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Cerebral Protection in Aortic Arch Surgery

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jul 19, 2026 → Oct 19, 2026
See other at-risk trials from Barts & The London NHS Trust

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Enrollment reopened
    • Primary and study completion pushed from Jul 19, 2026 to Oct 19, 2026
    • Site details revised
    v10
  2. Notable Primary and study completion dates: Aug 31, 2025 to Jul 19, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Start date: Aug 1, 2023 to Jul 19, 2023
    • Site details revised
    v9
  3. Notable Primary and study completion dates: Aug 31, 2024 to Aug 31, 2025v8
  4. Minor Re-verified, no change to tracked fieldsv7
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Start date: Feb 1, 2023 to Aug 1, 2023v5
  2. Minor Study description revisedv4
  3. Notable Start date: May 1, 2022 to Feb 1, 2023
    • Study description expanded, about 916 words
    v3
  4. Notable Start date: Sep 1, 2021 to May 1, 2022v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04966247
Lead Sponsor Barts & The London NHS Trust
Collaborators: Queen Mary University of London, Imperial College London
Conditions
(from sponsor)
Aortic Aneurysm, Aortic Dissection, Aortic Arch, Aortic Diseases
Related terms Aortic Aneurysm, Aortic Diseases, Aortic Dissection
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov