StrokeNCT06024330
External Validation of VAN, VES and LARIO Scales in Suspected Acute Stroke
An observational study of Stroke, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
In acute ischemic stroke, treatments include intravenous thrombolysis (IVT) and mechanical thrombectomy (MT). IVT is viable up to 4.5 hours post-stroke onset, while MT is applicable within 24 hours but primarily for large vessel occlusions. MT is specialized and performed in select stroke centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- VAN assessment, VES assessment and LARIO assessment
- How many people
- 614 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Nov 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All eligible patients with a suspicion of stroke who were admitted to the ED by EMS.
Who may be able to join
- Adult patients admitted to the ED with the suspicion of stroke by EMS.
Who cannot join
- More than 24 hours have passed since the onset of symptoms or the last known normal in the patient.
- The emergency physician does not indicate the need for imaging like Computerized Tomography (CT), CT Angiography (CTA), Diffusion-Weighted Magnetic Resonance Imaging (DWI-MRI), or Magnetic Resonance Angiography (MRA), or the imaging test cannot be performed.
- Exacerbation of residual symptoms due to a previous hemorrhagic or ischemic stroke.
- Conditions in the ED that prevent scale assessment (e.g., advanced airway needs, the patient's non-cooperation with the examination, immediate resuscitation need, etc.).
- Patients transferred to ED after being diagnosed at another healthcare institution.
- Pregnant patients
- Non-consenting patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Validation of the VAN, VES, and LARIO Scoring Systems in Patients Suspected of Acute Stroke in Emergency Triage: A Multicenter Prospective Cross-sectional Study
In acute ischemic stroke, treatments include intravenous thrombolysis (IVT) and mechanical thrombectomy (MT). IVT is viable up to 4.5 hours post-stroke onset, while MT is applicable within 24 hours but primarily for large vessel occlusions. MT is specialized and performed in select stroke centers. Effective early triage improves neurological outcomes. Pre-hospital stroke severity assessment and direct transfers for MT are crucial. Although the National Institute of Health Stroke Scale (NIHSS) is widely recognized, its practicality is limited in emergency settings due to its complexity. Alternative scoring systems like LAMS, CPSS, and RACE have been introduced but have limitations. Recently developed scores, namely Vision, Aphasia, and Neglect (VAN), Ventura Emergency Large Vessel Occlusion (VES), and Large Artery Intracranial Occlusion Stroke Scale (LARIO), demonstrate promising diagnostic accuracy in pilot studies, suggesting potential benefits for early detection, appropriate triage, and better neurological outcomes
Read the detailed description
For acute ischemic stroke, time-dependent treatments include intravenous thrombolysis (IVT) and mechanical thrombectomy (MT). IVT can be considered in all patients with acute ischemic stroke within the first 4.5 hours after the last known well time. However, MT can only be applied within the first 24 hours in large vessel occlusions defined as acute occlusion of the intracranial internal carotid artery (ICA), proximal posterior, middle, and anterior cerebral arteries (respectively PCA, MCA, ACA), intracranial vertebral artery and/or basilar artery. However, MT can only be performed in stroke centers specialized in this area. Effective triage of large vessel occlusion and early application of emergency stroke protocols are associated with good neurological outcomes. In this sense, pre-hospital determination of stroke severity and direct transfer of patients requiring MT to the stroke center are recommended by current guidelines. It is important that the protocols used in pre-hospital and emergency department triage to determine stroke severity are easy to learn and apply, are repeatable, and their accuracy is proven with external data sets. To date, many scoring systems have been proposed for early determination of stroke severity. Although the most accepted and widely used system among these systems is the National Institute of Health Stroke Scale (NIHSS), the need for training and experience for practitioners and the time-consuming application restrict its use in pre-hospital or emergency department triage. Alternatively, short and easily applicable systems such as The Los Angeles Motor Scale (LAMS), The Cincinnati Prehospital Stroke Scale (CPSS), Rapid Arterial oCclusion Evaluation (RACE) have been developed in the pre-hospital setting. However, the inability of these systems to provide high sensitivity and specificity together has necessitated the development of other alternative scoring systems. Among the new scoring systems developed in recent years, the Vision, Aphasia, and Neglect (VAN) score, the Ventura Emergency Large Vessel Occlusion (VES) score, and the Large Artery Intracranial Occlusion Stroke Scale (LARIO) have shown high diagnostic performance in pilot studies. The VAN score was shown to be 100% sensitive and 90% specific in predicting large vessel occlusion in stroke patients with motor weakness accompanied by at least one of the symptoms of vision, aphasia, and neglect or an NIHSS score of >6. The VES score was developed as a 4-step system evaluating eye deviation, aphasia, neglect, and lethargy, and it was reported that the presence of at least one of these functions was 95% sensitive and 82% specific in predicting large vessel occlusion. The LARIO score was developed as a 5-step system evaluating facial paralysis, speech disorder, arm weakness, hand grip weakness, and neglect. Having >3 of these steps positive provided 100% sensitivity and 82% specificity for large vessel occlusion. The results obtained from pilot studies suggest that the use of VAN, VES, and LARIO scoring systems in pre-hospital or emergency department triage promises to improve neurological outcomes by early identification of patients with large vessel occlusion requiring MT, appropriate triage, and optimal application of stroke protocols
- Conditions
- Stroke
- Being tested
- VAN assessment, VES assessment, LARIO assessment
- Keywords
- Triage, Emergency Departments, Stroke, Scales
- Medical subject headings
- Stroke, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAN assessmentDiagnostic test
An investigator assesses the VAN scale when a patient arrives at ED triage with a suspected stroke.
VES assessmentDiagnostic test
An investigator assesses the VES scale when a patient arrives at ED triage with a suspected stroke.
LARIO assessmentDiagnostic test
An investigator assesses the LARIO scale when a patient arrives at ED triage with a suspected stroke.
| Study group | Role | What they receive |
|---|---|---|
| Positive VAN scale | Motor Function: Check for arm drift with arms extended, palms up, and eyes closed for 10 seconds. If present, proceed to the VAN criteria.
V (Visual): Assess for reported double vision, field cut, or vision loss, or difficulty seeing fingers in a quadrant. If any visual disturbances are found, the patient is "VAN positive".
A (Aphasia): Identify difficulties forming words, repeating a short sentence, recognizing two objects, or following simple commands. If any aphasia symptoms are observed, the patient is "VAN positive".
N (Neglect): Check for forced gaze, inability to track a pen to one side, or lack of sensation in limbs. If any neglect signs are detected, the patient is "VAN positive". Receives: Diagnostic Test: VAN assessment | |
| Negative VAN scale | A negative VAN scale indicates that a potential stroke patient does not exhibit the primary signs associated with a large vessel occlusion (LVO). Specifically, the patient demonstrated no arm drift during the initial motor function test. If the motor assessment is proceeded to the VAN criteria, the patient shows no visual disturbances like double vision or field cuts ("V"), no aphasia symptoms such as difficulty forming words or repeating sentences ("A"), and no signs of neglect, like forced gaze or lack of sensation in limbs ("N") Receives: Diagnostic Test: VAN assessment | |
| Positive VES scale | Eye Deviation: Scored as 1 if there's a forced deviation of both eyes to any side; otherwise, scored as 0.
Aphasia: Scored as 1 if the patient is awake and exhibits one or more of the following:
Inability to repeat a sentence. Inability to name an object. Talking incoherently or not obeying commands. Being mute. Otherwise, scored as 0. Neglect: Scored as 1 if the patient can perceive touch on both sides individually but fails to feel it on one side when stimulated simultaneously. Otherwise, scored as 0.
Obtundation: Scored as 1 if the patient cannot maintain wakefulness during a conversation; otherwise, scored as 0.
The VES can range from 0 to 4. A score of 1 or higher suggests a positive likelihood for ELVO. Additionally, if a patient tests positive for aphasia, neglect can be deduced by noting if the patient disregards the examiner on one side but is responsive when the examiner switches sides. Receives: Diagnostic Test: VES assessment | |
| Negative VES scale | Eye Deviation: No forced deviation of both eyes is observed. Aphasia: The patient, while awake, can repeat sentences, name objects, speaks coherently, follows commands, and is not mute.
Neglect: The patient can perceive touch both when sides are stimulated individually and simultaneously.
Obtundation: The patient remains awake and alert during conversation. A total score of 0 on the VES scale represents a VES negative outcome. Receives: Diagnostic Test: VES assessment | |
| Positive LARIO scale | Facial Palsy: The presence of facial muscle weakness or paralysis scores 1, while a normal facial expression scores 0.
Arm Weakness: A score of 1 is given for arm drift, no effort against gravity, or no movement at all. No drift is scored 0.
Grip Strength: Reduced or absent grip strength scores 1, while a normal grip scores 0.
Language: Changes in speech, global aphasia, or the patient being mute results in a score of 1. Normal language is scored 0.
Neglect: A score of 1 is given if the patient exhibits extinction to bilateral simultaneous stimulation in one or more sensory modality, doesn't recognize their own hand, or consistently orients only to one side of the body. The absence of these signs scores 0.
A cumulative score exceeding 3 on the LARIO Stroke Scale categorizes the patient as "LARIO positive," Receives: Diagnostic Test: LARIO assessment | |
| Negative LARIO scale | Facial Palsy: No observable facial muscle weakness or paralysis. Arm Weakness: The arm remains steady without drift and exhibits normal effort against gravity.
Grip Strength: The patient displays normal grip strength. Language: The patient speaks normally, without aphasia or muteness. Neglect: No signs of sensory extinction upon bilateral simultaneous stimulation, proper recognition of their own hand, and balanced orientation to both sides of the body.
A cumulative score of 3 or less on the LARIO Stroke Scale classifies the patient as "LARIO negative," Receives: Diagnostic Test: LARIO assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of VAN for predicting ELVO
Sensitivity, specificity, PPV, NPV
Measured: 24 hours
Diagnostic performance of VES for predicting ELVO
Sensitivity, specificity, PPV, NPV
Measured: 24 hours
Diagnostic performance of LARIO for predicting ELVO
Sensitivity, specificity, PPV, NPV
Measured: 24 hours
Secondary outcomes (1)
Diagnostic performance of NIHSS for predicting ELVO
Sensitivity, specificity, PPV, NPV
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Jun 2023
- Primary completion1 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 614 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Ulas Ozturan, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024330
- Sponsor's protocol ID
- KU GOEK-2022/06.15
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2023
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of the VAN, VES, and LARIO Scoring Systems in Patients Suspected of Acute Stroke in Emergency Triage: A Multicenter Prospective Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06024330
- Acronym / sponsor ID
- KU GOEK-2022/06.15
- Conditions
- Stroke
- Keywords
- Triage, Emergency Departments, Stroke, Scales
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In acute ischemic stroke, treatments include intravenous thrombolysis (IVT) and mechanical thrombectomy (MT). IVT is viable up to 4.5 hours post-stroke onset, while MT is applicable within 24 hours but primarily for large vessel occlusions. MT is specialized and performed in select stroke centers. Effective early triage improves neurological outcomes. Pre-hospital stroke severity assessment and direct transfers for MT are crucial. Although the National Institute of Health Stroke Scale (NIHSS) is widely recognized, its practicality is limited in emergency settings due to its complexity. Alternative scoring systems like LAMS, CPSS, and RACE have been introduced but have limitations. Recently developed scores, namely Vision, Aphasia, and Neglect (VAN), Ventura Emergency Large Vessel Occlusion (VES), and Large Artery Intracranial Occlusion Stroke Scale (LARIO), demonstrate promising diagnostic accuracy in pilot studies, suggesting potential benefits for early detection, appropriate triage, and better neurological outcomes
Detailed description
For acute ischemic stroke, time-dependent treatments include intravenous thrombolysis (IVT) and mechanical thrombectomy (MT). IVT can be considered in all patients with acute ischemic stroke within the first 4.5 hours after the last known well time. However, MT can only be applied within the first 24 hours in large vessel occlusions defined as acute occlusion of the intracranial internal carotid artery (ICA), proximal posterior, middle, and anterior cerebral arteries (respectively PCA, MCA, ACA), intracranial vertebral artery and/or basilar artery. However, MT can only be performed in stroke centers specialized in this area. Effective triage of large vessel occlusion and early application of emergency stroke protocols are associated with good neurological outcomes. In this sense, pre-hospital determination of stroke severity and direct transfer of patients requiring MT to the stroke center are recommended by current guidelines. It is important that the protocols used in pre-hospital and emergency department triage to determine stroke severity are easy to learn and apply, are repeatable, and their accuracy is proven with external data sets. To date, many scoring systems have been proposed for early determination of stroke severity. Although the most accepted and widely used system among these systems is the National Institute of Health Stroke Scale (NIHSS), the need for training and experience for practitioners and the time-consuming application restrict its use in pre-hospital or emergency department triage. Alternatively, short and easily applicable systems such as The Los Angeles Motor Scale (LAMS), The Cincinnati Prehospital Stroke Scale (CPSS), Rapid Arterial oCclusion Evaluation (RACE) have been developed in the pre-hospital setting. However, the inability of these systems to provide high sensitivity and specificity together has necessitated the development of other alternative scoring systems. Among the new scoring systems developed in recent years, the Vision, Aphasia, and Neglect (VAN) score, the Ventura Emergency Large Vessel Occlusion (VES) score, and the Large Artery Intracranial Occlusion Stroke Scale (LARIO) have shown high diagnostic performance in pilot studies. The VAN score was shown to be 100% sensitive and 90% specific in predicting large vessel occlusion in stroke patients with motor weakness accompanied by at least one of the symptoms of vision, aphasia, and neglect or an NIHSS score of >6. The VES score was developed as a 4-step system evaluating eye deviation, aphasia, neglect, and lethargy, and it was reported that the presence of at least one of these functions was 95% sensitive and 82% specific in predicting large vessel occlusion. The LARIO score was developed as a 5-step system evaluating facial paralysis, speech disorder, arm weakness, hand grip weakness, and neglect. Having >3 of these steps positive provided 100% sensitivity and 82% specificity for large vessel occlusion. The results obtained from pilot studies suggest that the use of VAN, VES, and LARIO scoring systems in pre-hospital or emergency department triage promises to improve neurological outcomes by early identification of patients with large vessel occlusion requiring MT, appropriate triage, and optimal application of stroke protocols
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Positive VAN scale | – | Diagnostic Test: VAN assessmentMotor Function: Check for arm drift with arms extended, palms up, and eyes closed for 10 seconds. If present, proceed to the VAN criteria. V (Visual): Assess for reported double vision, field cut, or vision loss, or difficulty seeing fingers in a quadrant. If any visual disturbances are found, the patient is "VAN positive". A (Aphasia): Identify difficulties forming words, repeating a short sentence, recognizing two objects, or following simple commands. If any aphasia symptoms are observed, the patient is "VAN positive". N (Neglect): Check for forced gaze, inability to track a pen to one side, or lack of sensation in limbs. If any neglect signs are detected, the patient is "VAN positive". |
| Negative VAN scale | – | Diagnostic Test: VAN assessmentA negative VAN scale indicates that a potential stroke patient does not exhibit the primary signs associated with a large vessel occlusion (LVO). Specifically, the patient demonstrated no arm drift during the initial motor function test. If the motor assessment is proceeded to the VAN criteria, the patient shows no visual disturbances like double vision or field cuts ("V"), no aphasia symptoms such as difficulty forming words or repeating sentences ("A"), and no signs of neglect, like forced gaze or lack of sensation in limbs ("N") |
| Positive VES scale | – | Diagnostic Test: VES assessmentEye Deviation: Scored as 1 if there's a forced deviation of both eyes to any side; otherwise, scored as 0. Aphasia: Scored as 1 if the patient is awake and exhibits one or more of the following: Inability to repeat a sentence. Inability to name an object. Talking incoherently or not obeying commands. Being mute. Otherwise, scored as 0. Neglect: Scored as 1 if the patient can perceive touch on both sides individually but fails to feel it on one side when stimulated simultaneously. Otherwise, scored as 0. Obtundation: Scored as 1 if the patient cannot maintain wakefulness during a conversation; otherwise, scored as 0. The VES can range from 0 to 4. A score of 1 or higher suggests a positive likelihood for ELVO. Additionally, if a patient tests positive for aphasia, neglect can be deduced by noting if the patient disregards the examiner on one side but is responsive when the examiner switches sides. |
| Negative VES scale | – | Diagnostic Test: VES assessmentEye Deviation: No forced deviation of both eyes is observed. Aphasia: The patient, while awake, can repeat sentences, name objects, speaks coherently, follows commands, and is not mute. Neglect: The patient can perceive touch both when sides are stimulated individually and simultaneously. Obtundation: The patient remains awake and alert during conversation. A total score of 0 on the VES scale represents a VES negative outcome. |
| Positive LARIO scale | – | Diagnostic Test: LARIO assessmentFacial Palsy: The presence of facial muscle weakness or paralysis scores 1, while a normal facial expression scores 0. Arm Weakness: A score of 1 is given for arm drift, no effort against gravity, or no movement at all. No drift is scored 0. Grip Strength: Reduced or absent grip strength scores 1, while a normal grip scores 0. Language: Changes in speech, global aphasia, or the patient being mute results in a score of 1. Normal language is scored 0. Neglect: A score of 1 is given if the patient exhibits extinction to bilateral simultaneous stimulation in one or more sensory modality, doesn't recognize their own hand, or consistently orients only to one side of the body. The absence of these signs scores 0. A cumulative score exceeding 3 on the LARIO Stroke Scale categorizes the patient as "LARIO positive," |
| Negative LARIO scale | – | Diagnostic Test: LARIO assessmentFacial Palsy: No observable facial muscle weakness or paralysis. Arm Weakness: The arm remains steady without drift and exhibits normal effort against gravity. Grip Strength: The patient displays normal grip strength. Language: The patient speaks normally, without aphasia or muteness. Neglect: No signs of sensory extinction upon bilateral simultaneous stimulation, proper recognition of their own hand, and balanced orientation to both sides of the body. A cumulative score of 3 or less on the LARIO Stroke Scale classifies the patient as "LARIO negative," |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients with a suspicion of stroke who were admitted to the ED by EMS.
Key inclusion criteria (1 listed)
- Adult patients admitted to the ED with the suspicion of stroke by EMS.
Key exclusion criteria (7 listed)
- More than 24 hours have passed since the onset of symptoms or the last known normal in the patient.
- The emergency physician does not indicate the need for imaging like Computerized Tomography (CT), CT Angiography (CTA), Diffusion-Weighted Magnetic Resonance Imaging (DWI-MRI), or Magnetic Resonance Angiography (MRA), or the imaging test cannot be performed.
- Exacerbation of residual symptoms due to a previous hemorrhagic or ischemic stroke.
- Conditions in the ED that prevent scale assessment (e.g., advanced airway needs, the patient's non-cooperation with the examination, immediate resuscitation need, etc.).
- Patients transferred to ED after being diagnosed at another healthcare institution.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAN assessmentAn investigator assesses the VAN scale when a patient arrives at ED triage with a suspected stroke. | Diagnostic test | Negative VAN scale, Positive VAN scale |
| VES assessmentAn investigator assesses the VES scale when a patient arrives at ED triage with a suspected stroke. | Diagnostic test | Negative VES scale, Positive VES scale |
| LARIO assessmentAn investigator assesses the LARIO scale when a patient arrives at ED triage with a suspected stroke. | Diagnostic test | Negative LARIO scale, Positive LARIO scale |
Primary outcome
Diagnostic performance of VAN for predicting ELVO
Time frame: 24 hours
Sensitivity, specificity, PPV, NPV
Diagnostic performance of VES for predicting ELVO
Time frame: 24 hours
Sensitivity, specificity, PPV, NPV
Diagnostic performance of LARIO for predicting ELVO
Time frame: 24 hours
Sensitivity, specificity, PPV, NPV
1 secondary outcome
Diagnostic performance of NIHSS for predicting ELVO
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of VAN for predicting ELVO (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.