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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for transporting stroke patients to the hospital, focusing on those in rural areas. The researchers aim to determine if the OPUS-i transport method delivers treatment faster than the usual method. The study will compare the new protocol to the standard one used by emergency services. Eligible participants are those identified by emergency medical staff as having a stroke or TIA (a temporary stroke-like event). As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions that could enhance emergency care for stroke patients.

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 prior data suggests that this transport method is safe for stroke patients?

Research has shown that the OPUS-i protocol is a new method for transporting stroke patients, developed using real-world data on those with a type of stroke involving a blocked large artery.

Although specific safety data for the OPUS-i protocol is not available, it is part of prehospital stroke care and likely adheres to existing safe practices. Generally, changes in patient transport aim to improve outcomes by speeding up treatment, which can enhance recovery without introducing new risks.

Overall, despite the lack of specific safety data for OPUS-i, new medical protocols are typically tested carefully to ensure safety. The primary goal is to improve the speed and effectiveness of patient care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OPUS-i Protocol because it offers a new approach to transporting stroke patients. Unlike the standard EMS stroke transport protocol, which follows traditional methods, the OPUS-i Protocol is designed to optimize the speed and efficiency of getting patients to the care they need. This innovative protocol could significantly improve outcomes by reducing the time between a stroke event and treatment, potentially saving lives and reducing the severity of stroke impacts.

What evidence suggests that the OPUS-i protocol is effective for stroke transport?

This trial will compare the OPUS-i Protocol with the standard transport protocol for stroke care. Research has shown that OPUS-i uses a data-driven method to enhance stroke care before patients reach the hospital. The OPUS-REACH registry gathers detailed patient information from the time emergency services are called until 90 days after the stroke. This comprehensive data collection aims to improve treatment timing, which is crucial for stroke recovery. The method emphasizes quickly identifying and treating major blockages in brain arteries to increase recovery chances. While more detailed human data is still being collected, this focus on reducing treatment time could potentially benefit stroke patients in rural areas. ^{1 2 3 6 7}

Who Is on the Research Team?

Derek Isenberg, MD

Principal Investigator

Lewis Katz School of Medicine at Temple University

Are You a Good Fit for This Trial?

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

I am under 18 years old.

Prisoner

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8988419/

Optimizing Prehospital Stroke Systems of Care-Reacting to ... Unlike prior research, the OPUS-REACH registry contains patient-level data spanning from EMS dispatch to ninety day functional outcomes.

2. researchgate.net researchgate.net/publication/359801003_Optimizing_Prehospital_Stroke_Systems_of_Care-Reacting_to_Changing_Paradigms_OPUS-REACH_a_pragmatic_registry_of_large_vessel_occlusion_stroke_patients_to_create_evidence-based_stroke_systems_of_care_a

Optimizing Prehospital Stroke Systems of Care-Reacting ... Unlike prior research, the OPUS-REACH registry contains patient-level data spanning from EMS dispatch to ninety day functional outcomes. We expect that we will ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35392840/

Optimizing Prehospital Stroke Systems of Care-Reacting to ... Unlike prior research, the OPUS-REACH registry contains patient-level data spanning from EMS dispatch to ninety day functional outcomes.

4. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.122.039586

Prehospital Stroke Care Part 1: Emergency Medical ... This topical review provides an overview of the state of the science on prehospital components of stroke systems of care and how emergency medical services ...

5. europepmc.org europepmc.org/article/pmc/pmc8686821

Trauma Communications Center Coordinated Severity ... The primary outcome is change in the proportion of prehospital stroke system patients with suspected LVO who are treated with mechanical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10589426/

Transport Strategy in Patients With Suspected Acute Large ... Patients eligible for intravenous thrombolysis (IVT) who were suspected for large vessel occlusion were randomized 1:1 to admission to the nearest PSC.

7. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.039792

Prehospital Stroke Care Part 2: On-Scene Evaluation and ... This topical review discusses the current state of prehospital acute stroke screening and transport, as well as new and emerging advances in prehospital ...