Surviving PEA in Roanoke (SPEAR) Study
Launched by CAROL BERNIER · Mar 8, 2022
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
The SPEAR Study is a clinical trial being conducted by the Carilion Clinic and Virginia Tech Carilion School of Medicine, along with local fire and emergency services, to investigate how to better treat patients experiencing a specific type of cardiac arrest called Pulseless Electrical Activity (PEA). In PEA, the heart has normal electrical activity but fails to pump blood, which can lead to severe consequences since the brain and other vital organs don’t get the blood and oxygen they need. Unfortunately, most patients with PEA do not survive. This study aims to see if using a special fluid with high calcium and low sodium (HCLS) can improve survival rates compared to the usual salt solution that is typically given.
Patients aged 18 and older who experience PEA while being treated by the involved emergency services may be eligible to participate in the study. Participants will be randomly assigned to receive either the new HCLS fluid or the standard treatment, but all will still receive high-quality care for their cardiac arrest. It’s important to note that certain individuals, such as those with specific medical conditions or a Do Not Resuscitate order, will not be included in the trial. Overall, this study hopes to find a better way to help patients during a critical time when every moment counts.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • All patients who present with PEA at any time during the patients' treatment by Roanoke Fire-EMS, Botetourt County Department of Fire \& EMS and/or Salem Fire-EMS. This study defines a PEA presentation as any patient who is unconscious, presenting without a carotid pulse and with non-(VT/VF) ventricular tachycardia/ventricular fibrillation electrical activity.
- Exclusion Criteria:
- • Patient less than 18 years old
- • Known pregnancy
- • Duration of untreated cardiac arrest of more than 30 minutes
- • Traumatic cardiac arrest
- • Known (LVAD) Left Ventricular Assist Device
- • Rapidly fatal underlying disease
- • Known or suspected digitalis toxicity
- • A physical, durable (DNR) Do Not Resuscitate (or durable DNR medical jewelry) presented to EMS before treatment with asserting a preference not to be enrolled
- • Prisoners and other populations with involuntary consent
About Carol Bernier
Carol Bernier is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes. With a focus on innovative therapies and evidence-based practices, Ms. Bernier leads initiatives that facilitate the design, oversight, and execution of clinical trials across various therapeutic areas. Her extensive experience in trial management and regulatory compliance ensures that studies are conducted with the highest standards of ethics and scientific rigor. Passionate about collaboration, she fosters partnerships with healthcare professionals, research institutions, and patient advocacy groups to drive successful trial outcomes and contribute to the development of new treatment options.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roanoke, Virginia, United States
Patients applied
Trial Officials
Carol Bernier, DO
Principal Investigator
Virginia Polytechnic Institute and State University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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