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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 July 2016 |
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Main ID: |
NCT02308566 |
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Date of registration:
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02/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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 |
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Scientific title:
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Aortic Valve Replacement Using Closed Extracorporeal Circuit. Minimized Versus Conventional Extracorporeal Circulation Technique: Qualitative Differences |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02308566 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Thierry Carrel, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Cardiovascular Surgery |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Extracorporeal Circulation
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Aortic Valve Stenosis
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Intervention(s)
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Procedure: Conventional Extracorporeal Circulation (CECC)
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Procedure: Minimized Extracorporeal Circulation (MECC)
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Primary Outcome(s)
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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)]
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Secondary Outcome(s)
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Extubation time
[Time Frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)]
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ICU length of stay
[Time Frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)]
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Redo surgery
[Time Frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)]
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Thromboembolic complications
[Time Frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)]
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In-hospital Mortality
[Time Frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)]
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In-hospital infections
[Time Frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)]
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Cerebral complications, e.g. delirium and stroke as detected clinically
[Time Frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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