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

Not Applicable

Completed

• Conditions: Congenital Heart Disease
• Interventions: Procedure: Surgery with CPB; Other: Plasmalyte; Other: Fresh Frozen Plasma

• Registration Number: NCT02567786
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-29
• Study Start: 2015-10
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-05
• Primary Completion: 2018-06-30
• Study Completion: 2018-07
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-04
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plasmalyte	Plasmalyte	The priming of the CPB oxygenator will be done with 15 ml/kg of Plasmalyte in addition to packed red blood cells.
Fresh Frozen Plasma	Fresh Frozen Plasma	The priming of the CPB oxygenator will be done with 15 ml/kg of FFP in addition to packed red blood cells.
Fresh Frozen Plasma	Surgery with CPB	The priming of the CPB oxygenator will be done with 15 ml/kg of FFP in addition to packed red blood cells.
Plasmalyte	Surgery with CPB	The priming of the CPB oxygenator will be done with 15 ml/kg of Plasmalyte in addition to packed red blood cells.

Primary Outcome Measures

Name	Time	Method
Increased risk of of donor exposure intraoperatively and postoperatively.	The first 6 hours postoperatively	The total number of different packs of allogeneic blood products administered per child.
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 first 6 hours postoperatively	The exact amount of blood loss in the postoperative period per kilogram weight of child.

Secondary Outcome Measures

Name	Time	Method
Comparison of Rotem and Multiplate between both groups.	The first 6 hours postoperatively	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.
Volume of transfused allogenic blood products (mL).	The first 6 hours postoperatively	The total volume of allogeneic blood products per kilogram weight of child.

Trial Locations

Locations (1)

Mona Momeni; 🇧🇪 Brussels, Belgium