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NCT00784134 · ClinicalTrials.gov registry record · Phase 3
Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
A Phase 3 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
NCT00784134: Completed Phase 3 study, sponsored by Johns Hopkins University.
NCT00784134 is a Phase 3 study that has completed, run by Johns Hopkins University. The registered enrollment target is 500 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00784134, a Phase 3 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
Study Summary
The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH \< 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).
Primary Outcome
Analysis modified on September 29, 2015 to account for adaptive randomization. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).
Interventions
- OTHER Normal saline
- DRUG Alteplase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2009-07 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
What the finished NCT00784134 record still lists
NCT00784134 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal saline is the first listed.
NCT00784134 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00784134 about?
NCT00784134 is a clinical study titled "Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III". The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on su...
What is the current status of trial NCT00784134?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2009-07. Estimated completion is 2016-01.
What interventions are being tested in trial NCT00784134?
The interventions under investigation include: Normal saline (OTHER), Alteplase (DRUG).
Who is sponsoring clinical trial NCT00784134?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00784134's enrollment target sits among peer trials
500 744th of 2000 higher than 1,226 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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