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NCT02039375 · ClinicalTrials.gov registry record · NA
Safety Study of Post Intravenous tPA Monitoring in Ischemic Stroke
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
NCT02039375: Completed NA study, sponsored by Johns Hopkins University.
NCT02039375 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 35 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02039375, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
Study 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.
Interventions
- OTHER "Hopkins" post tPA for ischemic stroke monitoring protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2014-03-01 |
| Est. Completion | 2018-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02039375
The ClinicalTrials.gov registry entry for NCT02039375 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which "Hopkins" post tPA for ischemic stroke monitoring protocol is the first listed.
NCT02039375 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02039375 about?
NCT02039375 is a clinical study titled "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. I...
What is the current status of trial NCT02039375?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2014-03-01. Estimated completion is 2018-06-30.
What interventions are being tested in trial NCT02039375?
The interventions under investigation include: "Hopkins" post tPA for ischemic stroke monitoring protocol (OTHER).
Who is sponsoring clinical trial NCT02039375?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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