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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567786
• Other study ID #: Plasma versus Plasmalyte
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: July 2018

Study information

• Verified date: December 2018
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 70 Months

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Diseases

Intervention

Procedure:
• Surgery with CPB

Other:
• Fresh Frozen Plasma

• Plasmalyte

Locations

Country	Name	City	State
Belgium	Mona Momeni	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Volume of transfused allogenic blood products (mL).	The total volume of allogeneic blood products per kilogram weight of child.	The first 6 hours postoperatively
Secondary	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