Optimal Post Tpa-Iv Monitoring in Ischemic Stroke

August 11, 2023 updated by: Craig Anderson
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Research question: Patients receiving thrombolytic therapy (tissue plasminogen activator [tPA]) for acute ischaemic stroke (AIS), have been monitored with a high intensity schedule of vital signs and neurologic assessments, which often requires 1:1 nursing and/or admission in an intensive care unit (ICU) or similar ward for at least 24 hours after receiving tPA. Studies indicate that patients with mild degrees of AIS after tPA do not require such intensive monitoring, yet most stroke services continue to follow a practice recommended in guidelines based on the initial cautious evaluation of tPA in AIS over 20 years ago.

Design: Stepped-wedge cluster randomised design. With 3 groups and 4 phases. All groups starting with standard care and in each subsequent phase, groups I through III will switch to the intervention (low-intensity monitoring).

Study centers: This is a global study. Approximately 157 hospitals ('sites') in Australasia, Europe, South American, and North American regions, who are willing to accept the randomized intervention change and adhere to the protocol, collect a required minimum data set on patients over 7 days in hospital (or discharge or death, if sooner), and record any serious adverse event (SAE) during and at clinical outcome assessed at 90 days of follow-up of patients.

Consent/randomization: Hospitals will be eligible if they are using the proposed low-intensity nursing monitoring strategy. A stepped-wedge cluster randomized design has been chosen to avoid contamination, facilitate hospital-wide implementation, and maximize adherence, as the intervention under investigation is to become usual standard of care. The process of one direction (from control to intervention) is to facilitate the low intensity monitoring protocol being applied in clinical practice. The stepped-wedge design means that all hospitals will be randomly allocated to 3 groups: in phase 1, all hospitals will be observed under standard care 'control' conditions according to guideline recommended monitoring; in phase 2, the first cluster of hospitals (Group I) will start receiving the intervention (low-intensity), and then sequentially, Groups II and III will start receiving the interventional package in phase 3 and 4, respectively, so that by phase 4, all hospitals will have the intervention. Those hospitals in Group I are exposed to the intervention for longest time, and those in Group III, the shortest time.

In each phase, hospitals are to maintain a register of all thrombolyzed AIS patients, and to identify all those eligible for, or excluded from participating in the study. Hospitals are required to manage at minimum target of at least 10 consecutive thrombolyzed AIS patients who fulfill the eligibility criteria (presumed 50% of all thrombolyzed AIS patients) over each 4 month period. The recruitment number will vary from 10 to 30 patients, according to seasonal fluctuation and overall numbers of thrombolyzed AIS patients across hospitals. The target number and time limits for each phase will be pre-determined and agreed to with each hospital, to ensure an orderly completion of the study.

On average, for Group I, the time for initiation of the low-intensive intervention is 4 months after activation into phase 1 of the study; for Groups II and III, the time periods for initiation of the low-intensive intervention are 6 and 9 months, after activation, respectively. Data collection will occur at baseline, the first 24 hours, Day 7 (or death or time of hospital discharge, if earlier), and at 90 days (end of follow-up). Patients will be asked to consent to being contacted at some future date to examine long-term outcomes, according to available resources.

A senior executive officer at each center will act as a 'guardian', to provide consent at an institutional level for the intervention to be applied as a 'low risk' intervention to clusters of patients as part of routine care; and written informed consent is to be subsequently obtained from participants, or their approved surrogates, for collection of medical data and participation in the follow-up assessments Randomized allocation of intervention will be assigned by a statistician not otherwise involved in the study according to a statistical program stratified by the country of the site.

Sample size: The sample size required to detect a plausible treatment effect on a clinical outcome in a stepped-wedge trial (3 groups, 4 phases) is 157 hospitals, each recruiting an average of 80 patients (20 per phase), for a total of 12,394 AIS patients. The basis of this calculation is that the study is designed with 90% power (one-sided α = 0.025) to detect non-inferiority (non-inferiority OR margin is 1.25, presumed actual OR is 1.0; the proportion of a bad outcome [mRS 2-6] is 50%) of low-intensity monitoring on the primary outcome. Assuming a stepped-wedge trial of 3 groups and 4 phases, 157 hospitals are required to be randomized into 3 groups of 53 hospitals, each recruiting an average of 16 patients per phase, for a total of 9340 subjects. Assuming 10% with missing primary endpoint data and 5% with nonadherence to randomized treatment, the overall sample size increases to an average of 20 subjects per hospital per phase (i.e. total sample size of 12,394 AIS patients). Allowance will be made to include some very large hospitals (10%, 7) to recruit 50 patients per phase, and smaller hospitals (10%, 7) to recruit 8 patients per phase, in order to allow a broad range of hospitals with variable experience and systems of care for the management of AIS.

Study Type

Interventional

Enrollment (Estimated)

7200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2065
    • New South Wales
    • Queensland
    • Western Australia
  • Chile
      • Osorno, Chile, 5290000
      • Valparaíso, Chile, 2352499
    • Los Lagos
      • Puerto Montt, Los Lagos, Chile
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile
        • Recruiting
        • Clinica Alemana de Santiago
        • Contact:
      • Santiago, Región Metropolitana, Chile
        • Recruiting
        • Hospital del Pino
        • Contact:
      • Santiago, Región Metropolitana, Chile
      • Santiago, Región Metropolitana, Chile
      • Santiago, Región Metropolitana, Chile
  • China
      • Shenyang, China
  • Malaysia
      • Kota Bharu, Malaysia, 16150
        • Recruiting
        • Hospital Universiti Sains Malaysia
        • Contact:
      • Kuala Lumpur, Malaysia, 56000
        • Recruiting
        • Universiti Kebangssan Malaysia Medical Center
        • Contact:
      • Serdang, Malaysia, 43400
        • Recruiting
        • Hospital Pengajar Universiti Putra Malaysia (Hpupm)
        • Contact:
  • Mexico
      • Ciudad de Mexico, Mexico
        • Recruiting
        • Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
        • Contact:
      • Puebla, Mexico
        • Recruiting
        • Hospital Regional ISSSTE de Puebla
        • Contact:
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
      • Chester, United Kingdom, CH2 1UL
        • Recruiting
        • Countess of Chester Hospital
        • Contact:
      • Exeter, United Kingdom, EX2 5DW
      • London, United Kingdom, SE5 9RS
      • London, United Kingdom, NW1 2PG
      • London, United Kingdom, LE1 5WW
        • Recruiting
        • Leicester Royal Infirmary
        • Contact:
          • Jatinder Minhas
      • London, United Kingdom, SW17 0QT
        • Recruiting
        • St George's University Hospitals
        • Contact:
          • Gillian Cluckie
      • Luton, United Kingdom, LU4 0DZ
      • Nottingham, United Kingdom, NG5 1PB
      • Oxford, United Kingdom, OX3 9DU
      • Peterborough, United Kingdom, PE3 9GZ
  • United States
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Completed
        • Centura St. Anthony Hospital
      • Littleton, Colorado, United States, 80122
        • Completed
        • Centura Littleton Adventist Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Completed
        • University of Maryland Medical Center
      • Baltimore, Maryland, United States, 21287
        • Completed
        • The John Hopkins Hospital
      • Columbia, Maryland, United States, 21044
        • Completed
        • Howard County General Hospital
    • Massachusetts
      • Worcester, Massachusetts, United States, 01601
        • Completed
        • University of Massachusetts Worcester
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Completed
        • Henry Ford Health System
      • Novi, Michigan, United States, 48374
        • Completed
        • Ascension Providence Hospital
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • Completed
        • SSM Health DePaul Hospital
      • Kansas City, Missouri, United States, 64132
        • Completed
        • Research Medical Center
      • Kansas City, Missouri, United States, 64111
        • Completed
        • Saint Luke's Hospital of Kansas City
    • Nevada
      • Reno, Nevada, United States, 89502
        • Completed
        • Renown Health
    • New York
      • Rochester, New York, United States, 14642
        • Completed
        • University of Rochester Medical Center
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Completed
        • Cone Health
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Completed
        • OhioHealth Research Institute - Riverside Methodist Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
        • Completed
        • Integris Southwest Medical Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Completed
        • Lehigh Valley Health Network
      • Hershey, Pennsylvania, United States, 17033
        • Completed
        • Penn State Health
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Completed
        • Inova Fairfax Hospital
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare Regional Medical Center Appleton
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 90
Measures of hospital costs
Time Frame: day 90
to allow economic analysis of treatment interventions at a country level
day 90
any serious adverse event during follow-up
Time Frame: Within 90 days
Within 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Craig Anderson

Collaborators

Johns Hopkins University
Genentech, Inc.
The George Institute for Global Health, Australia

Investigators

  • Principal Investigator: Craig S Anderson, MD PhD, The George Institute
  • Principal Investigator: Victor C Urrutia, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2021

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

November 6, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPTIMISTmain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Time Frame

12 months after primary results publication

IPD Sharing Access Criteria

Request with protocol to the Research Office of The George Institute

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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