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Compensation: Varies

Number of Visits: 1

Duration: Immediate upon hospital arrival

2039 Participants Needed

Direct Transfer vs Conventional Triage for Stroke
(DIRECT Trial)

Overseen BySantiago Ortega, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Santiago Ortega Gutierrez

Disqualifiers: Hemorrhagic stroke, others

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

Trial Summary

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Direct Transfer to Angiography Suite (DTAS) for stroke?

Research shows that DTAS can improve outcomes for stroke patients by reducing the time to treatment, which is crucial for minimizing brain damage. Studies found that patients transferred directly to the angiography suite had faster treatment times and better recovery outcomes compared to those who went through conventional triage processes.¹ ² ³ ⁴ ⁵

Is Direct Transfer to Angiography Suite (DTAS) safe for stroke patients?

Research indicates that Direct Transfer to Angiography Suite (DTAS) is generally safe for stroke patients, with a lower rate of complications like symptomatic hemorrhagic transformation (bleeding in the brain) compared to conventional triage methods.¹ ² ³ ⁶ ⁷

How does the Direct Transfer to Angiography Suite (DTAS) treatment for stroke differ from other treatments?

The Direct Transfer to Angiography Suite (DTAS) treatment for stroke is unique because it involves taking patients directly to the angiography suite for treatment without stopping for initial imaging tests like a CT scan. This approach aims to reduce the time to treatment, potentially improving outcomes by allowing faster access to endovascular therapy, which is crucial for patients with large vessel occlusion strokes.¹ ³ ⁴ ⁶ ⁸

What is the purpose of this trial?

The purpose of this study is to compare two strategies for treating adults with suspected large vessel occlusion stroke within 7 hours of symptom onset. Researchers will evaluate whether direct transfer to the neurointerventional angiography suite improves recovery and reduces disability compared to the conventional approach of first being evaluated in the emergency department. The study will also assess safety and other health outcomes to guide care for stroke patients.

Research Team

Santiago Ortega, MD

Principal Investigator

University of Iowa

Tudor Jovin, MD

Principal Investigator

Cooper University Health Care

Eligibility Criteria

Adults who've had a stroke caused by a large vessel blockage in the brain within the past 7 hours can join. The trial is testing if going straight to an angiography suite helps more than the usual emergency room evaluation first.

Inclusion Criteria

Baseline NIHSS of 10 or higher

I arrived at the treatment center within 7 hours of my last known well time.

I have signed the consent form, or my legal representative has.

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Exclusion Criteria

Presentation to a thrombectomy-capable center more than 7 hours from LSW

At sites enrolling transfer patients, any patient arriving from an outside hospital with time from imaging study at the presenting hospital to arrival at the TSC within 90 minutes

I have bleeding in my brain that makes certain stroke treatments unsafe.

See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either direct transfer to the neurointerventional angiography suite or conventional evaluation in the emergency department followed by mechanical thrombectomy if eligible

Immediate upon hospital arrival

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of global disability, functional independence, and quality of life

90 days

Multiple assessments (in-person and virtual)

Long-term Follow-up

Additional monitoring of health outcomes and healthcare utilization, including mortality and caregiving burden

90 days

Treatment Details

Interventions

Direct Transfer to Angiography Suite (DTAS)

Trial Overview The study compares two methods: one where patients are directly taken to an angiography suite for potential clot removal, and another where they go through standard ER assessment before any procedures.

Participant Groups

2Treatment groups

Active Control

Group I: Conventional Triage ArmActive Control1 Intervention

In this arm, patients with suspected large vessel occlusion (LVO) stroke undergo an initial evaluation in the emergency department (ED), including standard imaging, to confirm eligibility for mechanical thrombectomy (MT). Once eligibility is confirmed, they are transferred to the neurointerventional suite for further treatment. This strategy represents the traditional approach used in many stroke centers and serves as a comparator to the direct transfer strategy. The outcomes measured in this arm will be compared to those in the Direct Transfer to Angiography Suite (DTAS) arm to assess the relative effectiveness and safety of both triage strategies.

Group II: Direct Transfer to Angiography Suite (DTAS) ArmActive Control1 Intervention

Description: In this arm, patients with suspected large vessel occlusion (LVO) stroke are directly transferred to the neurointerventional angiography suite without initial evaluation in the emergency department. Neuroimaging is performed using flat panel CT (FPCT) to confirm treatment eligibility for mechanical thrombectomy (MT). This strategy aims to reduce delays in treatment and improve clinical outcomes by bypassing the emergency department, leading to faster access to thrombectomy. This arm will assess the effectiveness and safety of direct transfer, comparing it to the conventional triage strategy in terms of disability outcomes, safety, and healthcare utilization.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Santiago Ortega Gutierrez

Lead Sponsor

Trials

Recruited

2,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

The direct-to-angiography suite (DTAS) pathway for suspected stroke patients showed a modest reduction in door-to-reperfusion times, saving between 0.2 to 3.5 minutes compared to the conventional CT pathway, based on a simulation model using two years of observational data.

However, the effectiveness of the DTAS pathway is highly sensitive to the baseline utilization of angiography suites, indicating that even a small increase in usage could negate the time savings, suggesting that further research is needed to evaluate its clinical implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of direct-to-angiography suite (DTAS) and conventional clinical pathways in stroke care: a simulation study.Bastani, M., White, TG., Martinez, G., et al.[2023]

Rapid reperfusion therapy, such as intravenous thrombolytics and endovascular thrombectomy, significantly improves outcomes in acute ischemic stroke, with every minute saved potentially preserving up to 27 million neurons.

The emerging 'direct to angio' approach aims to streamline patient triage and treatment, potentially reducing the time to reperfusion therapy, though its safety, efficacy, and feasibility are still under review.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct Transfer to the Neuroangiography Suite for Patients With Stroke.Desai, SM., Psychogios, M., Khatri, P., et al.[2023]

Direct transfer to the angio-suite (DTAS) for patients with suspected large vessel occlusion stroke significantly reduced workflow times, with median door-to-groin times of 16 minutes compared to 70 minutes for controls.

Patients in the DTAS group showed better clinical outcomes, including a lower NIHSS score at 24 hours and a higher rate of favorable outcomes at 90 days, with an odds ratio of 2.5 for achieving a favorable outcome compared to controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct Transfer to Angio-Suite to Reduce Workflow Times and Increase Favorable Clinical Outcome.Mendez, B., Requena, M., Aires, A., et al.[2019]