Recruiting

OPUS-i vs. Traditional

Sponsor:

Temple University

Code:

NCT06530693

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OPUS-i algorithm

Study Details

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

Study ID

NCT06530693

Start date

Apr 1, 2025

Status verified date

Mar, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Clinical impression of stroke/TIA by EMS clinicians

Exclusion Criteria:

  • Age < 18 years
  • Prisoner

Study Design

Enrollment

360 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Standard transport protocol

Standard EMS stroke transport protocol

active comparator: OPUS-i Protocol

OPUS-i protocol

Interventions

OPUS-i algorithm

A novel pre-hospital algorithm.

Primary outcome measure

  • Time from stroke onset to endovascular therapy [ Time Frame: From time of stroke onset to endovascular therapy, assessed on day 0 of admission ]

Central Contacts and Locations

Central contacts

Derek Isenberg, MD

2157077550derek.isenberg@tuhs.temple.edu

Locations

Cooper University Health

Recruiting

Camden, New Jersey, United States, 08103

3401 N Broad street

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Derek Isenberg, MD

215-707-8020derek.isenberg@tuhs.temple.edu

More Information

Sponsor

Temple University

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Temple University on 2026-03-12.