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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)

29. juni 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Schweiz
      • Bern, Schweiz, 3010
        • University Hospital Bern

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Conventional Extracorporeal Circulation Technique
Procedure: Conventional Extracorporeal Circulation (CECC)
This group of patients receives surgical aortic valve replacement using CECC.
Eksperimentel: Minimized Extracorporeal Circulation Technique
Procedure: Minimized Extracorporeal Circulation (MECC)
This group of patients receives surgical aortic valve replacement using MECC.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tidsramme
Cerebral complications, e.g. delirium and stroke as detected clinically
Tidsramme: In-hospital period (until hospital discharge, duration approx. 7-10 days)
In-hospital period (until hospital discharge, duration approx. 7-10 days)
Redo surgery
Tidsramme: 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
Tidsramme: In-hospital period (until hospital discharge, duration approx. 7-10 days)
In-hospital period (until hospital discharge, duration approx. 7-10 days)
Extubation time
Tidsramme: In-hospital period (until hospital discharge, duration approx. 7-10 days)
In-hospital period (until hospital discharge, duration approx. 7-10 days)
Thromboembolic complications
Tidsramme: 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
Tidsramme: 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
Tidsramme: In-hospital period (until hospital discharge, duration approx. 7-10 days)
In-hospital period (until hospital discharge, duration approx. 7-10 days)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital Inselspital, Berne

Efterforskere

  • Ledende efterforsker: Thierry Carrel, MD, PhD, Department of Cardiovascular Surgery

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2011

Primær færdiggørelse (Faktiske)

1. marts 2016

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

2. december 2014

Først indsendt, der opfyldte QC-kriterier

2. december 2014

Først opslået (Skøn)

4. december 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. juni 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 034/11

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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