INTERCEPT:GP: Intervention With Cerebral Embolic Protection in TEVAR: Gaseous Protection

Sponsor

Imperial College London (Other)

Overall Status

Unknown status

CT.gov ID

NCT03886675

Collaborator

Imperial College Healthcare NHS Trust (Other), Guy's and St Thomas' NHS Foundation Trust (Other), St George's University Hospitals NHS Foundation Trust (Other), Cambridge University Hospitals NHS Foundation Trust (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Silent Cerebral Infarction Neurocognitive Dysfunction Vascular Brain Injury	Other: CO2 flushing Other: Saline flushing	N/A

Detailed 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 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 Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 randomisation1:1 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

Anticipated Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: carbon-dioxide Flushing of stent-grafts in TEVAR with carbon-dioxide	Other: CO2 flushing As above
Active Comparator: Saline Flushing of stent-grafts with saline	Other: Saline flushing As above

Arm

Intervention/Treatment

Experimental: carbon-dioxide

Flushing of stent-grafts in TEVAR with carbon-dioxide

Other: CO2 flushing

As above

Active Comparator: Saline

Flushing of stent-grafts with saline

Other: Saline flushing

As above

Outcome Measures

Primary Outcome Measures

Number of participants with new diffusion-weighted MRI brain scan [Within 72hrs]
As above

Secondary Outcome Measures

Number, size and location of new ischaemic lesions on post-operative diffusion-weighted MRI scans [Within 72hrs]
As above
Number of gaseous and solid intra-operative transcranial doppler microembolic signals by phase of TEVAR [Duration of surgery]
As above
Stroke rate [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 [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