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Biomarkers Associated With Postoperative Cognitive Dysfunction

Feasibility Study of the Use of Biomarkers to Detect Perioperative Brain Injury: the Association Between Serum Neurofilament Light Chains, Tau Proteins, Continuous Intra-operative Electroencephalography, and the Development of Post Operative Cognitive Dysfunction After Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05464355
Enrollment
45
Registered
2022-07-19
Start date
2023-01-05
Completion date
2030-01-31
Last updated
2025-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Decline, Cognitive Impairment, Delirium, Postoperative Cognitive Dysfunction

Keywords

Electroencephalography, Delirium, Neurofilament light chain, Tau protein

Brief summary

Loss of cognitive function after major surgery is a significant risk in older people. It can occur acutely in the days after surgery as delirium or in months to years later as a persistent reduction in brain function termed neurocognitive decline. Together these conditions are called post operative cognitive dysfunction (POCD). They can be acutely distressing for patients and are associated with other problems after surgery. The causes of post operative cognitive dysfunction are poorly understood. Studies have been limited by a lack of biomarkers to predict which patients are at high risk of developing POCD. Research suggests silent strokes occurring during surgery and different sensitivities to anaesthetic medicines are associated with POCD. The project consists of a feasibility study to investigate markers that might predict people over 65 years old getting POCD. The first biomarker is a non-invasive monitor of anaesthetics effects on brain function called electroencephalography (EEG): The investigators will identify which EEG patterns predict delirium within five days surgery. The second set of biomarkers are two blood tests of proteins that increase after strokes: these are neurofilament light chains and tau proteins. The investigators will establish if these can be used to predict having POCD up to one year after surgery and long term cognitive impairment up to 5 years after surgery.

Interventions

PROCEDUREIntraoperative electroencephalography recording

Intraoperative electroencephalography measurements, a non-invasive routine monitoring device used during anaesthesia to measure the brain's electrical activity

PROCEDURENeurofilament light chain measurement

Measurement of the level of neurofilament light chain in a blood sample

PROCEDURETau protein measurement

Measurement of the level of tau protein in a blood sample

Sponsors

Oxford University Hospitals NHS Trust
CollaboratorOTHER
University of Oxford
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Greater than or equal to 65 years of age * Having elective non-cardiac surgery under general anaesthesia * Anticipated to have at least 48 hours of inpatient admission * Able & willing to give informed consent

Exclusion criteria

* Unable to participate in neurocognitive assessments * Presence of delirium prior to surgery * Contraindication to use of EEG electrodes (e.g. known allergy to a component of the electrodes) * Known history of severe traumatic brain injury * Learning disability specifically with a known structural brain lesion * Known history of dementia * Participants undergoing operations on the carotid artery

Design outcomes

Primary

MeasureTime frameDescription
Feasibility to conduct the study1 year after surgeryThe total number of participants who are successfully recruited, receive the study procedures and complete both 90 day and 1 year follow up after surgery.

Secondary

MeasureTime frameDescription
Postoperative delirium incidence and severityUp to 5 days after surgeryPostoperative delirium identified as being present according to a positive result using 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) and severity according to the absolute value on the 3D-CAM-Severity which is a scale converting the 3-Minute Diagnostic Interview for Confusion Assessment Method into a scale from 0-7. Higher scores are associated with worse outcome.
Days alive and at home up to 90 days after surgery90 days after surgeryThe number of days a participant is alive and how many are spent at home after surgery
Change in neurofilament light chains and tau proteins levels pre- to post operativelyUp to 2 days after surgeryMeasurements of the level of the biomarkers neurofilament light chain and tau protein in plasma
Postoperative neurocognitive dysfunction and severityUp to 1 year after surgeryCognitive impairment measured on Montreal Objective Cognitive Assessment administered by telephone. The scale is 0-22 with higher scores representing better outcome.
Long term cognitive impairmentUp to 5 years after surgeryIncidence of new diagnosis in primary or secondary care of dementia or mild cognitive impairment

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026