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NCT03263117 · ClinicalTrials.gov registry record · Phase 4
SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke
A Phase 4 study of Stroke, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 4
- Development phase
- 260
- Enrollment target
- 11
- Study locations
NCT03263117: Completed Phase 4 study of Stroke, sponsored by The University of Texas Health Science Center, Houston.
NCT03263117 is a Phase 4 study of Stroke that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 260 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (98% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03263117, a Phase 4 study of Stroke, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 260 participants
- Enrollment target
- 11
- Study locations
Study Summary
Objectives: This study aims to estimate overall treatment benefit (improvement in disability) among acute ischemic stroke patients that are randomized to General Anesthesia (GA) compared with Sedation (CS) during endovascular therapy. Assess safety (as measured by incidence of symptomatic intracranial hemorrhage); rates of Endovascular therapy (EVT) procedural complications, reperfusion; and quality of life. Hypothesis: GA during EVT for acute ischemic stroke improves functional outcomes at 90 days compared to sedation.
Primary Outcome
mRS ranges from 0 to 6, with higher scores indicating greater disability. 6 categories are reported: number of participants who had a score of 0, 1, 2, 3, or 4 will be reported separately as 5 categories, and those who had a score of 5 or 6 will be combined and reported as a single category. 0: no symptoms/normal (physical, cognitive etc.) 1. no significant disability despite symptoms; able to carry out all usual duties and activities 2. slight disability; unable to carry out all previous acti
Conditions Studied
Interventions
- DRUG Sedation
- DRUG General Anesthesia (GA)
- PROCEDURE Intra-arterial Thrombectomy
Study Locations (11)
Texas
- Memorial Hermann Hospital System - Memorial City Medical Center - Houston
- Baylor College of Medicine - Houston
- University of Texas Health Science Center Houston with Memorial Hermann Hospital System - The Medical Center - Houston
- Memorial Hermann Hospital System - The Woodlands Medical Center - The Woodlands
Pennsylvania
- Geisinger Health - Danville
- Temple University - Philadelphia
Indiana
- Indiana University College of Medicine - Indianapolis
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Kentucky
- Henry Ford Health System - Louisville
New York
- Rochester Regional Health - Rochester
North Carolina
- Wake Forest Baptist Health - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2018-07-01 |
| Est. Completion | 2023-04-22 |
| Phase | Phase 4 |
What the finished NCT03263117 record still lists
NCT03263117 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Stroke appearing as the primary indexed condition, and to 3 interventions - of which Sedation is the first listed.
NCT03263117 lists 11 locations in 7 states (Texas, Pennsylvania, Indiana).
Frequently Asked Questions
What is clinical trial NCT03263117 about?
NCT03263117 is a clinical study titled "SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke". Objectives: This study aims to estimate overall treatment benefit (improvement in disability) among acute ischemic stroke patients that are randomized to General Anesthesia (GA) compared with Sedation (CS) during endovascular therapy. Assess safety (as measured by incidence of symptomatic intracran...
What is the current status of trial NCT03263117?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 260 participants. The study started on 2018-07-01. Estimated completion is 2023-04-22.
What conditions does trial NCT03263117 study?
This clinical trial studies the following conditions: Stroke.
What interventions are being tested in trial NCT03263117?
The interventions under investigation include: Sedation (DRUG), General Anesthesia (GA) (DRUG), Intra-arterial Thrombectomy (PROCEDURE).
Who is sponsoring clinical trial NCT03263117?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03263117 being conducted?
This trial has 11 study locations across Indiana, Iowa, Kentucky, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stroke
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03263117's enrollment target sits among peer trials
260 82nd of 454 higher than 373 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke 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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