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NCT00990509 · ClinicalTrials.gov registry record · Phase 2
Albumin for Intracerebral Hemorrhage Intervention
A Phase 2 study, sponsored by Georgetown University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT00990509 is a Phase 2 study that was terminated before completion, run by Georgetown University. The registered enrollment target is 14 participants.
The verdict
NCT00990509, a Phase 2 study, was terminated before completion, sponsored by Georgetown University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to find out what effects, good and bad, the medication Albumin has on subjects who have experienced a type of stroke known as an intracerebral hemorrhage (ICH). An ICH is when spontaneous bleeding into the brain occurs due to fragile blood vessels. This research is being done because currently there is no effective treatment for ICH. However, study investigators believe that Albumin, the medication being tested in this study, is safe and may help improve patient recovery from ICH over time. Subjects will be enrolled in the study for a total of 90 days. Following enrollment, subjects will be randomized to receive 3 daily injections of either Albumin or Placebo (liquid with no drug), and will receive 3 brain MRI scans (with and without contrast), as described below. All subjects will be monitored continuously through 96 hours after enrollment (5 days) in the Georgetown ICU. Blood tests and clinical evaluations of neurological status, consisting of questions about subjects' functional abilities and medical history, will occur in the Georgetown ICU once every 24 hours through post-enrollment Day 5. Additionally, subjects will receive daily chest x-rays, and daily EKGs (exams that monitor how your heart is doing by placing electrodes, or small monitors, on your skin in specific locations). Similar clinical evaluations will occur at Day 30 and Day 90. Should subjects be discharged at these time points, day 30 assessments will occur over the phone, and day 90 assessments will occur in-person at Georgetown University Medical Center.
Interventions
- DRUG Placebo
- DRUG Albumin
- PROCEDURE Brain MRI with and without contrast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2009-09 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00990509
The ClinicalTrials.gov registry entry for NCT00990509 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00990509 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00990509 about?
NCT00990509 is a clinical study titled "Albumin for Intracerebral Hemorrhage Intervention". The purpose of this study is to find out what effects, good and bad, the medication Albumin has on subjects who have experienced a type of stroke known as an intracerebral hemorrhage (ICH). An ICH is when spontaneous bleeding into the brain occurs due to fragile blood vessels. This research is bein...
What is the current status of trial NCT00990509?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2009-09. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00990509?
The interventions under investigation include: Placebo (DRUG), Albumin (DRUG), Brain MRI with and without contrast (PROCEDURE).
Who is sponsoring clinical trial NCT00990509?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
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