Trial Outcomes & Findings for Safety Study of Post Intravenous tPA Monitoring in Ischemic Stroke (NCT NCT02039375)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

24 hours

Results posted on

2020-03-23

Participant Flow

Participant milestones

Participant milestones
Measure	"Hopkins" Post tPA Monitoring Protocol Patients treated with IV tissue plasminogen activator (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.
Overall Study STARTED	35
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	"Hopkins" Post tPA Monitoring Protocol Patients treated with IV tissue plasminogen activator (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.
Overall Study Lost to Follow-up	2

Baseline Characteristics

Safety Study of Post Intravenous tPA Monitoring in Ischemic Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	"Hopkins" Post tPA Monitoring Protocol n=35 Participants 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.
Age, Continuous	54 years n=99 Participants
Sex: Female, Male Female	14 Participants n=99 Participants
Sex: Female, Male Male	21 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	22 Participants n=99 Participants
Race (NIH/OMB) White	13 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	35 Participants n=99 Participants

PRIMARY outcome

Timeframe: 24 hours

Outcome measures

Outcome measures
Measure	"Hopkins" Post tPA Monitoring Protocol n=35 Participants 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.
Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	"Hopkins" Post tPA Monitoring Protocol n=35 Participants 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.
Severity of Stroke at 24 Hours as Assessed by the National Institutes of Health Stroke Scale (NIHSS)	1 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	"Hopkins" Post tPA Monitoring Protocol n=35 Participants 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.
Degree of Disability as Assessed by the Modified Rankin Score (mRS)	1 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: At 90 days

Population: The NIHSS assessment at 90 days was not done for 7 participants.

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.

Outcome measures

Outcome measures
Measure	"Hopkins" Post tPA Monitoring Protocol n=28 Participants 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.
Severity of Symptoms of Stroke at 90 Days as Assessed by the NIHSS	0 score on a scale Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	"Hopkins" Post tPA Monitoring Protocol n=33 Participants 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.
Degree of Disability at 90 Days as Assessed by the mRS	0 score on a scale Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: 90 days

Outcome measures

Outcome measures
Measure	"Hopkins" Post tPA Monitoring Protocol n=35 Participants 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.
Mortality at 90 Days	1 Participants

Adverse Events

"Hopkins" Post tPA Monitoring Protocol

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	"Hopkins" Post tPA Monitoring Protocol n=35 participants at risk 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.
Cardiac disorders Mortality	2.9% 1/35 • Number of events 1 • 90 days

Other adverse events

Adverse event data not reported

Additional Information

Victor C. Urrutia, MD

Johns Hopkins University School of Medicine

Phone: 4109552228

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place