Intravenous (IV) tissue plasminogen activator (tPA) is the only FDA-approved therapy for treatment of acute ischemic stroke. In the United States, IV tPA is typically administered in the Emergency Department (ED) for patients presenting with acute ischemic stroke within 4.5 hours of symptom onset. It is current practice that post-tPA patients are monitored in an intensive care unit or intensive care unit (ICU)-like setting for at least 24 hours, in part due to frequent vital sign and neurological monitoring that is currently the standard of care. However, rigorous evidence to support this practice is largely lacking. In a retrospective analysis of 153 patients receiving IV tPA at Johns Hopkins Hospital (JHH) and Johns Hopkins Bayview Medical Center (JHBMC), investigators have shown that most patients who have ICU needs in the first 24 hours after tPA administration develop such needs by the end of the tPA infusion. Patients without ICU needs by the end of the tPA infusion, do not require further ICU resources if patients' presenting NIH Stroke Scale (NIHSS) is below 10. This study is a prospective clinical trial that aims at establishing the first proof-of-concept and feasibility of whether patients with a low NIHSS (NIHSS 9 or less) and that do not need ICU care by the end of the tPA infusion, can be monitored safely in a non-ICU setting with a novel monitoring protocol. Identifying post-tPA patients who can be safely monitored in a non-ICU environment may improve cost-effective utilization of ICU resources and reduce the length of hospitalization for stroke patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
35
The "Hopkins" post tPA monitoring protocol includes: vital signs and neurochecks, per standard of care for the first two hours (every 15 minutes), then on arrival to unit, in one hour, every 2 hours for 8 hours, and every 4 hours to complete 24 hours.
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration
Time frame: 24 hours
Severity of Stroke at 24 Hours as Assessed by the National Institutes of Health Stroke Scale (NIHSS)
The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke.
Time frame: 24 hours
Degree of Disability as Assessed by the Modified Rankin Score (mRS)
The mRS is a scale of disability with a score range from 0-6. 0 - no symptoms, back to normal. 1. \- some symptoms, able to do all prior activities, does not need help from others. 2. \- some symptoms, unable to do all prior activities, does not need help from others. 3. \- needs help from others, able to walk. 4. \- needs help from other, unable to walk without help. 5. \- needs total care. 6. \- the patient has expired.
Time frame: At the time of discharge from the hospital, up to 90 days
Severity of Symptoms of Stroke at 90 Days as Assessed by the NIHSS
The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke.
Time frame: At 90 days
Degree of Disability at 90 Days as Assessed by the mRS
The mRS is a scale of disability with a score range from 0-6. 0-no symptoms, back to normal. 1. some symptoms, able to do all prior activities, does not need help from others. 2. some symptoms, unable to do all prior activities, does not need help from others. 3. needs help from others, able to walk. 4. needs help from other, unable to walk without help. 5. needs total care. 6. the patient has expired.
Time frame: At 90 days
Mortality at 90 Days
Time frame: 90 days
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