BrainProtect System for Postoperative Cognitive Dysfunction
(BrainProtect Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
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.
Are You a Good Fit for This Trial?
This trial is for adults scheduled to have elective coronary artery bypass surgery using a heart-lung machine. Participants must be able to undergo standard surgical care and monitoring.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- BrainProtect System
Trial Overview
The study compares two approaches during heart surgery: one group gets real-time brain blood flow monitoring with the BrainProtect System, while the other receives usual care without this device. Patients are randomly assigned to each group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Scienceforbrain, UAB
Lead Sponsor
KCRI
Collaborator
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