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

October 19, 2023 updated by: Imperial College London

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment
Time Frame: 36 months
The number of patients recruited into the trial will be collected
36 months
Retention
Time Frame: 36 months
The proportion of patients undergoing follow-up assessments will be collected
36 months
Study design for full randomised controlled trial
Time Frame: 36 months
The proportion of patients who are eligible for the trial will be collected
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number, size and location of new ischaemic lesions on post-operative diffusion-weighted MRI scans
Time Frame: 36 months
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
Number of gaseous and solid intra-operative transcranial doppler microembolic signals by phase of TEVAR
Time Frame: Duration of surgery, 36 months collection
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
Number of participants with stroke or delirium as an inpatient
Time Frame: These will be carried out within 48 hours of patients' return to level 1 care. 36 months collection
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
Serial biomarker blood tests
Time Frame: 36 months
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
Risk factor assessment
Time Frame: 36 months
Data such as stent type will be collected.
36 months
Neurological assessment, delirium assessment and quality of life testing
Time Frame: Pre-op, first outpatient assessment (approximately 6 weeks), 6 months. 36 months collection
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

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

Investigators

  • Principal Investigator: Richard Gibbs, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2022

Primary Completion (Estimated)

June 6, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

March 20, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (Actual)

March 22, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INTERCEPT:GP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data requests can be made to the corresponding author and make on a case by case basis

IPD Sharing Time Frame

10 years

IPD Sharing Access Criteria

These will be reviewed on a case by case basis

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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