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Ultrasound
Portable Ultrasound for Stroke Diagnosis (CUPID_EMS Trial)
N/A
Waitlist Available
Led By Aarti Sarwal, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years old or older
Transfer initiated by EMS to the ED for further evaluation
Must not have
Less than 18 years old
Penetrating cranial/head trauma or scalp wound
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 1
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if EMS personnel can use portable ultrasound to quickly diagnose brain bleeding in stroke patients by sending images to a remote doctor for interpretation.
Who is the study for?
This trial is for adults who EMS providers think might be having a stroke or brain hemorrhage, and are being taken to the emergency department. It's not for people under 18, prisoners, those with head injuries from penetration or scalp wounds, or if an ultrasound could interfere with their care.
What is being tested?
The study is testing whether paramedics can use a portable ultrasound device (cPOCUS) on the way to the hospital to diagnose acute bleeding inside the brain (ICH).
What are the potential side effects?
There are generally no side effects associated with cranial point of care ultrasounds as they are non-invasive imaging tests. However, there may be discomfort due to pressure from the ultrasound probe.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I was brought to the emergency department by ambulance for further checks.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18 years old.
Select...
I have had a serious head injury or scalp wound.
Select...
Ultrasound procedures are not suitable for my care.
Select...
I choose not to go to the emergency department.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Success Rate for cPOCUS Exams
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cranial Point of Care UltrasoundExperimental Treatment1 Intervention
Cranial ultrasound involves 2-dimensional B mode imaging of the brain parenchyma in the axial plane
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cranial Point of Care Ultrasound
2022
N/A
~90
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for stroke, particularly ischemic stroke, include thrombolytics like tissue plasminogen activator (tPA), which works by dissolving blood clots to restore blood flow to the brain. For hemorrhagic stroke, treatments focus on controlling bleeding and reducing intracranial pressure, often involving medications like antihypertensives and surgical interventions such as craniotomy.
The use of cPOCUS by EMS can rapidly diagnose ICH, allowing for quicker decision-making and appropriate treatment initiation, which is crucial for improving outcomes and reducing long-term disability in stroke patients.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,397 Previous Clinical Trials
2,460,049 Total Patients Enrolled
17 Trials studying Stroke
14,539 Patients Enrolled for Stroke
Aarti Sarwal, MDPrincipal InvestigatorWake Forest University Health Sciences
4 Previous Clinical Trials
1,295 Total Patients Enrolled
1 Trials studying Stroke
200 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I have had a serious head injury or scalp wound.I am 18 years old or older.Ultrasound procedures are not suitable for my care.If a patient is suspected of having a stroke or a brain hemorrhage by the Emergency Medical Services (EMS) provider and is being taken to the nearest Emergency Department (ED) for evaluation, they can join the study.I choose not to go to the emergency department.I was brought to the emergency department by ambulance for further checks.Using ultrasound won't affect my routine care.