Coagulation abnormalities after pediatric open-heart surgery are complex and very often multifactorial. Besides the cardiopulmonary bypass (CPB), the congenital pathology and the coagulation tests during CPB, the younger age has been the most significant risk factor for bleeding and transfusion requirements. In children the volume of pump priming is much higher compared with the patient's circulating blood volume. For this reason the CPB tubing system is primed with packed red blood cells and fresh frozen plasma (FFP) to avoid excessive hemodilution and induced coagulopathy. While this is routinely performed in neonates and small infants, the routine priming of CPB system with FFP has been questioned in several randomized prospective studies in older infants. However, the results of these studies are conflicting. Moreover, they show methodological issues.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Mona Momeni
Brussels, Belgium
Postoperative bleeding (mL blood in the chest tubes). Significant postoperative bleeding is defined as a bleeding of > 5ml/kg/h in the first 6hours postoperatively.
The exact amount of blood loss in the postoperative period per kilogram weight of child.
Time frame: The first 6 hours postoperatively
Increased risk of of donor exposure intraoperatively and postoperatively.
The total number of different packs of allogeneic blood products administered per child.
Time frame: The first 6 hours postoperatively
Volume of transfused allogenic blood products (mL).
The total volume of allogeneic blood products per kilogram weight of child.
Time frame: The first 6 hours postoperatively
Comparison of Rotem and Multiplate between both groups.
The results of the point-of-care tests ROTEM and Multiplate will be compared between children in the Plasmalyte group and children in the Fresh Frozen Plasma group.
Time frame: The first 6 hours postoperatively
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