Optimizing the Prehospital Use of Stroke Systems of Care-Reacting to Changing Paradigms-Implementation (OPUS-i)

NCT06530693 | Recruiting

• 1 other identifier: 30716
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

Brief Summary

This interventional trial will compare a novel prehospital stroke transport algorithm (OPUS-i) to a traditional prehospital stroke transport algorithm to improve outcomes in rural stroke patients by determining the effect of implementing a data-driven prehospital stroke algorithm on time to and endovascular therapy. The study consists of a multicenter cohort and will last 24 months but individual subject study duration is 90 days.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Time from stroke onset to endovascular therapy

  This outcome will assess process measures for acute stroke patients

  From time of stroke onset to endovascular therapy, assessed on day 0 of admission

Secondary Outcomes (28)

• Time from stroke onset IVT

  From time of stroke onset to IVT, Assessed on day 0 of admission

• Rate of bypass of non-ESCs for rural and urban patients.

  The percentage of patients bypassed from non-ESCs to ESCs, assessed on day 0 of admission

• Rate of bypass of non-ESCs for rural and urban patients.

  Modified Rankin Scale of 0-2 at 90 days in patients for all stroke patients.

• To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in LVOS

  Modified Rankin Scale of 0-2 at 90 days in patients with large vessel occlusion stroke.

• To evaluate the effect of a novel prehospital stroke transport algorithm on stroke outcomes in patients with LVOS

  Modified Rankin Scale of 0-2 at 90 days for patients with intracranial hemorrhage

Study Arms (2)

Standard transport protocol

ACTIVE COMPARATOR

Standard EMS stroke transport protocol

Other: OPUS-i algorithm

OPUS-i Protocol

ACTIVE COMPARATOR

OPUS-i protocol

Other: OPUS-i algorithm

Interventions

OPUS-i algorithm OTHER

A novel pre-hospital algorithm.

OPUS-i Protocol; Standard transport protocol

Eligibility Criteria

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

You may qualify if:

• Clinical impression of stroke/TIA by EMS clinicians

You may not qualify if:

• Age \< 18 years
• Prisoner

Sponsors & Collaborators

• Temple University: lead
• Cooper University Health Care: collaborator
• Geisinger Medical Center, Danville, PA: collaborator
• Thomas Jefferson University: collaborator

Study Sites (2)

Cooper University Health

Camden, New Jersey, 08103, United States

RECRUITING

3401 N Broad street

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Derek Isenberg, MD

  Lewis Katz School of Medicine at Temple University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Derek Isenberg, MD

CONTACT

2157077550; derek.isenberg@tuhs.temple.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 31, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year after study completion

Locations

US (2)