Phase 2
N=18
The Darbepoetin Alfa for Ischemic Surgical Complications (DISC) Dose Finding Trial
Spinal Ischemia · Stroke · Neuroprotection
Bottom Line
View on ClinicalTrials.gov: NCT00647998 ↗Enrolled (actual)
18
Serious AEs
38.9%
Results posted
Jan 2017
Primary outcome: Primary: Death or Neurologic Disability, Defined as an National Institutes of Health Stroke Scale (NIHSS)>4 or American Spinal Injury Association (ASIA) Lower Extermity Motor Score <25 — 1; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Darbepoetin alfa (Drug); Standard care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Death or Neurologic Disability, Defined as an National Institutes of Health Stroke Scale (NIHSS)>4 or American Spinal Injury Association (ASIA) Lower Extermity Motor Score <25 |
1; 3 | — |
| SECONDARY CSF S100beta |
214; 260 | — |
| SECONDARY Hemoglobin |
10.4; 9.5 | — |
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.
Eligibility 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 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)
Data sourced from ClinicalTrials.gov (NCT00647998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.