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NCT Number: 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

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Extracorporeal Circulation Heart Diseases Heart Valve Diseases Intracranial Embolism Intracranial Embolism and Thrombosis Nervous System Diseases Thromboembolism Vascular Diseases Ventricular Outflow Obstruction

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Bern

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Minimized Extracorporeal Circulation (MECC)

Procedure

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

Conventional Extracorporeal Circulation (CECC)

Procedure

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

Primary outcomes

  1. 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 outcomes

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

    Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)

  2. Redo surgery

    Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)

  3. ICU length of stay

    Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)

  4. Extubation time

    Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)

  5. Thromboembolic complications

    Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)

  6. In-hospital infections

    Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)

  7. In-hospital Mortality

    Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Acronym: AKE-MECC

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Dec 4, 2014
Registry last updated
Jun 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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