Neurocognitive Dysfunction, Silent Cerebral Infarction, Stroke, Vascular Brain Injury
Conditions
Keywords
Stroke, Silent cerebral infarction, Carbon dioxide, Thoracic endovascular aortic repair, TEVAR, DW-MRI, Vascular brain infarction
Brief summary
Vascular brain infarction (VBI) occurs in 67% of patients undergoing TEVAR. Overt stroke occurs in 13% of these patients and 88% of patients suffer from neurocognitive impairment. Cerebral air embolisation during the stent-graft deployment phase of TEVAR may be a cause of VBI. Standard treatment to de-air stent-grafts is through the use of a saline flush. This study aims to investigate whether carbon-dioxide or saline is the better fluid to de-air TEVAR stent-grafts prior to insertion in to the patient and compare VBI rate in the carbon-dioxide group and saline group.
Detailed description
Thoracic endovascular aortic repair (TEVAR) is the re-lining of the thoracic aorta to prevent life threatening haemorrhage and death from rupture. This involves a small cut in the femoral artery in the groin and under imaging guidance, the insertion of wires and a stent into the thoracic aorta. Prior to insertion into the patient, stents are flushed with saline to remove air and prevent air reaching the brain that can cause a form of brain injury known as vascular brain infarction (VBI). However, our preliminary clinical data suggests that saline flushing is not effective at de-airing stent-grafts used in TEVAR. Carbon-dioxide has been used extensively in cardiac surgery to displace air from the chest cavity to prevent peri-procedural cerebral air embolisation. We hypothesise that flushing the stent-grafts with carbon-dioxide may be better at removing air from the stent-grafts than saline flush. Patients undergoing TEVAR will be approached to participate in this study. After written consent is obtained, participants will be randomised to undergo (TEVAR) with carbon dioxide or saline flushing of stent-grafts. Pre-operatively, participants will undergo extensive neurocognitive testing, and a baseline blood test. Intra-operatively, participants will undergo continuous transcranial doppler monitoring (TCD) of the middle cerebral artery (MCA) to look for cerebral air embolisation at stent-graft deployment phase of TEVAR. Blood testing pre-op, immediately post op, and 24 hours post op will be taken to measure for biomarkers of brain injury. Post-operatively, participants will undergo another diffusion-weighted brain MRI within 72 hours post-procedure, stroke and delirium assessment at day 1, 3 and day 7 +/- day of discharge, and at 6-weeks and 6-month follow-up.
Interventions
OTHERCO2 flushing
As above
OTHERSaline flushing
As above
Sponsors
Imperial College Healthcare NHS Trust
Guy's and St Thomas' NHS Foundation Trust
St George's University Hospitals NHS Foundation Trust
University Hospitals Coventry and Warwickshire NHS Trust
South Canterbury DHB, New Zealand
Baylor Scott and White Health
University Hospital Southampton NHS Foundation Trust
Health New Zealand
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be blinded to treatment allocation. Assessment of TCD embolic data, DW-MRI scan reporting and neurological and neurocognitive assessment will be carried out by blinded trained assessors.
Intervention model description
1:1 randomisation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All participants suitable for TEVAR with capacity to consent
Exclusion criteria
* Participants who lack capacity to consent * Contraindications to MRI such as pacemaker * Pregnant participants * Participants who do not wish to participate * Participants \<18yrs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 36 months | The number of patients recruited into the trial will be collected |
| Retention | 36 months | The proportion of patients undergoing follow-up assessments will be collected |
| Study design for full randomised controlled trial | 36 months | The proportion of patients who are eligible for the trial will be collected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serial biomarker blood tests | 36 months | Blood samples will be taken preoperatively, at the end of the procedure and 24 hours late. These will be analysed for a biomarker of neuroglial injury, S100B |
| Number, size and location of new ischaemic lesions on post-operative diffusion-weighted MRI scans | 36 months | Using DW-MRI at \<72 hours post operatively (day 1-7), and also 6 months post operatively, we will assess for new ischaemic lesions |
| Neurological assessment, delirium assessment and quality of life testing | Pre-op, first outpatient assessment (approximately 6 weeks), 6 months. 36 months collection | Patients will undergo a baseline neurocognitive, delirium and quality of life testing. These will be repeated as an outpatient to measure change post operatively. |
| Risk factor assessment | 36 months | Data such as stent type will be collected. |
| Number of gaseous and solid intra-operative transcranial doppler microembolic signals by phase of TEVAR | Duration of surgery, 36 months collection | At all London units, transcranial doppler insonation of the middle cerebral artery will be carried out during the procedure, and analysed offline at a later date to evaluate gaseous or solid emboli during TEVAR |
| Number of participants with stroke or delirium as an inpatient | These will be carried out within 48 hours of patients' return to level 1 care. 36 months collection | Patients will undergo stroke and delirium assessment. |
Countries
United Kingdom
Contacts
Primary ContactLydia Hanna
Backup ContactRichard Gibbs
Outcome results
None listed