Stroke Clinical Trial
— INTERCEPT:GPOfficial title:
Carbon-Dioxide Flushing Versus Saline Flushing in Thoracic Endovascular Aortic Repair to Reduce Neurological Injury: A Pilot Randomised Controlled Trial
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College London | London |
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 |
United Kingdom,
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
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 |
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