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NCT01827046 · ClinicalTrials.gov registry record · Phase 3
Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III
A Phase 3 study of Intracerebral Hemorrhage, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 3
- Development phase
- 499
- Enrollment target
- 20
- Study locations
NCT01827046: Completed Phase 3 study of Intracerebral Hemorrhage, sponsored by Johns Hopkins University.
NCT01827046 is a Phase 3 study of Intracerebral Hemorrhage that has completed, run by Johns Hopkins University. The registered enrollment target is 499 participants, below the 1,090-participant average among 31 other Intracerebral Hemorrhage trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01827046, a Phase 3 study of Intracerebral Hemorrhage, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 499 participants
- Enrollment target
- 20
- Study locations
Study Summary
A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).
Primary Outcome
Dichotomized, adjudicated, cross-sectional modified Rankin Scale (mRS) score 0-3 vs. 4-6 at 365 days post-ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep). Ictus refers to symptom onset. The 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 cause
Conditions Studied
Interventions
- DRUG rt-PA
Study Locations (20)
Illinois
- Northwestern University - Chicago
- Rush University - Chicago
- University of Illinois at Chicago - Chicago
- University of Chicago Medical Center - Chicago
- Northshore University Health System, Evanston - Evanston
- Loyola University Chicago - Maywood
California
- Mercy San Juan Medical Center - Carmichael
- Scripps Health - La Jolla
- University of California, Los Angeles - Los Angeles
- University of California, San Diego - San Diego
- Stanford University - Stanford
Arizona
- Banner Good Samaritan Hospital - Phoenix
- Barrow Neurological Institute - Phoenix
Connecticut
- Hartford Hospital - Hartford
- Yale University - New Haven
Alabama
- University of Alabama at Birmingham - Birmingham
Florida
- Mayo Clinic, Jacksonville - Jacksonville
Georgia
- Gwinnett Medical Center - Lawrenceville
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 499 participants |
| Start Date | 2013-12-30 |
| Est. Completion | 2018-09 |
| Phase | Phase 3 |
What the finished NCT01827046 record still lists
NCT01827046 is an interventional study that assigns participants to a tested intervention. The registered 499 participants enrollment target is mid-sized for trials with a published cap, below the 1,090-participant average among 31 other Intracerebral Hemorrhage trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Intracerebral Hemorrhage appearing as the primary indexed condition, and to 1 intervention - of which rt-PA is the first listed.
NCT01827046 names 20 study sites across 9 states, led by Illinois, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT01827046 about?
NCT01827046 is a clinical study titled "Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III". A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).
What is the current status of trial NCT01827046?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 499 participants. The study started on 2013-12-30. Estimated completion is 2018-09.
What conditions does trial NCT01827046 study?
This clinical trial studies the following conditions: Intracerebral Hemorrhage.
What interventions are being tested in trial NCT01827046?
The interventions under investigation include: rt-PA (DRUG).
Who is sponsoring clinical trial NCT01827046?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01827046 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01827046's enrollment target sits among peer trials
499 14th of 31 higher than 18 of 31 other Intracerebral Hemorrhage trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Intracerebral Hemorrhage 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.
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