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Published on: May 26, 2023
Comparison of Prothrombin Complex Concentrate with Activated Factor VII Use for Bleeding Following Cardiopulmonary
John W Benson1, Viktor Hraska2, John P Scott3,4
1Division of Pediatric Critical Care, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI, USA.
Insights
Prothrombin complex concentrate (PCC) demonstrated superior efficacy over activated recombinant factor VII (rFVIIa) in controlling bleeding after pediatric heart surgery, with similar safety profiles. Early PCC administration is suggested for managing post-cardiopulmonary bypass bleeding.
Area of Science:
- Pediatric Cardiology
- Hematology
- Surgical Hemostasis
Background:
- Bleeding complications after cardiopulmonary bypass (CPB) surgery in children with congenital heart disease require effective hemostatic management.
- Activated recombinant factor VII (rFVIIa) and prothrombin complex concentrate (PCC) are used to control such bleeding, but their comparative efficacy and safety are not fully established.
Purpose of the Study:
- To compare the efficacy and safety of rFVIIa versus PCC in pediatric patients undergoing CPB surgery.
- To evaluate hemostatic outcomes and thrombosis events in children treated with either rFVIIa or PCC for post-CPB bleeding.
Main Methods:
- Retrospective chart review of pediatric patients (0-18 years) with congenital heart disease who received either PCC or rFVIIa post-CPB.
- Primary efficacy endpoint: time from off-CPB to PICU admission. Primary safety endpoint: thrombosis within 30 days.
Main Results:
- PCC group showed significantly shorter operating room time (primary efficacy) and reduced need for packed red blood cells, chest tube output, and transfusions compared to the rFVIIa group.
- CPB time was longer and body temperatures lower in the rFVIIa group.
- No significant difference in 30-day thrombosis rates between PCC and rFVIIa groups.
Conclusions:
- PCC may be favored over rFVIIa for hemostasis in pediatric congenital heart disease patients post-CPB surgery.
- Both agents demonstrated similar safety outcomes, particularly regarding thrombosis.
- Early PCC administration appears beneficial for managing recalcitrant post-CPB bleeding.
Objective:
This study aims to compare the efficacy and safety of activated recombinant factor VII (rFVIIa) and prothrombin complex concentrate (PCC) in the treatment of bleeding complications following surgery requiring cardiopulmonary bypass (CPB) in children.
Design/Methods:
This is a retrospective chart review of a single institution comprising patients aged 0 to 18 years old with congenital heart disease. Patients must have received either PCC or rFVIIa after coming off CPB. Our primary efficacy endpoint is time in the operating room from off-CPB to pediatric intensive care unit admission. Our primary safety endpoint is thrombosis through 30 days.
Results:
Our primary efficacy outcome was significantly shorter in the PCC group compared with the rFVIIa group (P < .0001). Similarly, secondary efficacy outcomes of packed red blood cell administration, chest tube output, and transfusion exposures all significantly favored PCC administration. However, CPB time was significantly longer, and body temperatures were significantly lower, in the rFVIIa group. Safety outcomes, including our primary safety outcome of thrombosis through 30 days, were similar between the two groups.
Conclusion:
This study questions whether PCC could be favored over rFVIIa for hemostasis in children with congenital heart disease following CPB surgery. In addition, this study has found no difference when comparing PCC and rFVIIa in terms of safety outcomes, particularly thrombosis events. There are several limitations to this study due to the retrospective nature of the design and the differences between the two study groups. Despite the limitations, this study suggests that relatively early administration of PCC could be favored over delayed administration of rFVIIa to control recalcitrant post-CPB bleeding in the operating room.
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