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.


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.


CONCLUSIONS
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.
Felfernig
Michael
M
Department of Anaesthesia and General Intensive Care, Medical University Vienna, Waehringerguertel 18-20, 1090 Vienna, Austria. felfernigMD@doctors.org.uk
Huepfl
Michael
M
D000293:Adolescent; D000328:Adult; D000925:Anticoagulants / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D005167:Factor VII / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007223:Infant; D007362:Intensive Care Units; D020300:Intracranial Hemorrhages / Q000188:drug therapy* / Q000401:mortality / Q000517:prevention & control; D007431:Intraoperative Complications / Q000188:drug therapy* / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D019635:Neurosurgical Procedures; D011183:Postoperative Complications / Q000188:drug therapy / Q000401:mortality / Q000517:prevention & control; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies; D016896:Treatment Outcome
D000925:Anticoagulants; D011994:Recombinant Proteins; D005167:Factor VII