near-Infrared Spectroscopy (NIRS) monitors, provided by Edwards Lifesciences, is a monitoring technique. It will be connected to consented patients, automatically capturing brain oxygen as waveform output, and stored in Sickbay system. The NIRS is a non-invasive monitoring method, in which adhesive pads will be applied to forehead. 4 hours continuous monitoring will be recorded on day 1 after SAH (or on presence to NICU), then every three days from day 3 to day 14 (within the DCI window), to 1 to 2 recordings from day 15 to day 21.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER
Edwards Lifesciences
CollaboratorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Lower Limit of Autoregulation (LLA)21 daysSuccessful calculations of moving Lower Limit of Autoregulation (LLA) for all three algorithms

Secondary

MeasureTime frameDescription
Change of delayed cerebral ischemia (DCI) to the average LLA21 daysCorrelation of clinical course of delayed cerebral ischemia (DCI) to average LLA
Change in time under LLA21 daysCorrelation in time under LLA
Change in dose under LLA21 daysCorrelation in dose under LLA

Countries

United States

Contacts

CONTACTRoxana Santander-Chapeta
rsantanderchapeta@uabmc.edu205-975-2846
CONTACTLaShun L. Horn, M.S.
llhorn@uabmc.edu205-996-2606
PRINCIPAL_INVESTIGATORWeifeng Song, M.D., Ph.D

The University of Alabama at Birmingham

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026