The Darbepoetin Alfa for Ischemic Surgical Complications (DISC) Dose Finding Trial "DISC"

Completed

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Darbepoetin alfa Drug
    Other Names: Aranesp
    Intervention Desc: Patients will receive one IV injection of Darbepoetin alfa at doses ranging from 1mcg/kg to 6.5 mcg/kg prior to surgery

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Death or neurologic disability, defined as an NIHSS>4 or ASIA<25 Day 30 Yes
Secondary CSF markers of ischemia 24 hours No
Secondary Hemoglobin Day 7, day 30 Yes

Sponsors