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Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke (ZODIAC Trial)
Phase 3
Waitlist Available
Led By Anne W Alexandrov, PhD
Research Sponsored by University of Tennessee Health Science Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured every 10 minutes from initiation of positioning up until thrombectomy commences or 2 hours - whichever comes first
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing if laying stroke patients flat on their back can improve blood flow to the brain and prevent symptoms from getting worse. It targets patients with severe strokes and aims to see if this simple method can help reduce long-term disability.
Eligible Conditions
- Stroke
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured every 10 minutes from initiation of positioning up until thrombectomy commences or 2 hours - whichever comes first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured every 10 minutes from initiation of positioning up until thrombectomy commences or 2 hours - whichever comes first
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Early Neurologic Deterioration (END) on the National Institute of Health Stroke Scale Occurring During the Positioning Intervention
Secondary study objectives
Diagnosis of Pneumonia Made During Hospitalization in a Patient Free From Pneumonia at Time of Hospital Admission
Modified Rankin Scale Score at 90-days from Stroke Onset
Modified Rankin Scale Score at Hospital Discharge or Day 7
+3 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Zero Degree HOBExperimental Treatment1 Intervention
Randomization to zero degree head of bed positioning until the time of initiation of thrombectomy
Group II: Thirty Degree HOBActive Control1 Intervention
Randomization to thirty degree head of bed positioning until the time of initiation of thrombectomy
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Who is running the clinical trial?
University of Tennessee Health Science CenterLead Sponsor
48 Previous Clinical Trials
24,407 Total Patients Enrolled
University of TennesseeLead Sponsor
198 Previous Clinical Trials
144,528 Total Patients Enrolled
2 Trials studying Stroke
2,388 Patients Enrolled for Stroke
National Institute of Nursing Research (NINR)NIH
606 Previous Clinical Trials
10,378,534 Total Patients Enrolled
15 Trials studying Stroke
7,141 Patients Enrolled for Stroke
Anne W Alexandrov, PhDPrincipal InvestigatorUniversity of Tennessee Health Science Center at Memphis