Stroke, Acute
Conditions
Keywords
Large Vessel Occlusion, Acute Ischemic Stroke, Pragmatic Clinical Trial
Brief summary
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.
Detailed description
Large vessel occlusion (LVO) strokes are among the most severe types of strokes, caused by a blockage in one of the brain's major blood vessels. These strokes can lead to significant disability or death without prompt treatment. Mechanical thrombectomy (MT), a procedure that physically removes the clot, is one of the most effective treatments for LVO strokes. However, there is still uncertainty about the best way to quickly triage and prepare patients for MT to achieve the best outcomes. This study, called the DIRECT trial, aims to compare two common triage strategies for patients suspected of having an LVO stroke: Direct transfer to the neurointerventional angiography suite - In this strategy, patients are taken straight to the neurointerventional suite upon arrival at the hospital. Advanced imaging and treatment decisions are made immediately, potentially speeding up treatment. Conventional evaluation in the emergency department (ED) - In this approach, patients undergo initial evaluation and imaging in the ED before being transferred to the neurointerventional suite if they are eligible for MT. The main goal of this study is to determine if bypassing the ED and directly transferring patients to the neurointerventional suite leads to better recovery and reduced disability at 90 days compared to the conventional strategy. Researchers will also assess other important outcomes, including safety (such as the risk of brain bleeding), quality of life after the stroke, efficiency of stroke care, and the use of healthcare resources (such as hospital stay length). The study will include approximately 2,039 adult patients aged 18 and older who are suspected of having an LVO stroke. To participate, patients must arrive at one of the participating thrombectomy-capable stroke centers within 7 hours of symptom onset. These centers are equipped to perform advanced stroke care, including MT. Participants in the trial will represent a diverse population reflective of the general community affected by stroke. The trial will take place at 20 hospitals across the United States, all with high experience in treating stroke patients. The study will help provide critical insights into which triage strategy offers the best outcomes for patients with LVO strokes and improve future care for these emergencies.
Interventions
OTHERConventional Triage for Mechanical Thrombectomy
Participants undergo the conventional standard-of-care triage process. Upon arrival at the thrombectomy-capable center, patients first undergo an initial evaluation in the emergency department (ED), which includes diagnostic imaging (CT or MRI) to confirm eligibility for mechanical thrombectomy (MT). If the patient is found to have a large vessel occlusion (LVO) suitable for thrombectomy, they are transferred to the neurointerventional suite for treatment.
OTHERDirect Transfer to Angiography Suite (DTAS
Patients who arrive at the thrombectomy-capable center (from home, mobile stroke units, or interfacility transfer) are immediately transferred to the neurointerventional suite, bypassing the emergency department (ED). Upon arrival in the neurointerventional suite, initial neuroimaging (typically using flat panel CT or other imaging modalities) is conducted to confirm the presence of a large vessel occlusion (LVO). If the patient is eligible for mechanical thrombectomy (MT), treatment is initiated directly in the angiography suite. This approach aims to reduce delays in care and improve clinical outcomes by providing faster access to thrombectomy treatment.
Sponsors
Santiago Ortega Gutierrez
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Data Analysts: Individuals analyzing the data may also be blinded to the treatment assignment to avoid bias in data interpretation
Intervention model description
This study employs a cluster-randomized crossover design, where thrombectomy-capable stroke centers (clusters) are randomized to adopt one of two standard-of-care triage strategies: direct transfer to the neurointerventional angiography suite or conventional emergency department evaluation. Each cluster transitions between strategies at predefined intervals of two weeks. This design ensures all centers implement both approaches, enabling a robust comparison of clinical outcomes while accommodating site-specific workflows and variability.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be eligible for participation in the DIRECT trial, an individual must meet all of the following criteria: 1. Age: ≥ 18 years of age. 2. Clinical Presentation: Present to a participating TSC with signs or symptoms suggestive of acute LVO stroke. 3. Stroke Severity: Baseline NIHSS of 10 or higher. 4. Time since LKW: Time from LKW to arrival at the TSC must be within 7 hours. Additional criteria For all Interfacility Transfers: 1\. If imaging was performed at the outside facility, the time from the first imaging to arrival at the thrombectomy center must exceed 90 minutes. For all the Conventional Triage Arm, participants must also meet the following criteria: 1. Presence of a qualifying LVO by CTA or MRA imaging; or 2. For Large Core Patients: Patients with large core infarcts (CT-ASPECT score ≤ 5, DWI-ASPECT score ≤ 5, or infarct volume ≥ 70 cc) will be enrolled, irrespective of treatment decisions regarding embolectomy. For all DTAS Arm: 1\. Patients who do not have LVO occlusions in the angiography suite assessment (ICH, distal occlusions or mimics) will be enrolled, irrespective of treatment decisions regarding embolectomy.
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in the trial: 1. Time Restrictions: Presentation to a thrombectomy-capable center more than 7 hours from LSW. 2. Imaging Criteria for Interfacility Transfer Patients: 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 not exceeding 90 minutes. 3. Hemorrhagic Stroke: Presence of intracranial hemorrhage on brain imaging in the conventional strategy as Heidelberg that renders thrombectomy contraindicated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Disability at 90 Days | 90 days (±14 days) | Global disability will be measured using the disability-weighted modified Rankin Scale (dw-mRS) at 90 days (±14 days) post-stroke. The dw-mRS is a validated tool assessing the severity of disability across seven levels, from no symptoms (0) to severe disability or death (6). This outcome evaluates whether the direct transfer to the angiography suite (DTAS) strategy results in improved functional outcomes compared to the conventional triage strategy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Independence at 90 Days | 90 (±14) days. | The proportion of patients achieving functional independence, measured by a dichotomized modified Rankin Scale score (mRS 0-2), assessed during the in-hospital stay and at 90 (±14) days after treatment. |
| Stroke Workflow Efficiency | Immediately post procedure | Metrics include door-to-puncture times, door-to-reperfusion times, and rates of intravenous thrombolysis administration, evaluating the time taken to perform key steps in stroke workflow. |
| Procedural Success | Immediately post-procedure. | Reperfusion rates of the large vessel occlusion (LVO) using the Extended Thrombolysis in Cerebral Ischemia (eTICI) scale, with successful reperfusion defined as mTICI 2b-3. |
| Cognitive Ability | 90 (±14) days. | Assessed at 90 days using the Montreal Cognitive Assessment (MoCA), measuring domains such as memory, attention, and executive function. |
| Health-Related Quality of Life | 90 (±14) days. | HR-QoL evaluated using PROMIS GH-10 and EQ-5D-5L to assess overall health and well-being at 90 days. |
Countries
United States
Contacts
CONTACTSantiago Ortega, MD
CONTACTCarlos A Contreras Mesa, MSc
PRINCIPAL_INVESTIGATORSantiago Ortega, MD
University of Iowa
PRINCIPAL_INVESTIGATORTudor Jovin, MD
Cooper University Health Care
Outcome results
None listed