Safety Study of Post Intravenous tPA Monitoring in Ischemic Stroke (OPTIMIST)

Optimal Post Tpa-Iv Monitoring in Ischemic STroke

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 Overview

• Status: Completed
• Conditions: Stroke; Ischemic Stroke
• Intervention / Treatment: Other: "Hopkins" post tPA for ischemic stroke monitoring protocol

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: "Hopkins" post tPA 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.

Other: "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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Johns Hopkins University

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Preliminary work
• Results paper

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): March 21, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: January 16, 2014
• First Submitted That Met QC Criteria: January 16, 2014
• First Posted (Estimate): January 17, 2014

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Stroke; Monitoring; Ischemic; Thrombolysis; IV tPA
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: NA_00087038