Reduction in red blood cell transfusions is associated with a reduction morbidity, expressed as ventilator days, length of PICU and hospital stay, nosocomial infections.
ID
Bron
Verkorte titel
Aandoening
pediatric postoperative cardiac surgery patients, red blood cell transfusion, morbidity, nososcomial infection, MBL, venous saturation
pediatrische postoperatieve cardiochirurgische patienten, erytrocytentransfusie, morbiditeit, nosocomiale infecties, MBL, veneuze saturatie
Ondersteuning
IC centrum, LUMC, Prof. Dr. L.P.H.J. Aarts
Sanquin bloedbank zuid-west Nederland (Dr.L.M.G. van de Watering)
Sanquin bloedbank zuid-west Nederland, Dr.L.M.G. van de Watering
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Reduction in red blood cell transfusion and the morbidity related to the transfusion (expressed as ventilator days, length of PICU and hospital stay, nosocomial infections).
Achtergrond van het onderzoek
The practise of red blood cell transfusion in critically ill children is common practise. Treatment of anemia is the mean rationale for transfusing children after cardiac surgery. It is generally beleived that thay have a lower margin of safety for tolerance of low hemoglobin and that oxygen consumption improves when they are transfused. However this concept has never been proven. Additionally a well defined threshold value when to transfuse is unavailable. Recents studies in adults and children show increasing morbidity related to transfusion requirements. No adverse outcome was observed in a recent study in stable critically children when restricting the transfusion policy, accepting a lower threshold seems appropriate. Continuous oxygen saturation monitoring may be helpfull in the decision making of whether a red blood cell transfusion is required.
Doel van het onderzoek
Reduction in red blood cell transfusions is associated with a reduction morbidity, expressed as ventilator days, length of PICU and hospital stay, nosocomial infections.
Onderzoeksopzet
The study starts at the operating room and patients are follwed for 28 days.
Continuous venous saturation measurement is maximum 72 hours, cerebral oxygen saturation (NIRS) 24 hours, all other monitoring is according to the standard protocol.
Bloodsamples are according to the standard protocol with two additional samples (after induction at te OR, after admittance on PICU).
Onderzoeksproduct en/of interventie
After inclusion the patients are randomised in two groups (restrictive and liberal transfusion policy). The transfusion triggerpoint for the restrice group is set at a hemoglobin of 5 mmol/L versus 6,8 in the liberal group.
In both groups patients are treated according to the standard protocol with all the minitoring they require postoperatively. Additionally continuous venous saturation is measured during maximum 72 hours, the storage time of the red blood cell is registered and mannose binding lectine is measured twice.
Publiek
Postbus 9600
D.A.H. Gast-Bakker, de
Intensive Care Kinderen
kamer J4-31
Leiden 2300 RC
The Netherlands
d.h.Gast-Bakker_de@lumc.nl
Wetenschappelijk
Postbus 9600
D.A.H. Gast-Bakker, de
Intensive Care Kinderen
kamer J4-31
Leiden 2300 RC
The Netherlands
d.h.Gast-Bakker_de@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Pediatric patients with a non-cyanotic congenital heart defect (>3 kg, >6 weeks and < 6 years) undergoing cardiac surgery.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Neonates;
2. Underlying hematological disease (hemoglobinopathy);
3. Patients participating in another study that may interfere with this study.
Opzet
Deelname
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Register | ID |
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