Intervention With Cerebral Embolic Protection in TEVAR: Gaseous Protection

Stroke Clinical Trial

— INTERCEPT:GP  

Official title:

Carbon-Dioxide Flushing Versus Saline Flushing in Thoracic Endovascular Aortic Repair to Reduce Neurological Injury: A Pilot Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03886675
• Other study ID #: INTERCEPT:GP
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: Imperial College London
• Contact: Lydia Hanna
• Phone: 07747002704
• Email: l.hanna[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2024
• Est. primary completion date: June 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Cerebral Infarction
• Cerebrovascular Trauma
• Cognitive Dysfunction
• Infarction
• Neurocognitive Dysfunction
• Silent Cerebral Infarction
• Stroke
• Vascular Brain Injury

Intervention

Other:
• CO2 flushing
As above
• Saline flushing
As above

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (9)

Lead Sponsor	Collaborator
Imperial College London	Baylor Scott and White Health, Guy's and St Thomas' NHS Foundation Trust, Health New Zealand, Imperial College Healthcare NHS Trust, South Canterbury DHB, New Zealand, St George's University Hospitals NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (8)

Bismuth J, Garami Z, Anaya-Ayala JE, Naoum JJ, El Sayed HF, Peden EK, Lumsden AB, Davies MG. Transcranial Doppler findings during thoracic endovascular aortic repair. J Vasc Surg. 2011 Aug;54(2):364-9. doi: 10.1016/j.jvs.2010.12.063. Epub 2011 Mar 3. — View Citation

Ganguly G, Dixit V, Patrikar S, Venkatraman R, Gorthi SP, Tiwari N. Carbon dioxide insufflation and neurocognitive outcome of open heart surgery. Asian Cardiovasc Thorac Ann. 2015 Sep;23(7):774-80. doi: 10.1177/0218492315583562. Epub 2015 May 4. — View Citation

Inci K, Koutouzi G, Chernoray V, Jeppsson A, Nilsson H, Falkenberg M. Air bubbles are released by thoracic endograft deployment: An in vitro experimental study. SAGE Open Med. 2016 Dec 7;4:2050312116682130. doi: 10.1177/2050312116682130. eCollection 2016. — View Citation

Kahlert P, Eggebrecht H, Janosi RA, Hildebrandt HA, Plicht B, Tsagakis K, Moenninghoff C, Nensa F, Mummel P, Heusch G, Jakob HG, Forsting M, Erbel R, Schlamann M. Silent cerebral ischemia after thoracic endovascular aortic repair: a neuroimaging study. Ann Thorac Surg. 2014 Jul;98(1):53-8. doi: 10.1016/j.athoracsur.2014.03.037. Epub 2014 May 17. — View Citation

Martens S, Neumann K, Sodemann C, Deschka H, Wimmer-Greinecker G, Moritz A. Carbon dioxide field flooding reduces neurologic impairment after open heart surgery. Ann Thorac Surg. 2008 Feb;85(2):543-7. doi: 10.1016/j.athoracsur.2007.08.047. — View Citation

Masada K, Kuratani T, Shimamura K, Kin K, Shijo T, Goto T, Sawa Y. Silent cerebral infarction after thoracic endovascular aortic repair: a magnetic resonance imaging study. Eur J Cardiothorac Surg. 2019 Jun 1;55(6):1071-1078. doi: 10.1093/ejcts/ezy449. — View Citation

Perera AH, Rudarakanchana N, Monzon L, Bicknell CD, Modarai B, Kirmi O, Athanasiou T, Hamady M, Gibbs RG. Cerebral embolization, silent cerebral infarction and neurocognitive decline after thoracic endovascular aortic repair. Br J Surg. 2018 Mar;105(4):366-378. doi: 10.1002/bjs.10718. Epub 2018 Feb 12. — View Citation

Rohlffs F, Tsilimparis N, Saleptsis V, Diener H, Debus ES, Kolbel T. Air Embolism During TEVAR: Carbon Dioxide Flushing Decreases the Amount of Gas Released from Thoracic Stent-Grafts During Deployment. J Endovasc Ther. 2017 Feb;24(1):84-88. doi: 10.1177/1526602816675621. Epub 2016 Oct 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	The number of patients recruited into the trial will be collected	36 months
Primary	Retention	The proportion of patients undergoing follow-up assessments will be collected	36 months
Primary	Study design for full randomised controlled trial	The proportion of patients who are eligible for the trial will be collected	36 months
Secondary	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	36 months
Secondary	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	Duration of surgery, 36 months collection
Secondary	Number of participants with stroke or delirium as an inpatient	Patients will undergo stroke and delirium assessment.	These will be carried out within 48 hours of patients' return to level 1 care. 36 months collection
Secondary	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	36 months
Secondary	Risk factor assessment	Data such as stent type will be collected.	36 months
Secondary	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.	Pre-op, first outpatient assessment (approximately 6 weeks), 6 months. 36 months collection