Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Steven Messe, University of Pennsylvania Identifier:
First received: March 27, 2008
Last updated: November 3, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Spinal Ischemia
Drug: Darbepoetin alfa
Other: Standard care
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Dose Finding Trial of Prophylactic Darbepoetin Alfa to Improve Outcomes From Ischemic Complications of Surgery

Resource links provided by NLM:

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Death or Neurologic Disability, Defined as an NIHSS>4 or ASIA<25 [ Time Frame: Discharge ]

Secondary Outcome Measures:
  • CSF Markers of Ischemia [ Time Frame: 24 hours ]
  • Hemoglobin [ Time Frame: Day 7, day 30 ]

Enrollment: 18
Study Start Date: January 2008
Study Completion Date: October 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Darbepoetin
Patients received 1mg/kg IV Darbepoetin immediately prior to surgery
Drug: Darbepoetin alfa
Patients will receive one IV injection of Darbepoetin alfa at doses ranging from 1mcg/kg to 6.5 mcg/kg prior to surgery
Other Name: Aranesp
Other: Standard care
Placebo Comparator: Standard care
No Darbepoetin
Other: Standard care


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00647998

United States, Pennsylvania
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Steven Messe, Associate professor of neurology, University of Pennsylvania Identifier: NCT00647998     History of Changes
Other Study ID Numbers: DISC-001
Study First Received: March 27, 2008
Results First Received: November 3, 2016
Last Updated: November 3, 2016

Keywords provided by University of Pennsylvania:
Surgical complications
Spinal ischemia

Additional relevant MeSH terms:
Pathologic Processes
Darbepoetin alfa
Hematinics processed this record on May 25, 2017