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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven Messe, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00647998
First received: March 27, 2008
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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
Stroke
Neuroprotection
Drug: Darbepoetin alfa
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group 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: Day 30 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • CSF markers of ischemia [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Hemoglobin [ Time Frame: Day 7, day 30 ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: January 2008
Study Completion Date: October 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647998

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

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven Messe, Assistant professor of neurology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00647998     History of Changes
Other Study ID Numbers: DISC-001
Study First Received: March 27, 2008
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Surgical complications
Spinal ischemia
Stroke
Neuroprotection

Additional relevant MeSH terms:
Ischemia
Stroke
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014