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Completed

NCT Number: NCT02039375

Safety Study of Post Intravenous tPA 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemia Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"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.

Primary outcomes

  1. Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration

    Time frame: 24 hours

Secondary outcomes

  1. Severity of Stroke at 24 Hours as Assessed by the National Institutes of Health Stroke Scale (NIHSS)

    Time frame: 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.

  2. Degree of Disability as Assessed by the Modified Rankin Score (mRS)

    Time frame: 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.

    • - 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.

  3. Severity of Symptoms of Stroke at 90 Days as Assessed by the NIHSS

    Time frame: 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.

  4. Degree of Disability at 90 Days as Assessed by the mRS

    Time frame: At 90 days

    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.

  5. Mortality at 90 Days

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Optimal Post Tpa-Iv Monitoring in Ischemic STroke

Acronym: OPTIMIST

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 17, 2014
Registry last updated
Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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