Experience of NovoSeven administration in the management of severe haemorrhage following cardiac surgery of nonhaemophilic patients

Introduction

Severe bleeding in cardiac surgery is often difficult to manage. The aim of this study is clinical evaluation of efficacy of rFVIIa in the treatment of bleeding during and after cardiac surgery.

Patients and methods

rFVIIa (NovoSeven; NovoNordisk, Bagsvaerd Denmark) was used in 20 adult patients aged between 41 and 74 years, average BMI 25.48 ± 4.03, who underwent open heart surgery (five coronary artery bypass surgery, two valvular surgery, four double valve operations, five combining operations (coronary artery bypass with valve repair) and four surgery for aortic aneurisms) in 2004–2006. All patients had normal coagulation parameters before surgery. We used questionnaires for indications and effectiveness of treatment. We compared the amount of blood lost within 12 hours before and within 12 hours after giving rFVIIa, the dynamics of bleeding (assessed in ml/hour) before and after treatment. We also compared the haemoglobin level, haematocrit, number of platelets and laboratory coagulation profile parameters before treatment, 2 hours and 12 hours after treatment. NovoSeven was administered 5–49 minutes after neutralization of heparin with protamin sulfate. The dosage of rFVIIa was 39.23 ± 20.70 μg/kg (range 14.45–81.35). We used Student's t test for statistical analysis the laboratory data prior to and after rFVIIa.

Results

Indications for administration of the rFVIIa were considered when there was a postsurgical bleeding (exceeding 400 ml/hour) in the absence of surgical sources of the bleeding and lack of efficacy of the conventional hemostatic procedures. After administration of the first median dose (14.45–81.35 μg/kg) rFVIIa bleeding stopped in 11 patients. A marked decrease occurred in seven patients during 2 hours. The average blood lost within 12 hours before treatment was 2,510 ml and the average blood lost within 12 hours after treatment was 1,057 ml. The average dynamic of bleeding before treatment was 1,057 ml/hour and 87.90 ml/hour after treatment. The reduction in transfusion requirements was statistically significant.

Conclusion

NovoSeven produces a potent haemostatic effect in bleeding events refractory to the conventional therapy complicating the cardiosurgical interventions, and substantially decreases the demand for blood transfusion.