Continuous Assessment of Brain Blood Perfusion in Subarachnoid Hemorrhage Patients Using Near-Infrared Spectroscopy (NIRS)
NCT ID: NCT06932640
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
120 participants
OBSERVATIONAL
2026-03-31
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
- 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.
Interventions
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- 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
89 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
University of Alabama at Birmingham
OTHER
Responsible Party
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Weifeng Song
Assistant Professor
Principal Investigators
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Weifeng Song, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
The University of Alabama at Birmingham
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pending
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB-300014488
Identifier Type: -
Identifier Source: org_study_id
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