Direct Transfer vs Conventional Triage for Stroke

(DIRECT Trial)

Overseen By Santiago Ortega, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Santiago Ortega Gutierrez

Disqualifiers: Hemorrhagic stroke, others

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate upon hospital arrival

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods for treating large vessel occlusion strokes. Researchers aim to determine if taking patients directly to the angiography suite for mechanical thrombectomy (clot removal) is more effective than the standard approach, which begins with an emergency room evaluation. The direct transfer to the angiography suite (DTAS) seeks to assess whether this method leads to faster recovery and reduced disability. The study targets individuals who exhibit severe stroke symptoms within 7 hours of onset. As an unphased trial, it provides patients the chance to contribute to innovative research that could enhance stroke treatment methods.

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 prior data suggests that this protocol is safe for stroke patients?

Research has shown that the Direct Transfer to Angiography Suite (DTAS) method is generally safe for treating strokes caused by large blood vessel blockages. Studies have found that DTAS can speed up hospital processes and increase the likelihood of receiving a procedure to remove the blockage. This method has been linked to reducing the severity of disabilities after a stroke.

At 24 hours after treatment, patients treated with the DTAS method had lower scores on a scale measuring stroke severity, with more patients showing significant improvement compared to the traditional method. This suggests that the DTAS approach is not only effective but also well-tolerated.

Overall, existing research supports the safety of the DTAS method, demonstrating it as an effective and safe way to manage stroke treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Direct Transfer to Angiography Suite (DTAS) approach for stroke because it offers a potentially faster route to treatment. Unlike the conventional method, where patients first undergo evaluation in the emergency department before being transferred for thrombectomy, DTAS bypasses the emergency department altogether. This direct transfer method aims to speed up the process by using flat panel CT imaging right in the angiography suite to quickly confirm eligibility for treatment. By reducing delays, DTAS could lead to better outcomes, less disability, and more efficient use of healthcare resources for stroke patients.

What evidence suggests that these triage strategies could be effective for stroke?

In this trial, one group of patients will undergo direct transfer to the angiography suite (DTAS), a method that research has shown can lead to better recovery for stroke patients. This approach helps patients regain movement and independence more effectively. Specifically, patients using DTAS were 53% more likely to have their blood flow restored after a blockage compared to those treated the usual way. Additionally, DTAS improves health outcomes and lowers treatment costs. Overall, bypassing the emergency room can speed up treatment and enhance recovery for stroke patients. ^{3 5 6 7 8}

Who Is on the Research Team?

Santiago Ortega, MD

Principal Investigator

University of Iowa

Tudor Jovin, MD

Principal Investigator

Cooper University Health Care

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Conventional Triage Arm Active Control 1 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) Arm Active Control 1 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.

Who Is Running the Clinical Trial?

Santiago Ortega Gutierrez

Lead Sponsor

Trials

1

Recruited

2,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10491438/

Cost-effectiveness of Direct Transfer to Angiography Suite of ... Recently, the strategy of direct transfer of patients with suspected LVO to the angiography suite (DTAS) has been shown to improve functional outcomes. This ...

2. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2782751

Direct to Angiography Suite Without Stopping for ... In conclusion, findings from this randomized clinical trial indicate that DTAS within 6 hours of symptom onset improved functional outcomes ...

3. jnis.bmj.com jnis.bmj.com/content/16/2/138

Cost-utility of direct transfer to angiography suite (DTAS ... Conclusions For patients with LVO admitted within 6 hours after symptom onset, the DTAS not only improves clinical outcome but also decreases the costs ( ...

4. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.118.021989

Direct Transfer to Angio-Suite to Reduce Workflow Times ... A case-control matched study of the first 79 DTAS patients with confirmed large vessel occlusion (cases) and 145 no-DTAS patients (controls).

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0967586825000827

Direct transfer to angiosuite vs conventional workup for stroke Patients who triaged DTAS were 53% more likely to achieved successful recanalization (mTICI 2b-3) following the thrombectomy compared to CWU. •. There was no ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8329790/

Direct to Angiography Suite Without Stopping for Computed ... The use of a DTAS protocol improved in-hospital workflow times, increased the rate of endovascular treatment, and decreased the severity of disability.

7. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.118.021989?platform=hootsuite

Direct Transfer to Angio-Suite to Reduce Workflow Times ... At 24 hours, DTAS patients presented lower NIHSS score (7 [4–16] versus 14 [4–20]; P=0.01), higher rate of dramatic improvement (50.6% Vs. 31.7%; P=0.04), and ...

8. neurology.org neurology.org/doi/10.1212/WNL.0000000000012799

Direct Transfer to Angiosuite in Acute Stroke Time to reperfusion is one of the strongest predictors of functional outcome in acute stroke due to a large vessel occlusion (LVO). Direct transfer to ...