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

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 Overview

• Status: Completed
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Other: Plasmalyte; Procedure: Surgery with CPB; Other: Fresh Frozen Plasma

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Mona Momeni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Surgery with CPB; Other: Fresh Frozen Plasma
Active Comparator: Plasmalyte; The priming of the CPB oxygenator will be done with 15 ml/kg of Plasmalyte in addition to packed red blood cells.	Other: Plasmalyte; Procedure: Surgery with CPB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	The first 6 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of transfused allogenic blood products (mL).	The total volume of allogeneic blood products per kilogram weight of child.	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.	The first 6 hours postoperatively

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Mona Momeni, MD,PhD, Université Catholique de Louvain; Cliniques Universitaires Saint Luc

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: October 2, 2015
• First Posted (Estimate): October 5, 2015

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital; Pharmaceutical Solutions; Ophthalmic Solutions; Plasma-lyte 148
• Other Study ID Numbers: Plasma versus Plasmalyte