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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Procedure: Surgery with CPB
* Other: Fresh Frozen Plasma
* Other: Plasmalyte


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 70 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |