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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fresh Frozen Plasma | Active Comparator | The priming of the CPB oxygenator will be done with 15 ml/kg of FFP in addition to packed red blood cells. |
|
| Plasmalyte | Active Comparator | The priming of the CPB oxygenator will be done with 15 ml/kg of Plasmalyte in addition to packed red blood cells. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery with CPB | Procedure |
| ||
| Fresh Frozen Plasma |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mona Momeni, MD,PhD | Université Catholique de Louvain; Cliniques Universitaires Saint Luc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mona Momeni | Brussels | 1200 | Belgium |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| C048013 | Plasmalyte A |
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| Other |
|
| Plasmalyte | Other |
|
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 |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |