An observational study in Acute Stroke, Intracranial Hemorrhages and Subarachnoid Hemorrhage, sponsored by Duke University. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-28.
Sponsored by Duke University · Observational
The purpose of this program is to develop a regional integrated stroke system that identifies, classifies, and treats patients with acute ischemic stroke more rapidly and effectively with reperfusion therapy.
The design is based upon the implementation of best practice, that is, based on a comprehensive review of AHA guidelines regarding treatment of acute stroke, ICH (intracranial hemorrhage) and SAH(sub arachnoid hemorrhage). In the second phase, the project will be doing national and international surveys of best practices among comprehensive stroke centers and then combine evidence based guidelines and recommendation as well as expert consensus and guidelines when high level evidence is not available from the published literature. The aim to improve public stroke awareness, stroke symptom recognition within the time benefit window for treatment and calling 9-1-1, EMS transportation, and the proportion and speed of reperfusion therapy (fibrinolytic and in appropriate patients- endovascular treatment) in eligible patients. These improvements in acute stroke care delivery are expected to result in lower mortality, fewer recurrent strokes, and improved long term functional outcomes that we will measure.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 21,646 is above the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients who undergo the Acute Code Stroke Process, who demonstrate symptoms of a possible acute stroke, and are presenting to a Spoke or Hub within the Southeastern US at the 9 Hub Hospitals and Spokes associated with those Hubs participating in the project.
Exclusion Criteria:
Patients that undergo the Code Stroke process at Spoke Hospitals
Patients that undergo the Code Stroke process at Hub Hospitals
Patients that undergo the Code Stroke process at a Spoke Hospital and transfer to the Hub Hospital
Change in Time from door to drug as measured by medical record
The time frame starting from the earliest time that the patient is documented as arriving to the hospital to the beginning time of the administration of the drug (TPA)
Time frame: From baseline (Q1, 2017), to Quarter 4 (2020)
Change in Time from Door to Tici 2c/3 flow measured by medical record
The time frame starting from the earliest time that the patient is documented as arriving to the hospital to the beginning time of Tici 2c/c flow noted in the vessel
Time frame: From baseline (Q1, 2017), to Quarter 4 (2020)
Change in Time from Door to Administration of Reversal Agent as measured by medical record
The time frame starting from the earliest time that the patient is documented as arriving to the hospital to the beginning time of the administration of the drug (reversal agent)
Time frame: From baseline (Q1, 2017), to Quarter 4 (2020)
Change in Number of Deaths from Stroke as measure by medical record
Count of number of deaths from stroke
Time frame: From baseline (Q1, 2017) to Quarter 4 (2020)
Change in Functional Long Term Outcomes as measured by Modified Rankin Scale
Modified Ranking Scale ranges from 0-6, 0 No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
Time frame: From baseline , 3 months
Plan to share: No
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Duke University