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

ConditionSubarachnoid Hemorrhage, Aneurysmal
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorUniversity of Alabama at Birmingham

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Patients under 18 years old

Prisoners

Pregnant women

Patients enrolled in concurrent ongoing interventional trial

Trial population

Neurological Intensive Care Unit (NICU) patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • - 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.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Aneurysmal subarachnoid hemorrhage (SAH) patients1 intervention

Trial outcomes

Primary outcomes

1

Change in Lower Limit of Autoregulation (LLA)

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

Time frame
21 days

Secondary outcomes

1

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

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

Time frame
21 days
2

Change in time under LLA

Correlation in time under LLA

Time frame
21 days
3

Change in dose under LLA

Correlation in dose under LLA

Time frame
21 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Edwards Lifesciences

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: