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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• Are men and women between the ages of 18 - 100 years old (inclusive)

• Require descending thoracic or thoracoabdominal aorta surgical repair

• Can provide informed consent

Exclusion Criteria:

• Have a traumatic aortic dissection

• Have a baseline NIHSS > 1 or modified Rankin Scale > 1

• Have a history of stroke or myocardial infarction within the past 30 days

• Have a preoperative hemoglobin < 9 or > 14

• Have a history of polycythemia vera or essential thrombocytosis

• Have a history of hematologic malignancy

• Have a history of arterial or venous thrombosis in the past three months

• Have uncontrolled hypertension

• Have active malignancy requiring treatment

• Are receiving hemodialysis

• Are currently using recombinant human erythropoietin or darbepoetin alfa, or have an expectation to require these medications within 30 days of surgery.

• Have a known allergy to recombinant human erythropoietin or darbepoetin alfa

• Are pregnant or breast-feeding. Women of childbearing potential must have a negative pregnancy test (urine pregnancy test or serum beta-HCG)