Carbon-Dioxide Flushing Versus Saline Flushing in Thoracic Endovascular Aortic Repair to Reduce Neurological Injury: A Pilot Randomised Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• All participants suitable for TEVAR with capacity to consent
Locations
Other Locations
United Kingdom
Imperial College London
RECRUITING
London
Contact Information
Primary
Lydia Hanna
l.hanna@imperial.ac.uk
07747002704
Backup
Richard Gibbs
r.gibbs@nhs.net
Time Frame
Start Date: 2022-11-14
Estimated Completion Date: 2024-10
Participants
Target number of participants: 120
Treatments
Experimental: carbon-dioxide
Flushing of stent-grafts in TEVAR with carbon-dioxide
Active_comparator: Saline
Flushing of stent-grafts with saline
Related Therapeutic Areas
Sponsors
Collaborators: St George's University Hospitals NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, South Canterbury DHB, New Zealand, Health New Zealand, Imperial College Healthcare NHS Trust, Guy's and St Thomas' NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, Baylor Scott and White Health
Leads: Imperial College London