Cerebral Protection in Aortic Arch Surgery

NCT04966247 | Active Not Recruiting DMC

• 1 other identifier: 299015
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Aortic arch repair surgery is a technically complex and challenging procedure to treat aortic pathologies. Despite advancements in perioperative care, detrimental neurological complications occur during or after surgery. The neurological complications increase the economic burden of healthcare, morbidity and quality of life for the patients, even if they survive. Stroke, for example, leads to an increase in healthcare and social care costs, requiring a subsequent lengthy rehabilitation. Milder neurological impairments include transient ischaemic attacks, confusion and delirium, necessitating longer intensive care and hospital stay. Currently applied cerebral monitoring modalities are electroencephalogram and cerebral oximetry. However, they are not specific enough to timely detect early cerebral ischaemia to prevent neurological complications. S100B protein and neuron-specific enolase are serum markers that reflect cerebral damage, however, their applicability in the hyperacute setting is limited. However, rapid measurements of glial fibrillary protein have paved new pathways to detect cerebral injury. Recent studies reveal more sensitive biomarkers of glucose, lactate, pyruvate, glutamate and glycerol. These biomarkers could potentially detect cerebral ischaemia on a near real-time basis using the microdialysis method. The aim of the project is to develop a bedside system for early detection of cerebral ischaemia on a near real-time basis during aortic arch surgery. Early detection of cerebral ischaemia could mandate more aggressive cerebral protection strategies by further optimisation of hypothermia and antegrade selective cerebral perfusion during surgery, and optimisation of blood pressure and oxygenation in the intensive care unit. Ultimately, early detection of cerebral ischemia during surgery will prevent disabling and costly neurological complications following surgery.

Conditions

Aortic Aneurysm; Aortic Dissection; Aortic Arch; Aortic Diseases

Outcome Measures

Primary Outcomes (1)

• Number of participants with postoperative stroke

  New onset stroke after surgery

  From the start of surgery until patient is discharged from the hospital, an average of 7 days

Secondary Outcomes (1)

• Number of participants with postoperative delirium

  From the start of surgery until patient is discharged from the hospital, an average of 7 days

Study Arms (1)

Patients with Aortic Arch Pathology

Patients undergoing aortic arch surgery for aortic arch pathologies, such as aortic aneurysm and aortic dissection.

Other: Microdialysis

Interventions

Microdialysis OTHER

Monitoring real-time cerebral biomarkers using microdialysis method

Patients with Aortic Arch Pathology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study focuses on patients undergoing aortic arch surgery secondary to aortic pathologies such as aortic aneurysm and aortic dissection.

You may qualify if:

• Patients undergoing aortic arch surgery
• Patients aged 18 and over
• Patients who are able to provide informed consent

You may not qualify if:

• Patients with intraoperative death
• Patients with preoperative neurological dysfunction
• Patients who are not able to provide informed consent (language barrier, unconscious, unable to understand, retain and process information)

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Imperial College London: collaborator
• Queen Mary University of London: collaborator

Study Sites (1)

St Bartholomew's Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm; Aortic Dissection; Aortic Diseases

Interventions

Microdialysis

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome

Intervention Hierarchy (Ancestors)

Dialysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Aung Ye Oo, MD, FRCS-CTh

  Queen Mary University London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 19, 2021
• Study Start: July 19, 2023
• Primary Completion (Estimated): July 19, 2026
• Study Completion (Estimated): July 19, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)