Clinical trial NCT02039375: Safety Study of Post Intravenous tPA Monitoring in Ischemic Stroke
Official title: Optimal Post Tpa-Iv Monitoring in Ischemic STroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Ischemic Stroke
Keywords: IV tPA
Thrombolysis
Stroke
Ischemic
Monitoring
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2014-01-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration
timeFrame: 24 hours
Secondary outcomes:
measure: Severity of Stroke at 24 Hours as Assessed by the National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 24 hours
measure: Degree of Disability as Assessed by the Modified Rankin Score (mRS)
timeFrame: At the time of discharge from the hospital, up to 90 days
measure: Severity of Symptoms of Stroke at 90 Days as Assessed by the NIHSS
timeFrame: At 90 days
measure: Degree of Disability at 90 Days as Assessed by the mRS
timeFrame: At 90 days
measure: Mortality at 90 Days
timeFrame: 90 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Victor C Urrutia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.