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Recombinant factor seven therapy for postoperative bleeding in neonatal and pediatric cardiac surgery
Hemant S Agarwal1, Jo E Bennett, Kevin B Churchwell
1Department of Pediatrics, Division of Pediatric Critical Care, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
Insights
Recombinant factor seven (rFVIIa) effectively treated severe bleeding in pediatric cardiac surgery patients, reducing drainage and transfusions. However, judicious use is crucial due to potential thrombotic complications.
Area of Science:
- Cardiology
- Hematology
- Pediatric Surgery
Background:
- Severe bleeding is a significant postoperative complication in pediatric cardiac surgery.
- Recombinant activated factor seven (rFVIIa) therapy is evaluated for efficacy and safety in this high-risk population.
Purpose of the Study:
- To assess the effectiveness of rFVIIa in managing severe bleeding post-pediatric cardiac surgery.
- To identify the safety profile and potential complications associated with rFVIIa use in these patients.
Main Methods:
- A retrospective case-control study compared patients treated with rFVIIa to those receiving only blood products.
- Analysis included chest tube drainage, blood product transfusion requirements, and coagulation parameters.
- Dose, frequency, and adverse events of rFVIIa were meticulously recorded.
Main Results:
- rFVIIa therapy showed a significant reduction in mediastinal bleeding and blood product transfusions.
- Twenty-three of 24 patients responded to rFVIIa, with notable decreases in chest tube output.
- Thrombotic complications occurred in 25% of patients, including ECMO circuit clots and limb ischemia.
Conclusions:
- rFVIIa is an effective treatment for severe bleeding in pediatric cardiac surgery patients when surgical bleeding is excluded.
- Careful consideration and judicious use are necessary in patients with multiple bleeding sites or pre-existing clots to mitigate thrombotic risks.
Background:
Severe bleeding is a major complication in the postoperative pediatric cardiac surgery patients. We evaluated the efficacy and safety of recombinant factor seven (rFVIIa) therapy in this patient population.
Methods:
A retrospective unmatched case-control study for the previous five years in a single institution was undertaken. Patients with severe bleeding treated with rFVIIa therapy (study group) were compared with patients treated with blood products only (control group) using analysis of variance. Mediastinal bleeding, blood products transfusion, and coagulation studies before and six hours after the first dose of rFVIIa therapy were analyzed using the Student paired t test. The dose, frequency, and side-effects of rFVIIa therapy were studied.
Results:
Forty-six patients with severe bleeding were studied. Twenty-three of 24 patients in the study group, including 12 patients placed on extracorporeal membrane oxygenation (ECMO), responded to rFVIIa therapy (mean dose 43 +/- 22.9 microg/kg/dose). There was significant reduction in chest tube drainage (from 52.3 +/- 36.1 mL/kg/hour to 18.8 +/- 20.9 mL/kg/hour, p = 0.0003) along with significant reduction of blood products transfusion (p < 0.001) in the study group patients as compared with control group patients. One patient who failed to respond had surgical bleeding. Two patients developed major thrombotic complications that included clots in the ECMO circuit and thrombosis at bleeding arterial line site resulting in limb ischemia. Four additional patients in the study group developed mediastinal clots. Overall, 25% of patients developed thrombosis after rFVIIa therapy.
Conclusions:
The rFVIIa therapy seems to be an effective treatment for severe bleeding in postoperative pediatric cardiac surgery patients in the absence of surgical bleeding. It must be judiciously used in patients bleeding from multiple sites or having preexistent clots in the ECMO circuit to prevent major thrombotic complications.
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