Safety Study of Post Intravenous tPA Monitoring in Ischemic Stroke
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 6/22/2018 |
| Start Date: | March 2014 |
| End Date: | December 2019 |
| Contact: | Victor C Urrutia, MD |
| Email: | vurruti1@jhmi.edu |
| Phone: | 410-955-2228 |
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 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.
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 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.
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
We found this trial at
1
site
1800 Orleans St.
Baltimore, Maryland 21287
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Victor C Urrutia, MD
Phone: 410-955-2228
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