New Transport Method for Stroke

(OPUS-i Trial)

Overseen By Derek Isenberg, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Temple University

Disqualifiers: Age < 18, Prisoner

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 90 days

360 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment OPUS-i for stroke?

The research highlights the importance of rapid transport and treatment for stroke patients, which is crucial for the effectiveness of any stroke treatment. The pilot study demonstrated that a new transport protocol significantly reduced transfer time for stroke patients, which can improve outcomes when combined with effective treatments like OPUS-i. ^{1 2 3 4 5}

Research Team

Derek Isenberg, MD

Principal Investigator

Lewis Katz School of Medicine at Temple University

Eligibility Criteria

This trial is for stroke patients in rural areas. It's testing if a new prehospital transport method (OPUS-i algorithm) can get them to treatment faster than the old way. Participants must be within the study's regional boundaries and able to follow up.

Inclusion Criteria

Clinical impression of stroke/TIA by EMS clinicians

Exclusion Criteria

Prisoner

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implementation of the OPUS-i prehospital stroke transport algorithm to improve outcomes for stroke patients

90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Treatment Details

Interventions

• OPUS-i

Trial Overview The OPUS-i trial is comparing a new data-driven algorithm for transporting stroke patients against traditional methods, focusing on how quickly they receive endovascular therapy over a 90-day period per patient.

Participant Groups

Group I: Standard transport protocol Active Control 1 Intervention

Standard EMS stroke transport protocol

Group II: OPUS-i Protocol Active Control 1 Intervention

Experimental OPUS-i protocol

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials

321

Recruited

89,100+

References

1. Poland pubmed.ncbi.nlm.nih.gov

Transport strategy for ischaemic stroke patients with large vessel occlusion. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

In-Transit Telemedicine Speeds Ischemic Stroke Treatment: Preliminary Results. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

A novel emergency medical services protocol to improve treatment time for large vessel occlusion strokes. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Economic Evaluation of a Mobile Stroke Unit Service in Germany. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Management of Acute Ischemic Stroke Due to Large-Vessel Occlusion: JACC Focus Seminar. [2020]