search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number8931
- NTR NumberNTR2696
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jan-2011
- Secondary IDs2010/258 MEC UZ Brussel
- Public TitleCLINICAL EVALUATION OF THE EFFECTIVENESS OF A LEUCO-LIPID FILTER APPLIED TO INTRA-OPERATIVE CARDIOTOMY SUCTION IN PATIENTS SUBJECTED TO EXTRACORPOREAL CIRCULATION.
- Scientific TitleClinical evaluation after leukocyte and lipid filtration in the cardiotomy reservoir of the mediastinal aspirated blood.
- ACRONYM
- hypothesis1. 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)?
- Healt Condition(s) or Problem(s) studiedCardiopulmonary Bypass (CPB), Myocardial revascularization surgery
- Inclusion criteriaAll patients admitted for coronary artery bypass grafting surgery. A clinical consideration will be taken over the patientís 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 criteria1. Repeated surgery;
2. Requirement for dialysis;
3. Urgencies;
4. Emergencies;
5. Previous major cerebro-vascular insults;
6. The use of intra aortic balloon pump.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 21-jan-2011
- planned closingdate21-jan-2013
- Target number of participants150
- InterventionsDuring 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.
- Primary outcomeClinical evaluation of a filter for the removal of lipid particles and leukocytes from mediastinal suctioned blood during cardiopulmonary bypass (CPB).
- Secondary outcome1. 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)?
- TimepointsEvaluation 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. ReÔntubation.

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).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Veerle Mossevelde, van
- CONTACT for SCIENTIFIC QUERIES Kurt Staessens
- Sponsor/Initiator Universitair Ziekenhuis Brussel
- Funding
(Source(s) of Monetary or Material Support)
Hartcenter University Hospital Brussels
- PublicationsN/A
- Brief summaryDuring 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).
- Main changes (audit trail)
- RECORD13-jan-2011 - 18-mei-2011


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl