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)
Aortic Valve Replacement Using Closed Extracorporeal Circuit. Minimized Versus Conventional Extracorporeal Circulation Technique: Qualitative Differences
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
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Bern, Schweiz, 3010
- University Hospital Bern
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: Conventional Extracorporeal Circulation Technique
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This group of patients receives surgical aortic valve replacement using CECC.
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Experimental: Minimized Extracorporeal Circulation Technique
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This group of patients receives surgical aortic valve replacement using MECC.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Total and interval-related cerebral microembolic load as measured by transcranial Doppler
Zeitfenster: Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs)
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Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Cerebral complications, e.g. delirium and stroke as detected clinically
Zeitfenster: In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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Redo surgery
Zeitfenster: In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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ICU length of stay
Zeitfenster: In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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Extubation time
Zeitfenster: In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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Thromboembolic complications
Zeitfenster: In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital infections
Zeitfenster: In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital Mortality
Zeitfenster: In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Thierry Carrel, MD, PhD, Department of Cardiovascular Surgery
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 034/11
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