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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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). 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.
Primary Outcome
The NIHSS is a validated quasi-ordinal measure of stroke severity. An NIHSS \>4 is generally considered moderate or severe. The ASIA Lower Extremity Motor Score is a cumulative total of assessments of strength in 5 muscles in each leg, using the Medical Research Council 0-5 stroke score. ASIA score \< 25 is associated with impaired ambulation.
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 |
What the finished NCT00647998 record still lists
NCT00647998 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard care is the first listed.
NCT00647998 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00647998's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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