Safety Study of Post Intravenous tPA Monitoring in Ischemic Stroke

Stroke Clinical Trial

— OPTIMIST  

Official title:

Optimal Post Tpa-Iv Monitoring in Ischemic STroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039375
• Other study ID #: NA_00087038
• Status: Completed
• Phase: N/A
• Start date: March 1, 2014
• Est. completion date: June 30, 2018

Study information

• Verified date: March 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 30, 2018
• Est. primary completion date: March 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• "Hopkins" post tPA for ischemic stroke monitoring protocol
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.

Locations

Country	Name	City	State
United States	The Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Faigle 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) — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration		24 hours
Secondary	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.	24 hours
Secondary	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.	At the time of discharge from the hospital, up to 90 days
Secondary	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.	At 90 days
Secondary	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.	At 90 days
Secondary	Mortality at 90 Days		90 days

External Links

•   Preliminary work
•   Results paper