Safety Study of Post Intravenous tPA Monitoring in Ischemic Stroke

NCT02039375 | Completed Results DMC

• 1 other identifier: NA_00087038
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Ischemic Stroke

Keywords

IV tPA; Thrombolysis; Stroke; Ischemic; Monitoring

Outcome Measures

Primary Outcomes (1)

• Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration

  24 hours

Secondary Outcomes (5)

• Severity of Stroke at 24 Hours as Assessed by the National Institutes of Health Stroke Scale (NIHSS)

  24 hours

• Degree of Disability as Assessed by the Modified Rankin Score (mRS)

  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

  At 90 days

• Degree of Disability at 90 Days as Assessed by the mRS

  At 90 days

• Mortality at 90 Days

  90 days

Study Arms (1)

"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.

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

Interventions

"Hopkins" post tPA for ischemic stroke monitoring protocol OTHER

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.

"Hopkins" post tPA monitoring protocol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• 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.

  PMID: 24533130 BACKGROUND

• 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):11-15. doi: 10.1177/1941874419845229. Epub 2019 May 5.

  PMID: 31839859 RESULT

Related Links

• Preliminary work

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Victor C. Urrutia, MD
• Organization: Johns Hopkins University School of Medicine

vurruti1@jhmi.edu

4109552228

Study Officials

• Victor C Urrutia, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm study

Study Record Dates

• First Submitted: January 16, 2014
• First Posted: January 17, 2014
• Study Start: March 1, 2014
• Primary Completion: March 21, 2018
• Study Completion: June 30, 2018
• Last Updated: March 23, 2020
• Results First Posted: March 23, 2020

Record last verified: 2020-03

Locations

US (1)