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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)

Primary Purpose

Aortic Valve Stenosis, Extracorporeal Circulation

Status

Completed

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Minimized Extracorporeal Circulation (MECC)

Conventional Extracorporeal Circulation (CECC)

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Intracranial Embolism, Ultrasonography, Doppler, Transcranial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Hospital Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Extracorporeal Circulation Technique

Minimized Extracorporeal Circulation Technique

Arm Description

Conventional Extracorporeal Circulation Technique

Minimized Extracorporeal Circulation Technique

Outcomes

Primary Outcome Measures

Total and interval-related cerebral microembolic load as measured by transcranial Doppler

Secondary Outcome Measures

Cerebral complications, e.g. delirium and stroke as detected clinically

Redo surgery

ICU length of stay

Extubation time

Thromboembolic complications

In-hospital infections

In-hospital Mortality

Full Information

NCT ID

NCT02308566

First Posted

December 2, 2014

Last Updated

June 29, 2016

Sponsor

Insel Gruppe AG, University Hospital Bern

1. Study Identification

Unique Protocol Identification Number

NCT02308566

Brief Title

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

Acronym

AKE-MECC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis, Extracorporeal Circulation

Keywords

Intracranial Embolism, Ultrasonography, Doppler, Transcranial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional Extracorporeal Circulation Technique

Arm Type

Active Comparator

Arm Description

Conventional Extracorporeal Circulation Technique

Arm Title

Minimized Extracorporeal Circulation Technique

Arm Type

Experimental

Arm Description

Minimized Extracorporeal Circulation Technique

Intervention Type

Procedure

Intervention Name(s)

Minimized Extracorporeal Circulation (MECC)

Intervention Description

This group of patients receives surgical aortic valve replacement using MECC.

Intervention Type

Procedure

Intervention Name(s)

Conventional Extracorporeal Circulation (CECC)

Intervention Description

This group of patients receives surgical aortic valve replacement using CECC.

Primary Outcome Measure Information:

Title

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)

Secondary Outcome Measure Information:

Title

Cerebral complications, e.g. delirium and stroke as detected clinically

Time Frame