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Use of recombinant activated factor VII in intractable bleeding during pediatric neurosurgical procedures.
Uhrig L et al:
Journal: Pediatr Crit Care Med 8(6):576-579, 2007. 22 References
Reprint: Pediatric Anesthesiology and Neuro Critical Care Unit, Faculté de Médecine René Descartes Paris 5, Centre Hospitalier Universitaire Necker-Enfants Malades, Paris, France (PG Meyer, MD)
Faculty Disclosure: Abstracted by T. Tilton, who has nothing to disclose.

Blood loss in children undergoing neurosurgical procedures can be unpredictable with massive loss potentially resulting in secondary coagulopathy and difficulty in controlling subsequent bleeding. Conventional treatment consists of packed red blood cells and fresh frozen plasma but these may not be sufficient. Recombinant activated factor VII (rFVIIa) has successfully treated bleeding for patients with hemophilia. It is suggested that high-dose rFVIIa can enhance hemostasis at the site of the injury, without inducing systematic activation of the coagulation cascade and resulting in massively increased rFVIIa levels leading to faster and higher thrombin generation. The authors report 4 cases of the off-label use of rFVIIa.

The 4 patients were described as follows: a 22-month-old boy (10 kg) with severe head trauma (extensive left frontal fracture and contusion and acute subdural hematoma with mass effect) due to a fall from a second-story window; a 4-month-old boy (6 kg 600) for skull vault reconstruction for sagittal craniosynostosis; a 26-month-old girl (10 kg) with a complex craniofacial deformity (related to Pfeiffer syndrome) for extensive skull vault reconstruction; and a 21-month-old girl (10 kg 900) with ataxia and symptoms of acute intracranial hypertension with hydrocephalus due to a large malignant tumor expanding into the 3rd ventricle presenting for emergency resection due to rapid clinical deterioration.

All 4 patients experienced extensive blood loss and hemodynamic instability unresponsive to massive transfusions. All patients received rFVIIa 100 mcg/kg in 1 or 2 doses intravenously with a rapid response resulting in decreased bleeding and hemodynamic stability. Recovery was satisfactory for patient 1; patient 2 experienced a good recovery but with transient general tonic-clonic seizures controlled with phenobarbital and phenytoin; patient 3 made a good recovery; and patient 4 developed intractable brain swelling and remained in a persistent vegetative state for 1 month after surgery. No side effects were noted.

It is concluded that rFVIIa (100 mcg/kg IV administered over 2-5 min) rapidly promotes hemostasis in low weight pediatric neurosurgical patients who are experiencing massive, uncontrolled hemorrhage.