NCT02567786

Fresh Frozen Plasma and Plasmalyte ® for Priming Cardiopulmonary Bypass in Infants and Children

Comparison of Fresh Frozen Plasma and Plasmalyte ® for Priming Cardiopulmonary Bypass in Infants and Children Undergoing Open-heart Surgery: A Double-blind Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 2 Months – 70 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Congenital Heart Disease

Interventions

Type	Name	Description
PROCEDURE	Surgery with CPB
OTHER	Fresh Frozen Plasma
OTHER	Plasmalyte

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-06-30
• Completion: 2018-07-01
• First posted: 2015-10-05
• Last updated: 2018-12-05

Locations

1 site across 1 country: Belgium