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

Stroke Clinical Trial

— DISC  

Official title:

Phase 2 Dose Finding Trial of Prophylactic Darbepoetin Alfa to Improve Outcomes From Ischemic Complications of Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647998
• Other study ID #: DISC-001
• 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

• Neuroprotection
• Spinal Ischemia
• Stroke

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