Intervention With Cerebral Embolic Protection in TEVAR: Gaseous Protection (INTERCEPT:GP)
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| ClinicalTrials.gov Identifier: NCT03886675 |
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Recruitment Status : Unknown
Verified May 2019 by Imperial College London.
Recruitment status was: Not yet recruiting
First Posted : March 22, 2019
Last Update Posted : May 9, 2019
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stroke Silent Cerebral Infarction Neurocognitive Dysfunction Vascular Brain Injury | Other: CO2 flushing Other: Saline flushing | Not Applicable |
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 a diffusion-weighted MRI brain scan, full neurological examination and neurocognitive testing. 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. Post-operatively, particpants will undergo another diffusion-weighted brain MRI within 72 hours post-procedure, neurological examination for the first 7 days, and neurocognitive tests prior to discharge, and at 6-weeks and 6-month follow-up.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 76 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | 1:1 randomisation |
| Masking: | Double (Participant, Outcomes Assessor) |
| Masking Description: | Participants will be blinded to treatment allocation. Assessment of TCD embolic data, DW-MRI scan reporting and neurological and neurocognitive assessment will be carried out by blinded trained assessors. |
| Primary Purpose: | Prevention |
| Official Title: | Carbon-Dioxide Flushing Versus Saline Flushing in Thoracic Endovascular Aortic Repair to Reduce Neurological Injury: A Pilot Randomised Controlled Trial |
| Estimated Study Start Date : | August 1, 2019 |
| Estimated Primary Completion Date : | April 2021 |
| Estimated Study Completion Date : | October 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: carbon-dioxide
Flushing of stent-grafts in TEVAR with carbon-dioxide
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Other: CO2 flushing
As above |
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Active Comparator: Saline
Flushing of stent-grafts with saline
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Other: Saline flushing
As above |
- Number of participants with new diffusion-weighted MRI brain scan [ Time Frame: Within 72hrs ]As above
- Number, size and location of new ischaemic lesions on post-operative diffusion-weighted MRI scans [ Time Frame: Within 72hrs ]As above
- Number of gaseous and solid intra-operative transcranial doppler microembolic signals by phase of TEVAR [ Time Frame: Duration of surgery ]As above
- Stroke rate [ Time Frame: 1-7 days within hospital, 6-weeks post-operatively and 6-months post-operatively. ]Number of neurological events up to 7 days in hospital, and at 6-week and 6-months follow-up
- Number of participants with neurocognitive impairment from baseline [ Time Frame: 3-7 days post-operatively, 6-weeks post-operatively and 6-months post-operatively. ]Comparison of pre-operative and post-operative neurocognitive tests at discharge, and at 6-weeks and 6-months follow-up
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886675
| Contact: Lydia Hanna | 07747002704 | l.hanna@imperial.ac.uk | |
| Contact: Richard Gibbs | r.gibbs@nhs.net |
| United Kingdom | |
| Imperial College London | |
| London, United Kingdom, W2 1NY | |
| Contact: Ruth Nicholson r.nicholson@imperial.ac.uk | |
| Principal Investigator: | Richard Gibbs | Imperial College London |
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT03886675 |
| Other Study ID Numbers: |
INTERCEPT:GP |
| First Posted: | March 22, 2019 Key Record Dates |
| Last Update Posted: | May 9, 2019 |
| Last Verified: | May 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Stroke Silent cerebral infarction Carbon dioxide Thoracic endovascular aortic repair |
TEVAR DW-MRI Vascular brain infarction |
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Brain Injuries Cerebral Infarction Cerebrovascular Trauma Infarction Cognitive Dysfunction Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Ischemia Pathologic Processes Necrosis Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Brain Infarction Brain Ischemia Cognition Disorders Neurocognitive Disorders Mental Disorders |