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

Aortic Valve Stenosis Clinical Trial

— AKE-MECC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02308566
• Other study ID #: 034/11
• Status: Completed
• Phase: Phase 4
• First received: December 2, 2014
• Last updated: June 29, 2016
• Start date: June 2011
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Extracorporeal Circulation

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total and interval-related cerebral microembolic load as measured by transcranial Doppler		Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs)	No
Secondary	Cerebral complications, e.g. delirium and stroke as detected clinically		In-hospital period (until hospital discharge, duration approx. 7-10 days)	No
Secondary	Redo surgery		In-hospital period (until hospital discharge, duration approx. 7-10 days)	No
Secondary	ICU length of stay		In-hospital period (until hospital discharge, duration approx. 7-10 days)	No
Secondary	Extubation time		In-hospital period (until hospital discharge, duration approx. 7-10 days)	No
Secondary	Thromboembolic complications		In-hospital period (until hospital discharge, duration approx. 7-10 days)	No
Secondary	In-hospital infections		In-hospital period (until hospital discharge, duration approx. 7-10 days)	No
Secondary	In-hospital Mortality		In-hospital period (until hospital discharge, duration approx. 7-10 days)	No