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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Congenital Heart Disease

Treatments: Procedure: Surgery with CPB; Other: Fresh Frozen Plasma; Other: Plasmalyte

Study type: Interventional

Funder types: Other

Identifiers

NCT02567786

Plasma versus Plasmalyte

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 2 to 70 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children weighing between 7 and 15 kg and admitted to undergo open-heart surgery with CPB

Exclusion criteria

• Patients with preoperative coagulation abnormalities
• Parental refusal
• Emergency surgery
• Patients with preoperative renal or hepatic dysfunction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Fresh Frozen Plasma

Active Comparator group

Description:

The priming of the CPB oxygenator will be done with 15 ml/kg of FFP in addition to packed red blood cells.

Treatment:

Other: Fresh Frozen Plasma

Procedure: Surgery with CPB

Plasmalyte

Active Comparator group

Description:

The priming of the CPB oxygenator will be done with 15 ml/kg of Plasmalyte in addition to packed red blood cells.

Treatment:

Other: Plasmalyte

Procedure: Surgery with CPB