NCT05464355Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 22 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 45 (estimated)
- First submitted
- 11 Jul 2022
- Start date
- 5 Jan 2023
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- University of Oxford
- NCT number
- NCT05464355
What you commit to
- Study type: Observational
- Planned participants: 45
- From 5 Jan 2023 to the primary completion date, 31 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of delirium prior to surgery
Other illness
- Contraindication to use of EEG electrodes (e.g. known allergy to a component of the electrodes)
- Known history of severe traumatic brain injury
- Known history of dementia
Other
- Unable to participate in neurocognitive assessments
- Learning disability specifically with a known structural brain lesion
- Participants undergoing operations on the carotid artery
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Berkshire NHS Foundation Trust Coordinator of this site? Confirm its status | Reading | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.