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

Phase 4

Completed

• Conditions: Aortic Valve Stenosis; Extracorporeal Circulation
• Interventions: Procedure: Conventional Extracorporeal Circulation (CECC); Procedure: Minimized Extracorporeal Circulation (MECC)

• Registration Number: NCT02308566
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-04
• Primary Completion: 2016-03
• Status Verified: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-29
• Last Update Posted: 2016-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Extracorporeal Circulation Technique	Conventional Extracorporeal Circulation (CECC)	Conventional Extracorporeal Circulation Technique
Minimized Extracorporeal Circulation Technique	Minimized Extracorporeal Circulation (MECC)	Minimized Extracorporeal Circulation Technique

Primary Outcome Measures

Name	Time	Method
Total and interval-related cerebral microembolic load as measured by transcranial Doppler	Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs)

Secondary Outcome Measures

Name	Time	Method
Cerebral complications, e.g. delirium and stroke as detected clinically	In-hospital period (until hospital discharge, duration approx. 7-10 days)
Redo surgery	In-hospital period (until hospital discharge, duration approx. 7-10 days)
In-hospital Mortality	In-hospital period (until hospital discharge, duration approx. 7-10 days)
Extubation time	In-hospital period (until hospital discharge, duration approx. 7-10 days)
In-hospital infections	In-hospital period (until hospital discharge, duration approx. 7-10 days)
ICU length of stay	In-hospital period (until hospital discharge, duration approx. 7-10 days)
Thromboembolic complications	In-hospital period (until hospital discharge, duration approx. 7-10 days)

Trial Locations

Locations (1)

University Hospital Bern; 🇨🇭 Bern, Switzerland