Comparing carbon dioxide and saline for preventing brain injury during aortic repair
Carbon-Dioxide Flushing Versus Saline Flushing in Thoracic Endovascular Aortic Repair to Reduce Neurological Injury: A Pilot Randomised Controlled Trial
This study is testing whether using carbon dioxide instead of saline to flush stent-grafts during aortic repair can help prevent brain injuries and strokes in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT03886675 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of carbon dioxide versus saline in flushing stent-grafts used in thoracic endovascular aortic repair (TEVAR) to prevent vascular brain injury (VBI). Patients undergoing TEVAR will be randomly assigned to receive either carbon dioxide or saline flushing before the stent-graft insertion. The study will involve pre-operative neurocognitive testing and continuous monitoring of cerebral air embolisation during the procedure. The goal is to determine which flushing method better reduces the risk of stroke and neurocognitive dysfunction associated with TEVAR.
Who should consider this trial
Good fit: Ideal candidates are adults who are suitable for TEVAR and have the capacity to consent.
Not a fit: Patients who are under 18 years old, pregnant, or have contraindications to MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of stroke and cognitive impairment in patients undergoing TEVAR.
How similar studies have performed: Preliminary clinical data suggests that carbon dioxide may be more effective than saline for this purpose, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London
- Imperial College London — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Richard Gibbs — Imperial College London
- Study coordinator: Lydia Hanna
- Email: l.hanna@imperial.ac.uk
- Phone: 07747002704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.