Safety Study of Post Intravenous tPA Monitoring in Ischemic Stroke "OPTIMIST"

Recruiting

Phase 1/2 Results N/A

Trial Description

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), we 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 their 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.

Conditions

Interventions

  • Hopkins post tPA for ischemic stroke monitoring protocol Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: "Hopkins" post tPA monitoring protocol
    Description: Patients treated with IV tPA for acute stroke will be monitored in a non-ICU setting following a new schedule for vital signs and neurochecks
  • "Hopkins" post tPA for ischemic stroke monitoring protocol Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: "Hopkins" post tPA monitoring protocol
    Description: 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.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Health Services Research
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Need for ICU care/interventions within the first 24 hours of IV tPA administration 24 hours Yes
Secondary NIHSS at 24 hours 24 hours No
Secondary Modified Rankin Score at discharge Discharge from the hospital No
Secondary NIHSS at 90 days 90 days No
Secondary Modified Rankin Score at 90 days 90 days No
Secondary Mortality at 90 days 90 days Yes
Secondary Severity of stroke at 24 hours, using the National Institutes of Health Stroke Scale (NIHSS) 24 hours No
Secondary Degree of disability will be measured using the Modified Rankin Score (mRS) Discharge from the hospital No
Secondary Severity of symptoms of stroke will be measured using the NIHSS at 90 days 90 days No
Secondary Degree of disability will be measured at 90 days, using the mRS 90 days No

Sponsors