neurocognitive deficit Stroke
Conditions
Interventions
One group of patients will undergo aortic valve replacement with the minimized
extracorporeal circulation (MECC) and the other group of patient will be
treated with the CECC.
Minimized Extra Corpo
Jostra) and a membrane oxygenator (Quadox HE
Jostra). The Venous line
is connected to the centrifugal pump via a venousbubble trap (VBT 160). All
components are Bioline coated ( Jostra). Priming volume of the system is 700 ml
of NaCl 0,9 %( t
Cobe). Anticogulationis attained by
administration of 150 IU/KG heparin to achieve an activated clotting time of
longer than 300 seconds. The left ventricle is vented via a vent in the
pulmonary ar
Jostra) , a venous reservoir
(BMR 1900G
Jostra), a cardiotomy reservoir ( Quadrox BE-AC2811
Jostra), and
Rehau Bioline-coated tubing ( Maquet/Jostra). The pump is primed with 1600 mL.
Myocardial protection is performed by using a modified Calafiori technique
(blood cardioplegia every 15 -
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.The patient must be between 18-80 years of age. 2.Patients scheduled for elective aortic valve surgery or combined coronary with aortic valve surgery 3.The patient is mentally able and willing to give informed consent.
Exclusion criteria
Exclusion criteria: 1. Emergency operation 2. Active endocarditis 3. Double valve procedure. 4. Operation on the aortic root. 5. Very poor left ventricular function (EF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point for the study will be the number of high intensity transient signals (HITS) as detected by the TCD during the procedure. Adjacent to HITS the consumption of blood products will be the main study parameter | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective(s): To evaluate the impact of the minimized extracorporeal circulation (MECC) on : Quality of life ( SF 12 ) Cerebrovascular accident Transient ischemic attack Myocardial infarction Mortality Bleeding Coagulation Transfusion Inflammatory response Re-admission SDF-imaging Neuropsychological functioning MRI brain Organ damage ( Cardiac, Renal, Intestinal, Liver) Cerebrale Oxymetrie Fluidbalance | — |
Countries
Netherlands
Outcome results
None listed