BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
Key facts
- Who runs it
- Scienceforbrain, UAB
- Where
- Chicago, United StatesSee the siteAlso in 3 other countries, 3 sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 304 people, planned
- Started
- 30 Sept 2026
- Expected to end
- 30 Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- BrainProtect System
- Standard perioperative management
- Record updated
- 14 October 2026
Who can take part
- Age
- 18 years to 69 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Age 18-69 years
- Patient has provided written informed consent to participate in the study
- Qualification for the elective coronary artery bypass graft (CABG) surgery requiring CPB
Who cannot take part
- Patients with cognitive impairments which could be associated with POD were diagnosed prior to surgery
- Patients who are receiving psychotropic medications
- Patients with an eye disease that may affect monitoring results, as determined by the Investigator
- Patients who have acute or chronic but currently exacerbated respiratory disease
- Patients with uncompensated cardiovascular diseases (II-III AV block or cardiogenic shock)
- Patients with a history of clinically significant neurological or cognitive disorders that may interfere with neurocognitive assessment, including dementia, Alzheimer's disease, Parkinson's disease, or recurrent or persistent delirium within the last 12 months
- Female subjects who are pregnant or breastfeeding
- Patient who had an orbital or eye injury
- It is not possible to perform a qualitative neuropsychological assessment due to other factors (e.g., hearing or vision impairments)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 69 years old?
Where in United States
Also in 3 other countries, 3 sites
- Northwestern Memorial HospitalChicago, United StatesContact: Richa Dhawan, Dr.Not yet recruiting
About the trial
What the trial wants to find out
The purpose of this clinical investigation is to evaluate the clinical performance, safety, and clinical benefit of the BrainProtect System in reducing early postoperative neurological complications in adult participants undergoing elective coronary artery bypass grafting (CABG) with cardiopulmonary bypass (CPB).
Read full original descriptionShow less
The investigation aims to verify the claim that real-time detection and correction of cerebral autoregulation (CA) impairment during CPB improves neurological outcomes compared to standard perioperative management. The study is designed to demonstrate superiority of BrainProtect-guided management over standard care.
This is a Multicenter, two-arm, blinded, randomized controlled pivotal (confirmatory) clinical investigation of a non-CE marked investigational medical device. Adult participants undergoing elective coronary artery bypass graft (CABG) surgery requiring cardiopulmonary bypass (CPB) will be randomized in a 1:1 ratio to either the investigational group or the control group.
In the investigational group, standard perioperative management during CABG with CPB will be performed. Real-time cerebral autoregulation (CA) monitoring using the BrainProtect System will be applied during CPB.
In the control group, standard perioperative management during CABG with CPB will be performed. Conventional systemic hemodynamic monitoring will be used. The BrainProtect System will not be used, and no real-time cerebral autoregulation monitoring data will be available to the clinical team.
Postoperative neurological outcomes (POCD and POD) will be assessed in both groups using predefined standardized neuropsychological tests and CAM-ICU assessments during the early postoperative period. In addition, the length of the index hospitalisation and occurrence of hospital readmission within 31 days after surgery and the reason for readmission will be recorded.
The 2 groups in the trial
- Investigational Group (BrainProtect-guided monitoring)Treatment being tested
Standard perioperative management during CABG with CPB will be performed. Real-time cerebral autoregulation (CA) monitoring using the BrainProtect System will be applied during CPB. After induction of general anaesthesia according to the standard clinical practice of the participating site, the participant will be placed under controlled ventilation and prepared for cardiac surgery. Once the participant is stabilised under anaesthesia, the Archimedes 02 monitoring system will be positioned on the participant's closed eyelids to enable non-invasive monitoring of intracranial pressure pulse waves and cerebral autoregulation related signals. Cardiopulmonary bypass (CPB) will then be initiated using the heart-lung machine (HLM) according to the routine surgical protocol. Following initiation of CPB and confirmation of stable extracorporeal circulation, the BrainProtect Plug-in Modulator will be activated. Rectangular flow modulation will be initiated after stabilization of CPB parameters
Treatment: BrainProtect System and Standard perioperative management
- Control GroupExisting treatment, for comparison
Standard perioperative management during CABG with CPB will be performed. Conventional systemic hemodynamic monitoring will be used. Adjunctive cerebral oxygenation monitoring using near-infrared spectroscopy (NIRS) may be used if routinely applied at the site. The BrainProtect System will not be used, and no real-time cerebral autoregulation monitoring data will be available to the clinical team. Blood pressure management will be performed according to standard institutional protocols without CA-guided intervention.
Treatment: Standard perioperative management
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery Requiring Heart-lung Machine ("BrainProtect")
- Fit questions
- Built from NCT07872982, who can take part
- Record updated
- 14 October 2026