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Use of recombinant activated factor VII after paediatric cardiac surgery


To evaluate the opportunities of recombinant activated factor VII (rFVIIa) in pediatric patients with bleeding after cardiac surgery.


Since January 2003, 90 pediatric patients received rFVIIa for bleeding after cardiac surgery. Indications for rFVIIa were the following: prevention of bleeding after major surgery in newborns (arterial switch operation, radical correction of truncus arteriosus, Norwood's procedure) or bleeding rate 5 ml/kg/hour and more in older children – 75 patients (group A); severe tracheal bleeding in sepsis and multiple organ failure – six patients (group B); uncontrolled bleeding during total cardiopulmonary bypass with ECMO – nine patients (group C). Children's age was 2 days-18 years, body weight was 1.7–89 kg.

In group A the mean cardiopulmonary bypass time was 223 ± 29 min (108–423 min). Before rFVIIa was used the thrombocyte quantity increased up to 60 × 109/l, the ACT time was less 180 s and the body temperature was more than 35°C. FVIIa (120 μg/kg) was used 10–45 min after bypass. If needed, a repeated dose of 120 μg/kg was given after 1–1.5 hours (36 patients).

In group B severe tracheal bleeding developed in ventilated patients despite thrombocyte transfusions and 5000 UE/kg/hour aprotinin. rFVIIa was used in all patients twice (120 μg/kg).

In group C severe bleeding (8–42 ml/kg/hour) occurred during cardiopulmonary bypass with ECMO. Before rFVIIa administration the ACT was maintained between 180 and 200 s, the PLT quantity was not below 50 × 109/l and the aprotinin infusion rate was 10,000 UE/kg/hour. In all cases rFVIIa was used twice with a dose of 120 μg/kg.


In group A bleeding stoppage (<1 ml/kg/hour) was reached in 49 patients (65.3%) 40–75 min after FVIIa administration; in 17 cases (22.7%) the bleeding rate decreased to 1–4 ml/kg/hour (incomplete effectiveness) and stopped after 3–6 hours. In nine patents (12%) resternotomy was fulfilled because of ineffectiveness of rFVIIa therapy (bleeding rate 5 ml/kg/hour and more). Effectiveness of rFVIIa was higher in early administration of the drug (10–15 min after bypass). Following the hematology test, changes occurred: the APTT, INR and the SFMC concentration were decreased and the plasma FVIIa concentration was increased.

In group B life-threatening tracheal bleeding in mechanically ventilated septic patients with MOF was stopped in four of six cases (66.6%) during 30–75 min after rFVIIa administration. Both nonresponding patients were in severe uncorrectable respiratory/ metabolic acidosis before and during FVIIa infusion (pH 7.14/7.11, BE -12/-16 and pCO2 76/69 mmHg accordingly).

In group C the bleeding rate was decreased from 29 ± 12 ml/kg/hour to 4 ± 2.9 ml/kg/hour 2–5 hours after the second FVIIa infusion in six patients (66%). No cases of extracorporeal circuit/oxygenator thrombosis were occurred.

No significant adverse effects occurred in all groups.


rFVIIa effectively prevents and treats bleeding in pediatric cardiac surgery, including life-threatening tracheal bleeding in septic patients and large blood loss during prolonged cardiopulmonary bypass with ECMO. Further research is required to determine the indications and dose regimens in these groups of patients.

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Kharkin, A., Lobacheva, G., Bokeria, L. et al. Use of recombinant activated factor VII after paediatric cardiac surgery. Crit Care 10 (Suppl 1), P168 (2006).

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