Status:
COMPLETED
The Darbepoetin Alfa for Ischemic Surgical Complications (DISC) Dose Finding Trial
Lead Sponsor:
University of Pennsylvania
Conditions:
Spinal Ischemia
Stroke
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief 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 neu...
Detailed 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 neu...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00647998
Start Date
January 1 2008
End Date
October 1 2010
Last Update
June 5 2017
Active Locations (1)
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1
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104