The Darbepoetin Alfa for Ischemic Surgical Complications (DISC) Dose Finding Trial
Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
Participant gender:
Summary
Numerous neuroprotectants have been effective when given prior to ischemic stroke in animals,
yet they have all have failed when given after ischemic stroke in humans. A novel approach to
ischemic neuroprotection is needed. Many patients who undergo cardiac, vascular, and
neurosurgical procedures develop ischemic central nervous system (CNS) complications. These
high risk surgeries present a unique opportunity to administer neuroprotectant medication
prior to the injury, greatly increasing the likelihood that it will have a positive impact on
outcomes. Patients undergoing descending thoracic aortic (DTA) and thoracoabdominal aortic
(TAA) surgery have a particularly high rate of both brain and spine ischemia. In addition,
these surgeries require placement of a lumbar cerebrospinal fluid (CSF) drain, allowing
access to CSF in order to monitor markers of injury and penetration of medication into the
CNS. We are performing a pilot dose finding trial of prophylactic darbepoetin alfa, a
long-acting erythropoiesis medication with putative neuroprotectant properties, in patients
undergoing DTA and TAA surgery.