An interventional study of CO2 flushing and Saline flushing in Stroke, Silent Cerebral Infarction and Neurocognitive Dysfunction, sponsored by Imperial College London. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Imperial College London · Not applicable, Interventional, and Prevention
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.
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Imperial College London is the lead sponsor of 842 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Flushing of stent-grafts in TEVAR with carbon-dioxide
Other: CO2 flushing
Flushing of stent-grafts with saline
Other: Saline flushing
As above
As above
Recruitment
The number of patients recruited into the trial will be collected
Time frame: 36 months
Retention
The proportion of patients undergoing follow-up assessments will be collected
Time frame: 36 months
Study design for full randomised controlled trial
The proportion of patients who are eligible for the trial will be collected
Time frame: 36 months
Number, size and location of new ischaemic lesions on post-operative diffusion-weighted MRI scans
Using DW-MRI at \<72 hours post operatively (day 1-7), and also 6 months post operatively, we will assess for new ischaemic lesions
Time frame: 36 months
Number of gaseous and solid intra-operative transcranial doppler microembolic signals by phase of TEVAR
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
Time frame: Duration of surgery, 36 months collection
Number of participants with stroke or delirium as an inpatient
Patients will undergo stroke and delirium assessment.
Time frame: These will be carried out within 48 hours of patients' return to level 1 care. 36 months collection
Serial biomarker blood tests
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
Time frame: 36 months
Risk factor assessment
Data such as stent type will be collected.
Time frame: 36 months
Neurological assessment, delirium assessment and quality of life testing
Patients will undergo a baseline neurocognitive, delirium and quality of life testing. These will be repeated as an outpatient to measure change post operatively.
Time frame: Pre-op, first outpatient assessment (approximately 6 weeks), 6 months. 36 months collection
Plan to share: Yes — Data requests can be made to the corresponding author and make on a case by case basis
Supporting information: Study protocol, Informed consent form
Time frame: 10 years
Access criteria: These will be reviewed on a case by case basis
This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.