Subarachnoid Hemorrhage, AneurysmalNCT06932640
Continuous Assessment of Brain Blood Perfusion in Subarachnoid Hemorrhage Patients Using Near-Infrared Spectroscopy (NIRS)
An observational study of Subarachnoid Hemorrhage, Aneurysmal, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- - Non-Invasive Near-infrared Spectroscopy (NIRS) device (HEM1 with Foresight Elite Sensor)
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Neurological Intensive Care Unit (NICU) patients
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Weifeng Song, M.D., Ph.D, 205-934-4699, wsong@uabmc.edu
Weifeng Song, M.D., Ph.D
About this study
Official title: Continuous Assessment of Cerebral Autoregulation in Subarachnoid Hemorrhage (SAH) Patients Using Cerebral Oximetry Index and Hemoglobin Volume Reactivity Index
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).
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Being tested
- - Non-Invasive Near-infrared Spectroscopy (NIRS) device (HEM1 with Foresight Elite Sensor)
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Aneurysmal subarachnoid hemorrhage (SAH) patients | The study will be conducted on patients aged 18 to 89 years admitted to the Neurological Intensive Care Unit (ICU) with a Aneurysmal subarachnoid hemorrhage (SAH). The study will use near-infrared spectroscopy (NIRS) monitors (which is outside standard of care) and transcranial doppler (TCD, only when available and is standard of care) that will be attached to these patients. The data from these devices will be used solely for analysis after the patients have been discharged. Receives: Device: - Non-Invasive Near-infrared Spectroscopy (NIRS) device (HEM1 with Foresight Elite Sensor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lower Limit of Autoregulation (LLA)
Successful calculations of moving Lower Limit of Autoregulation (LLA) for all three algorithms
Measured: 21 days
Secondary outcomes (3)
Change of delayed cerebral ischemia (DCI) to the average LLA
Correlation of clinical course of delayed cerebral ischemia (DCI) to average LLA
Measured: 21 days
Change in time under LLA
Correlation in time under LLA
Measured: 21 days
Change in dose under LLA
Correlation in dose under LLA
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start30 Nov 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, Weifeng Song, University of Alabama at Birmingham
- Investigators
- Weifeng Song, M.D., Ph.D, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932640
- Sponsor's protocol ID
- IRB-300014488
- Other IDs
- HCP-135292794
- Status last verified
- Oct 2026
- First submitted
- 10 Apr 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided