Safety Study of Post Intravenous tPA Monitoring in Ischemic Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Optimal Post Tpa-Iv Monitoring in Ischemic STroke

Conditions
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Stroke, Ischemic Stroke

Intervention / Treatment
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* Other: Hopkins post tPA for ischemic stroke monitoring protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide written informed consent (or a Legally Authorized Representative (LAR) available to provide informed consent) and comply with study assessments for the full duration of the study. Age 18-80 years Patients to be included will be diagnosed as having an acute ischemic stroke by history and physical exam and receive IV tPA within 4.5 hours of symptom onset according to current guidelines for acute stroke care. NIHSS at presentation <10 Patients do not have ICU needs in the judgment of the treating ED physician or neurologist by the end of the tPA infusion NIHSS at the end of tPA infusion <10 Exclusion Criteria: For patients receiving IV tPA according to the current standard of care, the following exclusion criteria apply: Age <17 or >80 ICU need or indication by the end of the tPA infusion NIHSS >9 at presentation or at the end of the tPA infusion Indication/need for endovascular recanalization therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hopkins post tPA monitoring protocol<br>Patients treated with IV tPA (intravenous tissue Plasminogen Activator) for acute stroke will be monitored in a non-ICU setting following the Hopkins post tPA monitoring protocol, a new schedule for vital signs and neurochecks. These patients will have vital signs and neurochecks every 15 minutes for two hours, then once upon admission to the stroke unit and after one hour, then every two hours for 8 hours and then every four hours until 24 hours post tPA. | Other: Hopkins post tPA for ischemic stroke monitoring protocol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. - some symptoms, able to do all prior activities, does not need help from others. - some symptoms, unable to do all prior activities, does not need help from others. - needs help from others, able to walk. - needs help from other, unable to walk without help. - needs total care. - the patient has expired. | 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. | 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. some symptoms, able to do all prior activities, does not need help from others. some symptoms, unable to do all prior activities, does not need help from others. needs help from others, able to walk. needs help from other, unable to walk without help. needs total care. the patient has expired. | At 90 days | 
| Mortality at 90 Days |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IV tPA, Thrombolysis, Stroke, Ischemic, Monitoring