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Optimal Post Tpa-Iv Monitoring in Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT03734640
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : June 24, 2021
Sponsor:
Collaborators:
Genentech, Inc.
Johns Hopkins University
The George Institute for Global Health, Australia
Information provided by (Responsible Party):
Craig Anderson, The George Institute for Global Health, China

Brief Summary:
OPTIMISTmain is an investigator-initiated and conducted, international, multicentre, stepped wedge cluster randomized controlled trial comparing the effects of different intensities of nursing care monitoring for patients with acute ischemic stroke of mild severity and without critical care needs after IV-tPA.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Patients Receiving Reperfusion Therapy Other: Low-intensity monitoring strategy Other: Guideline recommended standard monitoring Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7200 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: stepped wedge cluster randomized
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Guardian consent for intervention as standard of care service provision. Outcome assessed by independent researcher blind to treatment allocation
Primary Purpose: Supportive Care
Official Title: Optimal Post Tpa-Iv Monitoring in Ischemic Stroke
Actual Study Start Date : April 28, 2021
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : December 1, 2023

Arm Intervention/treatment
Placebo Comparator: Guideline recommended standard monitoring
vital signs (HR, BP) and neurological assessment (GCS and NIHSS) 15-30mins x 2 hours, 30mins x 6 hours, 1hourly x 16 hours in usual care monitoring environment
Other: Guideline recommended standard monitoring
Post-tpa patients will be monitored in the usual care monitoring environment

Active Comparator: Low-intensity monitoring strategy
vital signs (HR, BP) and neurological assessment (GCS and/or NIHSS) 15-30mins x 2 hours, 2hourly x 8 hours, 4hourly x 14 hours in a non-ICU ward
Other: Low-intensity monitoring strategy
Post-tpa patients will be monitored in a lower intensity with less vital status and neurological assessment




Primary Outcome Measures :
  1. modified Rankin scale (mRS); shift analysis across full range of scores [ Time Frame: day 90 ]
    Physical function measured according to a 7 level categorical scale, where 0-1 indicates no or minimal symptoms, 2-5 indicates increasing levels of disability/dependencey, and 6=death


Secondary Outcome Measures :
  1. frequency of major Symptomatic intracerebral hemorrhage [ Time Frame: day 90 ]
    intracerebral hemorrhage on brain imaging associated with significant neurological deterioration or death over 24 hours

  2. Measures of hospital costs [ Time Frame: day 90 ]
    to allow economic analysis of treatment interventions at a country level

  3. any serious adverse event during follow-up [ Time Frame: Within 90 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults (age ≥18 years);
  • have received IV alteplase for AIS according to standard criteria;
  • have a mild-moderate level of neurological impairment (e.g. score <10 on the NIHSS);
  • stable and without any critical care needs at the end of the infusion of alteplase.

Exclusion Criteria:

  • major neurological impairment;
  • definite clinical contraindication or indication to either low-intensity or standard neurological monitoring.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734640


Contacts
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Contact: Craig Anderson, PhD +61 410476311 canderson@georgeinstitute.org.au
Contact: Victor C Urrutia, MD +1 410-955-2228 vurruti1@jhmi.edu

Locations
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Sponsors and Collaborators
Craig Anderson
Genentech, Inc.
Johns Hopkins University
The George Institute for Global Health, Australia
Investigators
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Principal Investigator: Craig S Anderson, MD PhD The George Institute
Principal Investigator: Victor C Urrutia, MD Johns Hopkins University
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Responsible Party: Craig Anderson, Executive Director, The George Institute for Global Health, China
ClinicalTrials.gov Identifier: NCT03734640    
Other Study ID Numbers: OPTIMISTmain
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: June 24, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 12 months after completion of the study, experienced researchers can seek a copy of the database through requests to the Research Office of The George Institute
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 12 months after primary results publication
Access Criteria: Request with protocol to the Research Office of The George Institute

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis