Cerebral Embolic Load in Patients Undergoing Surgical Aortic Valve Replacement: A Comparison of the Conventional With the Minimized Extracorporeal Circulation Technique Using Transcranial Doppler Ultrasound
NCT ID: NCT02308566
Last Updated: 2016-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
48 participants
INTERVENTIONAL
2011-06-30
2016-06-30
Brief Summary
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Detailed Description
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The gold standard to treat severe aortic valve stenosis is currently the surgical aortic valve replacement (SAVR) using conventional extracorporeal circulation (CECC). SAVR, however, can be performed also on minimized extracorporeal circulation (MECC), which is characterized by reduced priming volume and interfaces between blood and artificial surfaces and blood-air interface, respectively. Further technical developments of the MECC system together with reports on less induction of the coagulation cascade and activation of inflammatory systemic response may account for a reduced incidence of microbubble generation with MECC system.
Objective
The aim of the is to investigate the procedural-related incidence of high-intensity transient signals (HITS) representing solid or gaseous microembolism reaching the cerebral vessels.
Methods
Patients undergoing SAVR are included in the study and randomised to either MECC or CECC technique. HITS are continuously bilaterally detected during the entire intraoperative period by transcranial Doppler ultrasound.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional Extracorporeal Circulation Technique
Conventional Extracorporeal Circulation Technique
Conventional Extracorporeal Circulation (CECC)
This group of patients receives surgical aortic valve replacement using CECC.
Minimized Extracorporeal Circulation Technique
Minimized Extracorporeal Circulation Technique
Minimized Extracorporeal Circulation (MECC)
This group of patients receives surgical aortic valve replacement using MECC.
Interventions
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Minimized Extracorporeal Circulation (MECC)
This group of patients receives surgical aortic valve replacement using MECC.
Conventional Extracorporeal Circulation (CECC)
This group of patients receives surgical aortic valve replacement using CECC.
Eligibility Criteria
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Inclusion Criteria
* No other cardiac disease
* No other coronary heart disease
* Written informed consent
Exclusion Criteria
* Concomitant coronary artery bypass surgery
* Vascular surgery
* Age \< 18 yrs.
* Age \> 80 yrs.
18 Years
80 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Thierry Carrel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiovascular Surgery
Locations
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University Hospital Bern
Bern, , Switzerland
Countries
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Other Identifiers
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034/11
Identifier Type: -
Identifier Source: org_study_id
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