Cerebral Protection in Aortic Arch Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBarts & The London NHS Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing aortic arch surgery

Patients aged 18 and over

Patients who are able to provide informed consent

Disqualifiers

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)

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Microdialysis

    Other intervention

    Monitoring real-time cerebral biomarkers using microdialysis method

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Patients with Aortic Arch Pathology1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with postoperative stroke

New onset stroke after surgery

Time frame
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

New onset delirium after surgery will be assessed using the "Confusion Assessment Method (CAM)"

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Barts & The London NHS Trust

Lead sponsor

Queen Mary University of London

Collaborator

Imperial College London

Collaborator