Examining associations between proteins in the blood and cognitive function among patients undergoing cardiac and non-cardiac surgery (BRAIN-S)

Using biomarkers of neurological injury to predict cognitive function after cardiac and non-cardiac anaesthesia and surgery (BRAIN-S)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12620000254998

Acronym

BRAIN-S

Enrollment

Registered

2020-02-26

Start date

2021-04-07

Completion date

Unknown

Last updated

2022-06-13

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

Conditions

None listed

Brief summary

Recent preliminary findings suggest markers of neuronal damage (neurofilament light and tau) are associated with general anesthesia and surgery, which in turn may be associated with the clinical outcomes of delirium and postoperative cognitive dysfunction. Specifically, in a pilot study we observed that people undergoing cardiac surgery showed greater increases in plasma neurofilament light and tau than those undergoing non-cardiac surgery. The aim of this investigation is to compare the plasma levels of NFL and tau after cardiac compared to non-cardiac surgery and relate these levels to the subsequent neurocognitive outcomes in the postoperative period. Cognitive and memory testing will take place prior to surgery, at 7 days after surgery and at 3 months after surgery. Tests for delirium and collection of blood samples will also be conducted during the participants' time in hospital.

Interventions

Patients undergoing major elective cardiac and non-cardiac surgery will be recruited for this study. We will quantitate the change in two blood biomarkers of neurological damage (neurofilament light and tau) after cardiac compared to non-cardiac surgery. We will also examine these biomarkers to the subsequent neurocognitive outcomes in the postoperative period. All anaesthesia and surgery will be undertaken according to normal clinical practice. Participants will be followed over 3 months.

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Greater than or equal to 65 years of age 2. Scheduled for elective cardiac or non-cardiac surgery (excluding valvular surgery, to avoid confounding factors of solid and air emboli) 3. Elective non-cardiac surgery procedures anticipated to last greater than one hour 4. Have no contraindication to neuropsychological testing (e.g. language, visual or hearing impairment) 5. Reside in an accessible proximity to the hospital for neuropsychological testing

Exclusion criteria

1. Pre-existing neurological or clinically evident neurovascular disease (e.g. stroke) 2. Dementia of any aetiology 3. Undergone general anaesthetic in past 6 months 4. Associated medical problems that may lead to significant complications and loss to follow-up

Outcome results