Experience of recombinant activated factor VII (NovoSeven) in the operating theatre and intensive care unit for the management of intracranial bleeding in nonhaemophilic patients.

Objective: Intracranial haemorrhage (ICH) is associated with high morbidity and mortality. Our aim was to explore the use of recombinant activated factor VII (rFVIIa NovoSeven Novo Nordisk, A/S, Bagsvaerd, Denmark) for the management of ICH in the operating theater and intensive care unit.

Patients And Methods: We reviewed all the records of nonhaemophilic patients entered into the haemostasis.com database who received rFVIIa for ICH.

Results: Sixteen suitable patients were identified (mean age: 23.3 years; range: 1-58 years). The total dose of rFVIIa administered ranged from 31 to 270 microg/kg. Indications were stabilization of ICH (n=6), control of peri- or post-operative haemorrhage associated with neurosurgical procedures (n=8), or correction of coagulopathy prior to neurosurgical intervention (n=2). The majority (13/16 [81.25%]) required one dose of rFVIIa. A clinical effect (stabilization of bleed, reduction of peri- or post-operative haemorrhage, or prevention of excessive blood loss during neurosurgery) was seen in 14/16 (87.5%) patients. Some improvement in coagulation status was noted. No thromboembolic events were reported. One patient experienced massive elevation of D-dimer levels-an effect possibly due to rFVIIa. Two patients suffered adverse events unrelated to rFVIIa. Six deaths occurred, all attributable to underlying brain injury.

Conclusion: This observational study suggests that rFVIIa is of value for the management of ICH in nonhaemophilic patients secondary to a range of aetiologies. These findings justify further investigation.