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

Completed · Phase 2

Conditions studied: Spinal Ischemia, Stroke, Neuroprotection

In brief

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.

Key facts

Study ID

NCT00647998

Run by

University of Pennsylvania

People needed

18

Starts

2008-01-01

Expected to finish

2010-10-01

Last updated by the study team

2017-06-05

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• The Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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