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Safe use of recombinant activated factor VIIa for recalcitrant postoperative haemorrhage in cardiac surgery

Department of Cardiothoracic Surgery, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia

*Corresponding author. Suite 28, Private Medical Centre, Royal Melbourne Hospital, Victoria 3050, Australia. Tel.: +93427000; fax: +93475258.

E-mail address: james.Tatoulis{at}mh.org.au (J. Tatoulis).

The aim of this case series is to review the effect of recombinant activated factor VIIa (rFVIIa) on refractory haemorrhage, despite aggressive treatment with conventional blood products and medications at our institution. All patients undergoing cardiac surgery who received rFVIIa as rescue therapy for persistent uncontrollable haemorrhage were studied. We examined coagulation immediately before and after rFVIIa was given; international normalized ratio (INR), activated partial thromboplastin (APTT) fibrinogen and platelet levels, in addition to the use of red cell and non-red cell blood products, morbidity and mortality. Thirty patients (0.6%) received 31 doses of rFVIIa for bleeding refractory to conventional treatment. Twenty received rFVIIa in theatre after primary surgery, three after re-exploration and eight in the intensive care unit (ICU). Hospital mortality was 6.5% (2/30) and there were no documented thromboembolic phenomena. There was significant reduction in red blood cell and product transfusion before and after rFVIIa administration (P<0.001). There was significant correction in coagulation parameters after rFVIIa. Recombinant FVIIa appears to be safe, and is effective in reducing red blood cell and product transfusion requirements and may impact on early and late outcomes in this small complex subgroup of patients.

Key Words: Novoseven; Recombinant activated factor seven; Refractory bleeding