|- candidate number||5395|
|- NTR Number||NTR1691|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-mrt-2009|
|- Secondary IDs||P07-168 METC LUMC|
|- Public Title||Restrictive red blood cell policy in postoperative cardiac surgery patients.|
|- Scientific Title||Restrictive red blood cell policy in postoperative cardiac surgery patients.|
|- hypothesis||Reduction in red blood cell transfusions is associated with a reduction morbidity, expressed as ventilator days, length of PICU and hospital stay, nosocomial infections.|
|- Healt Condition(s) or Problem(s) studied||Cardiovascular system, Children, Post operative|
|- Inclusion criteria||Pediatric patients with a non-cyanotic congenital heart defect (>3 kg, >6 weeks and < 6 years) undergoing cardiac surgery.|
|- Exclusion criteria||1. Neonates;|
2. Underlying hematological disease (hemoglobinopathy);
3. Patients participating in another study that may interfere with this study.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-mrt-2009|
|- planned closingdate||1-jan-2011|
|- Target number of participants||100|
|- Interventions||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.|
|- Primary outcome||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).|
|- Secondary outcome||1. Can continuous venous saturation monitoring guide the transfusion policy?|
2. How usefull are continuous oxygen saturation measurements?
3. What is the role of mannose binding lectin (MBL) and the development of nosocomial infections in transfused pediatric postoperative cardiac surgery patients.
|- Timepoints||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).|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||kinderarts-intensivist D.A.H. Gast-Bakker, de|
|- CONTACT for SCIENTIFIC QUERIES||kinderarts-intensivist D.A.H. Gast-Bakker, de|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Sanquin Blood Bank (Stichting Sanquin Bloedvoorziening)|
(Source(s) of Monetary or Material Support)
|Sanquin Bloodbank Amsterdam, Leiden University Medical Center (LUMC)|
|- Brief summary||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. |
|- Main changes (audit trail)|
|- RECORD||1-mrt-2009 - 14-sep-2009|