Intervention With Cerebral Embolic Protection in TEVAR: gaseous Protection

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2022
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.
Epistemonikos ID: 3dcad6b644a2f4206a0d95b64420add9349e3ee8
First added on: May 22, 2024