What side effects are associated with this type of intervention?

Common treatments for stroke, particularly those involving the diagnosis and management of intracerebral hemorrhage (ICH), include thrombolytic therapy, anticoagulants, and mechanical thrombectomy. Thrombolytic therapy, such as the use of tissue plasminogen activator (tPA), can lead to bleeding complications, including hemorrhagic transformation of the ischemic stroke. Anticoagulants, used to prevent clot formation, carry a risk of bleeding and hemorrhage. Mechanical thrombectomy, a procedure to remove a blood clot from a large artery, can result in complications such as vessel damage, bleeding, and, in rare cases, stroke recurrence. These treatments aim to restore blood flow or prevent further clotting but must be carefully managed to balance efficacy and safety.

What prior FDA approvals exist?

The FDA has approved several treatments for stroke, particularly focusing on thrombolytic agents like alteplase (tPA), which is used to dissolve clots in ischemic stroke. While there are no specific FDA approvals for portable ultrasound technology (cPOCUS) used by EMS for diagnosing brain hemorrhage, transcranial ultrasound has been studied for its potential in monitoring and guiding thrombolytic therapy. This technology can help in real-time assessment of cerebral blood flow and clot dissolution, which is crucial in acute stroke management.

What other types of research exist?

Promising novel alternatives to cPOCUS for stroke patients in 2024 include: 1) Noninvasive ICP assessment techniques, which are being developed to improve accuracy and reliability. 2) Fiberoptic intraparenchymal cerebral pressure monitors, which provide continuous and reliable ICP data with low complication rates. 3) Advanced ultrasound-based techniques, which are being refined for better accuracy in assessing intracranial conditions. These alternatives aim to enhance diagnostic capabilities while minimizing invasiveness.

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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 below

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I am 18 years old or older.

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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:

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I am under 18 years old.

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I have had a serious head injury or scalp wound.

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Ultrasound procedures are not suitable for my care.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 1 for reporting.

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

0 / 6Eligibility criteria met

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.