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

Clinical evaluation after leukocyte and lipid filtration in the cardiotomy reservoir of the mediastinal aspirated blood.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28768

Enrollment

150

Registered

2011-01-13

Start date

2011-01-21

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Three groups of 50 patients, scheduled for myocardial revascularization surgery with the use of cardiopulmonary bypass.

Interventions

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 filte

2. A standard filtered group

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

Eligibility

Inclusion criteria

Inclusion criteria: All patients admitted for coronary artery bypass grafting surgery. A clinical consideration will be taken over the patient’s blood loss. If blood loss is low, it will be discarded. If blood loss is significant for patients blood balance, the volume will be added to the circulation. The filter used for filtration will contain a leuco-lipid filter or contain a standard filter.

Exclusion criteria

Exclusion criteria: 1. Repeated surgery; 2. Requirement for dialysis; 3. Urgencies; 4. Emergencies; 5. Previous major cerebro-vascular insults; 6. The use of intra aortic balloon pump.

Design outcomes

Primary

Measure	Time frame
Clinical evaluation of a filter for the removal of lipid particles and leukocytes from mediastinal suctioned blood during cardiopulmonary bypass (CPB).	—

Secondary

Measure	Time frame
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)?	—

Measure

Time frame

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)?

—

Contacts

Public ContactVeerle Mossevelde, van

Laarbeeklaan 101

veerle.vanmossevelde@uzbrussel.be+32 (0)2 4763134

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)