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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
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Bern, Schweiz, 3010
- University Hospital Bern
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Conventional Extracorporeal Circulation Technique
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This group of patients receives surgical aortic valve replacement using CECC.
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Experimentell: Minimized Extracorporeal Circulation Technique
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This group of patients receives surgical aortic valve replacement using MECC.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Total and interval-related cerebral microembolic load as measured by transcranial Doppler
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Cerebral complications, e.g. delirium and stroke as detected clinically
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Utredare
- Huvudutredare: Thierry Carrel, MD, PhD, Department of Cardiovascular Surgery
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 034/11
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