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 (AKE-MECC)

June 29, 2016 updated by: University Hospital Inselspital, Berne

Aortic Valve Replacement Using Closed Extracorporeal Circuit. Minimized Versus Conventional Extracorporeal Circulation Technique: Qualitative Differences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • University Hospital Bern

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Extracorporeal Circulation Technique
Procedure: Conventional Extracorporeal Circulation (CECC)
This group of patients receives surgical aortic valve replacement using CECC.
Experimental: Minimized Extracorporeal Circulation Technique
Procedure: Minimized Extracorporeal Circulation (MECC)
This group of patients receives surgical aortic valve replacement using MECC.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Thierry Carrel, MD, PhD, Department of Cardiovascular Surgery

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

June 1, 2011

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Estimate)

June 30, 2016

Last Update Submitted That Met QC Criteria

June 29, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 034/11

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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