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NCT00647998 · ClinicalTrials.gov registry record · Phase 2
The Darbepoetin Alfa for Ischemic Surgical Complications (DISC) Dose Finding Trial
A Phase 2 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT00647998: Completed Phase 2 study, sponsored by University of Pennsylvania.
NCT00647998 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00647998, a Phase 2 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study 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.
Interventions
- OTHER Standard care
- DRUG Darbepoetin alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2008-01 |
| Est. Completion | 2010-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00647998
The ClinicalTrials.gov registry entry for NCT00647998 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard care is the first listed.
NCT00647998 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00647998 about?
NCT00647998 is a clinical study titled "The Darbepoetin Alfa for Ischemic Surgical Complications (DISC) Dose Finding Trial". 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 de...
What is the current status of trial NCT00647998?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2008-01. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00647998?
The interventions under investigation include: Standard care (OTHER), Darbepoetin alfa (DRUG).
Who is sponsoring clinical trial NCT00647998?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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