A Pilot Study of Darbepoetin Alfa for Prophylactic Neuroprotection in Aortic Surgery
Neurocritical Care ,
Messe SR et al. – There were no significant effects of prophylactic darbepoetin alfa (DARB) on clinical outcome or CSF markers of neurologic injury in this pilot study, although all point estimates favored treatment. Descending aortic (DA) repair is a promising model of prophylactic neuroprotection.Methods
- The authors performed a prospective adaptive dose–finding trial of prophylactic DARB that terminated prematurely following publication of an erythropoietin stroke study showing possible harm.
- Enrollment halted before dose adjustments; nine patients each received 1mg/kg IV DARB immediately before surgery.
- A prospective cohort of nine untreated patients was subsequently obtained for comparison.
- The primary outcome of death or neurologic impairment at discharge occurred in 1/9 (11 %) DARB patients and 3/9 (33 %) controls (p=0.58).
- There were no statistical differences in changes of CSF biomarkers from baseline to 48h comparing DARB patients to controls: S100β, median 214 versus 260ng/ml (p=0.69); glial fibrillary acidic protein (GFAP), median 0.022 versus 0.58ng/ml (p=0.45).
- In patients with early perioperative neurologic ischemia, there were greater changes in CSF biomarkers, compared to those without ischemia: S100β, median 2301 versus 124ng/ml (p=0.04); GFAP, median 31.78 versus 0.31ng/ml (p=0.34).