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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00647998
Other study ID # DISC-001
Secondary ID
Status Completed
Phase Phase 2
First received March 27, 2008
Last updated June 12, 2012
Start date January 2008
Est. completion date October 2010

Study information

Verified date June 2012
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date October 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States The Hospital of the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Death or neurologic disability, defined as an NIHSS>4 or ASIA<25 Day 30 Yes
Secondary CSF markers of ischemia 24 hours No
Secondary Hemoglobin Day 7, day 30 Yes
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