Administration off label of recombinant factor-VIIa (rFVIIa) to patients with blunt or penetrating brain injury without coagulopathy

• Published in: Acta neurochirurgica 2008-07, Vol.150 (7), p.663-668
• Main Authors: Zaaroor, M., Soustiel, J. F., Brenner, B., Bar-Lavie, Y., Martinowitz, U., Levi, L.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Blood Coagulation Disorders; Brain Injuries - drug therapy; Brain Injuries - surgery; Child; Child, Preschool; Clinical Article; Disease Progression; Drug Administration Schedule; Drug Labeling; Factor VIIa - administration & dosage; Factor VIIa - therapeutic use; Head Injuries, Penetrating - drug therapy; Head Injuries, Penetrating - mortality; Head Injuries, Penetrating - surgery; Hemostatic Techniques; Humans; Interventional Radiology; Medicine; Medicine & Public Health; Middle Aged; Minimally Invasive Surgery; Neurology; Neuroradiology; Neurosurgery; Neurosurgical Procedures; Recombinant Proteins - administration & dosage; Recombinant Proteins - therapeutic use; Risk Assessment; Surgical Orthopedics; Trauma Severity Indices; Wounds, Nonpenetrating - drug therapy; Wounds, Nonpenetrating - surgery
• ISSN: 0001-6268; 0942-0940
• DOI: 10.1007/s00701-008-1593-y

Summary Traumatic brain contusions may increase in size over time or may develop at a delay after injury. This may lead to neurological deterioration, long term morbidity or even death. Coagulation disorders after injury can contribute to progression of haemorrhage. Recombinant activated factor VII (rFVIIa) was used in 12 patients with a severe head injury who had no systemic coagulopathy but who were considered to be at risk of progression of their intracranial lesion. Twelve consecutive patients suffering from life-threatening acute head injuries from blunt (3 cases) and penetrating mechanisms were given with rFVIIa, either to prevent the expected development of brain contusion or to assist in bleeding control during surgery. In 11 patients, rFVIIa was given by the attending neurosurgeon. Two of the patients died of their severe penetrating injuries one of whom had severe vasospasm 2 days after administration of rFVIIa. The other 11 patients did not appear to suffer any treatment-related adverse effects. When the drug was given prophylactically to prevent brain resection (6 cases) or to limit the need for widening resection (5 cases), marked control was achieved in seven cases, and a lesser effect was observed in the other 4 cases. We conclude that, in a small and highly individually selected series of patients with severe head injury, the administration of rFVIIa did not lead to adverse effects. Although the majority of patients were considered to be at high risk of progression of their lesions, this occurred in only one. The early use of rFVIIa in head injured patients without systemic coagulopathy may reduce the occurrence of enlargement of contusions, the requirement of further operation, and adverse outcome. Prospective randomised controlled studies are required to investigate this.