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NCT Number: NCT06932640

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

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).

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Key information

Conditions

Subarachnoid Hemorrhage, Aneurysmal Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location contact

Weifeng Song, M.D., Ph.D

CONTACT

[email protected]

205-934-4699

Weifeng Song, M.D., Ph.D

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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.

Primary outcomes

  1. Change in Lower Limit of Autoregulation (LLA)

    Time frame: 21 days

    Successful calculations of moving Lower Limit of Autoregulation (LLA) for all three algorithms

Secondary outcomes

  1. Change of delayed cerebral ischemia (DCI) to the average LLA

    Time frame: 21 days

    Correlation of clinical course of delayed cerebral ischemia (DCI) to average LLA

  2. Change in time under LLA

    Time frame: 21 days

    Correlation in time under LLA

  3. Change in dose under LLA

    Time frame: 21 days

    Correlation in dose under LLA

Study contacts

Contact information is provided by the study sponsor or research team.

LaShun L. Horn, M.S.

CONTACT

[email protected]

205-996-2606

Roxana Santander-Chapeta

CONTACT

[email protected]

205-975-2846

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Edwards Lifesciences

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 17, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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