Ischemic Stroke, Stroke
Conditions
Keywords
IV tPA, Thrombolysis, Stroke, Ischemic, Monitoring
Brief 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
OTHERHopkins 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.
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Single arm study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration | 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Stroke at 24 Hours as Assessed by the National Institutes of Health Stroke Scale (NIHSS) | 24 hours | 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. |
| Degree of Disability as Assessed by the Modified Rankin Score (mRS) | At the time of discharge from the hospital, up to 90 days | The mRS is a scale of disability with a score range from 0-6. 0 - no symptoms, back to normal. 1. \- some symptoms, able to do all prior activities, does not need help from others. 2. \- some symptoms, unable to do all prior activities, does not need help from others. 3. \- needs help from others, able to walk. 4. \- needs help from other, unable to walk without help. 5. \- needs total care. 6. \- the patient has expired. |
| Severity of Symptoms of Stroke at 90 Days as Assessed by the NIHSS | At 90 days | 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. |
| Degree of Disability at 90 Days as Assessed by the mRS | At 90 days | The mRS is a scale of disability with a score range from 0-6. 0-no symptoms, back to normal. 1. some symptoms, able to do all prior activities, does not need help from others. 2. some symptoms, unable to do all prior activities, does not need help from others. 3. needs help from others, able to walk. 4. needs help from other, unable to walk without help. 5. needs total care. 6. the patient has expired. |
| Mortality at 90 Days | 90 days | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hopkins Post tPA Monitoring Protocol 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.
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. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Hopkins Post tPA Monitoring Protocol |
|---|---|
| Age, Continuous | 54 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 35 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 1 / 35 |
Outcome results
Primary
Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hopkins Post tPA Monitoring Protocol | Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration | 0 Participants |
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. 1. \- some symptoms, able to do all prior activities, does not need help from others. 2. \- some symptoms, unable to do all prior activities, does not need help from others. 3. \- needs help from others, able to walk. 4. \- needs help from other, unable to walk without help. 5. \- needs total care. 6. \- the patient has expired.
Time frame: At the time of discharge from the hospital, up to 90 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hopkins Post tPA Monitoring Protocol | Degree of Disability as Assessed by the Modified Rankin Score (mRS) | 1 score on a scale |
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. 1. some symptoms, able to do all prior activities, does not need help from others. 2. some symptoms, unable to do all prior activities, does not need help from others. 3. needs help from others, able to walk. 4. needs help from other, unable to walk without help. 5. needs total care. 6. the patient has expired.
Time frame: At 90 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hopkins Post tPA Monitoring Protocol | Degree of Disability at 90 Days as Assessed by the mRS | 0 score on a scale |
Secondary
Mortality at 90 Days
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hopkins Post tPA Monitoring Protocol | Mortality at 90 Days | 1 Participants |
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.
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hopkins Post tPA Monitoring Protocol | Severity of Stroke at 24 Hours as Assessed by the National Institutes of Health Stroke Scale (NIHSS) | 1 score on a scale |
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.
Time frame: At 90 days
Population: The NIHSS assessment at 90 days was not done for 7 participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hopkins Post tPA Monitoring Protocol | Severity of Symptoms of Stroke at 90 Days as Assessed by the NIHSS | 0 score on a scale |