[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06932640":3,"trial-entities:NCT06932640":97,"trial-summary:NCT06932640":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":17,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":33,"secondary_outcomes":38,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":63,"locations":66,"central_contacts":84,"overall_officials":93,"references":95,"see_also_links":96},"NCT06932640","IRB-300014488","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","NOT_YET_RECRUITING","2028-12","2026-07","2026-07-14","2026-08-03","University of Alabama at Birmingham","OTHER",false,"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).",null,[19],"Subarachnoid Hemorrhage, Aneurysmal",[],"OBSERVATIONAL",[],{"count":24,"type":25},120,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"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.",[32],"Aneurysmal subarachnoid hemorrhage (SAH) patients",[34],{"measure":35,"description":36,"timeFrame":37},"Change in Lower Limit of Autoregulation (LLA)","Successful calculations of moving Lower Limit of Autoregulation (LLA) for all three algorithms","21 days",[39,42,45],{"measure":40,"description":41,"timeFrame":37},"Change of delayed cerebral ischemia (DCI) to the average LLA","Correlation of clinical course of delayed cerebral ischemia (DCI) to average LLA",{"measure":43,"description":44,"timeFrame":37},"Change in time under LLA","Correlation in time under LLA",{"measure":46,"description":47,"timeFrame":37},"Change in dose under LLA","Correlation in dose under LLA","ALL","18 Years","89 Years",{"inclusion":52,"exclusion":54,"raw_text":62},[53],"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).",[55,56,57,58,59,60,61],"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.","Inclusion Criteria:\n\n* 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).\n\nExclusion Criteria:\n\n* Patients under 18 years old\n* Prisoners\n* Pregnant women\n* Patients enrolled in concurrent ongoing interventional trial\n* Students of UAB\n* Employees of UAB\n* Patients who undergoes frontal decompression surgery resulting bone flap deficit where NIRS monitoring pads could not be applied.",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":68,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":81},"The University of Alabama at Birmingham","Birmingham","Alabama","35294","United States",[74,79],{"name":75,"role":76,"phone":77,"email":78},"Weifeng Song, M.D., Ph.D","CONTACT","205-934-4699","wsong@uabmc.edu",{"name":75,"role":80},"PRINCIPAL_INVESTIGATOR",{"lat":82,"lon":83},33.52066,-86.80249,[85,89],{"name":86,"role":76,"phone":87,"email":88},"Roxana Santander-Chapeta","205-975-2846","rsantanderchapeta@uabmc.edu",{"name":90,"role":76,"phone":91,"email":92},"LaShun L. Horn, M.S.","205-996-2606","llhorn@uabmc.edu",[94],{"name":75,"affiliation":68,"role":80},[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[99],"Subarachnoid Hemorrhage",[],{"nct_id":4,"found":102,"summary":103,"prompt_version":113},true,{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an observational study involving 120 participants. It is not testing a new treatment but rather observing how the brain's blood flow regulation changes in patients with subarachnoid hemorrhage.","completed","Observational Study of Brain Blood Flow in Subarachnoid Hemorrhage","This observational study aims to understand how blood flow to the brain changes in patients who have experienced a subarachnoid hemorrhage (SAH), which is bleeding on the surface of the brain. Researchers will use a non-invasive device called Near-Infrared Spectroscopy (NIRS) (HEM1 with Foresight Elite Sensor) to continuously monitor brain oxygen levels. The main goal is to see if the ideal blood pressure for the brain changes over time in SAH patients, and if problems with the brain's ability to regulate its own blood flow contribute to delayed brain injury. This study is for patients aged 18 to 89 who are admitted to the Neuro ICU for aneurysmal SAH between March 2025 and December 2026. The study will measure changes in the Lower Limit of Autoregulation (LLA) over 21 days.","The primary endpoint is measured at 21 days, indicating monitoring for at least that duration.",130,"You would have a non-invasive NIRS device connected, which automatically captures brain oxygen data and stores it. The study will measure changes over 21 days.","Not stated in the trial record.",[],"v2"]