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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Hopkins" post tPA monitoring protocol | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Hopkins" post tPA for ischemic stroke monitoring protocol | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration | 24 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
For patients receiving IV tPA according to the current standard of care, the following exclusion criteria apply:
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| Name | Affiliation | Role |
|---|---|---|
| Victor C Urrutia, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24533130 | Background | Faigle R, Sharrief A, Marsh EB, Llinas RH, Urrutia VC. Predictors of critical care needs after IV thrombolysis for acute ischemic stroke. PLoS One. 2014 Feb 12;9(2):e88652. doi: 10.1371/journal.pone.0088652. eCollection 2014. | |
| 31839859 | Result | Faigle R, Butler J, Carhuapoma JR, Johnson B, Zink EK, Shakes T, Rosenblum M, Saheed M, Urrutia VC. Safety Trial of Low-Intensity Monitoring After Thrombolysis: Optimal Post Tpa-Iv Monitoring in Ischemic STroke (OPTIMIST). Neurohospitalist. 2020 Jan;10(1):11-15. doi: 10.1177/1941874419845229. Epub 2019 May 5. |
| Label | URL |
|---|---|
| Preliminary work | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | "Hopkins" Post tPA Monitoring Protocol | Patients treated with IV tissue plasminogen activator (tPA) 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. "Hopkins" post tPA for ischemic stroke monitoring protocol: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | "Hopkins" Post tPA Monitoring Protocol | Patients treated with IV tPA 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. "Hopkins" post tPA for ischemic stroke monitoring protocol: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration | Posted | Count of Participants | Participants | 24 hours |
|
90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | "Hopkins" Post tPA Monitoring Protocol | Patients treated with IV tPA 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. "Hopkins" post tPA for ischemic stroke monitoring protocol: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mortality | Cardiac disorders | Systematic Assessment | One patient died several weeks after discharge from a cardiovascular event unrelated to his stroke or the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victor C. Urrutia, MD | Johns Hopkins University School of Medicine | 4109552228 | vurruti1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2013 | Feb 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Single arm study
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|
| 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.
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| 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.
| At 90 days |
| Mortality at 90 Days | 90 days |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 24 hours |
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| Secondary | 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.
| Posted | Median | Full Range | score on a scale | At the time of discharge from the hospital, up to 90 days |
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|
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| Secondary | 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. | The NIHSS assessment at 90 days was not done for 7 participants. | Posted | Median | Inter-Quartile Range | score on a scale | At 90 days |
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| Secondary | 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.
| Posted | Median | Full Range | score on a scale | At 90 days |
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| Secondary | Mortality at 90 Days | Posted | Count of Participants | Participants | 90 days |
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| 1 |
| 35 |
| 1 |
| 35 |
| 0 |
| 35 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |