StrokeOPTIMISTNCT02039375
Safety Study of Post Intravenous tPA Monitoring in Ischemic Stroke
A study testing "Hopkins" post tPA for ischemic stroke monitoring protocol in people with Stroke and Ischemic Stroke, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Ischemic Stroke
- What is being tested?
- "Hopkins" post tPA for ischemic stroke monitoring protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2014to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
Official title: 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.
- Conditions
- Stroke, Ischemic Stroke
- Being tested
- "Hopkins" post tPA for ischemic stroke monitoring protocol
- Keywords
- IV tPA, Thrombolysis, Stroke, Ischemic, Monitoring
- Medical subject headings
- Stroke, Ischemic Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Hopkins" post tPA for ischemic stroke monitoring protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| "Hopkins" post tPA monitoring protocol | Experimental | 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. Receives: Other: "Hopkins" post tPA for ischemic stroke monitoring protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration
Measured: 24 hours
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 90 days
Mortality at 90 Days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study start1 Mar 2014
- Primary completion21 Mar 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm study
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victor C Urrutia, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039375
- Sponsor's protocol ID
- NA_00087038
- Acronym
- OPTIMIST
- Status last verified
- Mar 2020
- First submitted
- 16 Jan 2014
- Last updated
- 23 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 24533130Faigle 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.
PubMed 31839859
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Post Tpa-Iv Monitoring in Ischemic STroke
- ClinicalTrials.gov ID
- NCT02039375
- Acronym / sponsor ID
- OPTIMIST / NA_00087038
- Conditions
- Stroke, Ischemic Stroke
- Keywords
- IV tPA, Thrombolysis, Stroke, Ischemic, Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 21 Mar 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Posted 23 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm study
| Arm | Type | Receives |
|---|---|---|
| "Hopkins" post tPA monitoring protocol | Experimental | Other: "Hopkins" post tPA for ischemic stroke monitoring protocolPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- For patients receiving IV tPA according to the current standard of care, the following exclusion criteria apply:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Hopkins" post tPA for ischemic stroke monitoring protocolThe "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. | Other | "Hopkins" post tPA monitoring protocol |
Primary outcome
Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration
Time frame: 24 hours
5 secondary outcomes
Severity of Stroke at 24 Hours as Assessed by the National Institutes of Health Stroke Scale (NIHSS)
Time frame: 24 hours
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
Severity of Symptoms of Stroke at 90 Days as Assessed by the NIHSS
Time frame: At 90 days
Degree of Disability at 90 Days as Assessed by the mRS
Time frame: At 90 days
Mortality at 90 Days
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24533130Faigle 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.
- Results publication: PubMed 31839859Faigle 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.
- Preliminary workLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor C Urrutia, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Hopkins" post tPA for ischemic stroke monitoring protocol in people with Stroke and Ischemic Stroke, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02039375, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.