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NCT00626574 · ClinicalTrials.gov registry record · Phase 4
Treating Patients With Aneurysmal SubArachnoid Hemorrhage (SAH) With Epoetin Alfa
A Phase 4 study, sponsored by University of South Florida.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT00626574: Clinical Trial Phase 4 study, sponsored by University of South Florida.
NCT00626574 is a Phase 4 study that was terminated before completion, run by University of South Florida. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00626574, a Phase 4 study, was terminated before completion, sponsored by University of South Florida.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is a prospective, randomized, double-blinded, placebo controlled pilot safety study that will enroll a total of twenty subjects. Subjects will be adults (30-75) who have sustained a SAH secondary to cerebral aneurysm rupture and who present with minimal neurological symptoms. All subjects will have a Hemoglobin less than or equal to 12 g/dL within 24 hours prior to study entry and undergo operative aneurismal clipping. Subjects will be randomized into two groups, ten subjects receiving the drug and ten subjects receiving the placebo. The subjects will receive three intravenous injections of study drug or placebo, once before undergoing operative aneurysmal clipping (study Day 1) and again for two additional days (study Day 2 and study Day 3). There are 3 phases to this trial: Screening Phase - patients will present with Subarachnoid hemorrhage (SAH) and prepped for surgery within 36 hours Treatment Phase - first pre-operative dose before surgery (Study Day 1), post-operative (Study Days 2 and 3) Follow-up Phase- Study Day 4 through discharge, 6-7 week follow-up Primary Objective: To determine the safety of administering intravenous doses of Procrit® once daily for three consecutive days to patients with aneurysmal SAH before and after vascular clipping by comparing the incidence of thrombotic events, hemoglobin and 6-7 week mortality between the Procrit® and placebo groups. Secondary Objectives: To determine if administration of Procrit® prior to aneurysm clipping reduces the incidence of vasospasm following a SAH event treated by vascular clipping. To determine if Procrit® administration prior to aneurysm clipping in patients with Aneurysmal SAH will improve neurological assessment scores in the post-SAH/post-clipping time period. To determine the feasibility of organizing a larger, randomized study to explore the neuroprotective effect of Procrit® in patients with Aneurysmal SubArachnoid Hemorrhage (SAH) when Procrit® is administered prior to surgical clipp
Primary Outcome
Number of adverse events
Interventions
- DRUG Saline
- DRUG Epoetin alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2007-07 |
| Est. Completion | 2009-02 |
| Phase | Phase 4 |
Why NCT00626574 stopped before completion
NCT00626574 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT00626574 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00626574 about?
NCT00626574 is a clinical study titled "Treating Patients With Aneurysmal SubArachnoid Hemorrhage (SAH) With Epoetin Alfa". This is a prospective, randomized, double-blinded, placebo controlled pilot safety study that will enroll a total of twenty subjects. Subjects will be adults (30-75) who have sustained a SAH secondary to cerebral aneurysm rupture and who present with minimal neurological symptoms. All subjects will ...
What is the current status of trial NCT00626574?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2007-07. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00626574?
The interventions under investigation include: Saline (DRUG), Epoetin alfa (DRUG).
Who is sponsoring clinical trial NCT00626574?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00626574's enrollment target sits among peer trials
3 1995th of 2000 higher than 3 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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