Safety Study of Post Intravenous tPA Monitoring in Ischemic Stroke

Not Applicable

Completed

Conditions: Ischemic Stroke
Stroke

Interventions: Other: "Hopkins" post tPA for ischemic stroke monitoring protocol

Registration Number: NCT02039375

Lead Sponsor: Johns Hopkins University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
"Hopkins" post tPA monitoring protocol	"Hopkins" post tPA for ischemic stroke monitoring protocol	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration	24 hours

Secondary Outcome Measures

Name	Time	Method
Severity of Stroke at 24 Hours as Assessed by the National Institutes of Health Stroke Scale (NIHSS)	24 hours	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.
Degree of Disability as Assessed by the Modified Rankin Score (mRS)	At the time of discharge from the hospital, up to 90 days	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.
Severity of Symptoms of Stroke at 90 Days as Assessed by the NIHSS	At 90 days	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.
Degree of Disability at 90 Days as Assessed by the mRS	At 90 days	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.
Mortality at 90 Days	90 days