Clinical trial NCT02308566: 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
Official title: Aortic Valve Replacement Using Closed Extracorporeal Circuit. Minimized Versus Conventional Extracorporeal Circulation Technique: Qualitative Differences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aortic Valve Stenosis
Extracorporeal Circulation
Keywords: Intracranial Embolism
Ultrasonography, Doppler, Transcranial
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators aim to compare cerebral embolic load in patients undergoing surgical aortic valve replacement using either the minimized extracorporeal circulation or the conventional extracorporeal circulation technique. The detection of cerebral emboli is performed not-invasively by transcranial Doppler detection of high-intensity transient signals representing solid or gaseous microembolism in the middle cerebral arteries. The investigators hope to get more insight in the mechanism (incl. quantity) of cerebral embolism during aortic valve surgery using extracorporeal circulation.

Detailed description: Background

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.

Eligibility criteria: Inclusion Criteria:

* Isolated Severe Aortic Valve Stenosis
* No other cardiac disease
* No other coronary heart disease
* Written informed consent

Exclusion Criteria

* Double valve surgery
* Concomitant coronary artery bypass surgery
* Vascular surgery
* Age \< 18 yrs.
* Age \> 80 yrs.

Primary outcomes:
measure: Total and interval-related cerebral microembolic load as measured by transcranial Doppler
timeFrame: Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs)
Secondary outcomes:
measure: Cerebral complications, e.g. delirium and stroke as detected clinically
timeFrame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
measure: Redo surgery
timeFrame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
measure: ICU length of stay
timeFrame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
measure: Extubation time
timeFrame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
measure: Thromboembolic complications
timeFrame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
measure: In-hospital infections
timeFrame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
measure: In-hospital Mortality
timeFrame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Bern
Study officials:
affiliation: Department of Cardiovascular Surgery
name: Thierry Carrel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: