Optimal Post Tpa-Iv Monitoring in Ischemic Stroke

Completed · Not applicable

Conditions studied: Acute Ischemic Stroke Patients Receiving Reperfusion Therapy

In brief

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.

Key facts

Study ID

NCT03734640

Run by

Craig Anderson

People needed

4922

Starts

2021-04-28

Expected to finish

2025-01-23

Last updated by the study team

2025-03-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Centura Littleton Adventist Hospital — Littleton, Colorado, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• The John Hopkins Hospital — Baltimore, Maryland, United States
• Howard County General Hospital — Columbia, Maryland, United States
• University of Massachusetts Worcester — Worcester, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Ascension Providence Hospital — Novi, Michigan, United States
• SSM Health DePaul Hospital — Bridgeton, Missouri, United States
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• Research Medical Center — Kansas City, Missouri, United States
• Renown Health — Reno, Nevada, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Cone Health — Greensboro, North Carolina, United States
• OhioHealth Research Institute - Riverside Methodist Hospital — Columbus, Ohio, United States
• INTEGRIS Southwest Medical Center — Oklahoma City, Oklahoma, United States
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States
• Penn State Health — Hershey, Pennsylvania, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• ThedaCare Regional Medical Center Appleton — Appleton, Wisconsin, United States
• Canberra Hospital — Canberra, Australian Capital Territory, Australia
• Concord Hospital — Concord, New South Wales, Australia
• Nepean Hospital — Kingswood, New South Wales, Australia
• St George Public Hospital — Kogarah, New South Wales, Australia
• Prince of Wales Hospital — Randwick, New South Wales, Australia
• Centura St. Anthony Hospital — Lakewood, Colorado, United States

Full record on ClinicalTrials.gov

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