CLINICAL EVALUATION OF THE EFFECTIVENESS OF A LEUCO-LIPID FILTER APPLIED TO INTRA-OPERATIVE CARDIOTOMY SUCTION IN PATIENTS SUBJECTED TO EXTRACORPOREAL CIRCULATION.

During cardiac surgery blood loss from the intra-thoracic cavity is collected in a separate reservoir. After a clinical consideration based on the quantity of blood loss and the patient fluid balance, the blood collected in the separate suction reservoir is either returned in the circulation or discarded. The reinfusion of the collected blood can be done either through the study reservoir (leuco-lipid) or through the standard reservoir (control group).

1. Does filtration of the lipid particles reduce the inflammatory response to CPB?

2. Evaluation of the capacity of removing white blood cells from suction blood by cardiotomy filtration;

3. Research on possible adverse effects that the filter may have on blood rheology (increased haemolysis, drop in platelets, etc.);

4. Does the decrease of inflammatory response and a lower lipid micro emboli level have any clinical impact (in particular, the myocardial, pulmonary, renal and neurological functions are to be evaluated)?

Evaluation of micro emboli counts:

1. Emboli quantifier, EDAC.



Evaluation of lipid removal:

1. Triglycerides*;

2. Total Cholesterol*.



Evaluation of myocardial function:

1. Enzymes* (CK, CK-MB, LDH, Troponine T);

2. SvO2*;

3. Post operative use of inotropes or vasoconstrictors;

4. Arrythmia.



Evaluation of pulmonary function:

1. Time to extubation;

2. Prolonged intubation (>24 hours);

3. Postoperative PaO2/FiO2;

4. Reïntubation.



Evaluation of renal function:

1. Fluid balance;

2. Urea level* (mg/dl);

3. Creatinin level* (mg/dl);

4. Creatinin clearance* (ml/kg/min);

5. Urinary MA/cr**;

6. Diuresis.



Evaluation of the neurological function:

1. Incidence of any neurological complications.



Evaluation of hematological disturbances:

1. Haematocrit and hemoglobin*;

2. Platelet count*;

3. Fibrinogen*;

4. Requirement for transfusion (ml/component);

5. Reintervention for bleeding.



Evaluation of the inflammatory response and biocompatibility:

1. White blood cell count*;

2. Leukocyte formula*;

3. C3a**;

4. CRP*;

5. Neutrophil elastase.



Other parameters:

1. Hours of ICU stay;

2. Days of hospitalization;

3. Morbidity;

4. Mortality.



Time of evaluation:

* Pre-operative, admission on ICU, Evening ICU, POD1, POD2, POD3, POD4. (n7);

** Pre-operative, admission on ICU, POD1, POD4. (n4).

During Cardiopulmonary bypass, shed blood is stored in a seperate suction device. If the stored blood is clinically important, it needs to be added to the circulation. A clinical evaluation of a filter is to be evaluated. We compare 3 groups:

1. A leucolipid filtered group;

2. A standard filtered group;

3. A group where the blood is of no clinical importance, so it can be wasted.