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NCT05283850 · ClinicalTrials.gov registry record · Phase 2

Surviving PEA in Roanoke (SPEAR) Study

A Phase 2 study of Cardiac Arrest and Pulseless Electrical Activity, sponsored by Carol Bernier.

Recruiting
Registry status
Phase 2
Development phase
342
Enrollment target
1
Study location

NCT05283850: Recruiting Phase 2 study of Cardiac Arrest and Pulseless Electrical Activity, sponsored by Carol Bernier.

NCT05283850 is a Phase 2 study of Cardiac Arrest and Pulseless Electrical Activity that is actively recruiting participants, run by Carol Bernier. The registered enrollment target is 342 participants, below the 1,469-participant average among 31 other Cardiac Arrest trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05283850, a Phase 2 study of Cardiac Arrest and Pulseless Electrical Activity, is actively recruiting participants, sponsored by Carol Bernier.

RECRUITING
Registry status
Phase 2
Development phase
342 participants
Enrollment target
1
Study location

Study Summary

The Carilion Clinic and Virginia Tech Carilion School of Medicine, in conjunction with Roanoke Fire-EMS, Botetourt County Department of Fire \& EMS and Salem Fire-EMS, are studying the outcomes of patients experiencing Pulseless Electrical Activity (PEA). PEA refers to a type of cardiac arrest in which there is normal electrical activity in the heart however the heart still fails to contract to generate a pulse. Without heart contractions, which normally generates a pulse, the brain and other important organs fail to receive blood and oxygen. Unfortunately, the majority (97.3%) of patients that experience this rhythm do not survive and most don't even make it to the hospital. This study is trying to determine if the administration of a High Calcium, Low Sodium (HCLS) fluid in pre-hospital care will improve the chances of survival. Generally, a sodium (salt) solution is provided to patients experiencing cardiac arrest. Studies have shown that lower sodium and higher calcium content may activate certain parts of the heart cells required to generate a pulse under PEA conditions. This study is a double-blind, prospective, clinical trial. PEA patients will randomly receive either routine fluid therapy (salt solution) or a HCLS solution. While HCLS solution is not the standard fluid used by EMS providers responding to PEA, it is composed of FDA approved components and is occasionally used by EMS providers at their discretion in treating PEA. It is predicted that HCLS will either improve PEA survival or deliver similar outcomes as routine treatment. All patients will receive standard, high quality cardiac arrest and post-cardiac arrest care regardless of assigned treatment group.

Primary Outcome

ROSC sustained until arrival at the emergency department and transfer of care to medical staff at the receiving hospital?

Conditions Studied

Cardiac Arrest Pulseless Electrical Activity

Interventions

  • DRUG High Calcium, Low Sodium (HCLS) Crystalloid Therapy
  • DRUG High Calcium, High Sodium (HCHS) Crystalloid Therapy

Study Locations (1)

Virginia

  • Carilion Clinic - Roanoke

Trial Details

FieldValue
Enrollment Target 342 participants
Start Date 2022-02-16
Est. Completion 2027-02
Phase Phase 2
Carol Bernier

1 total trials

What NCT05283850 shows while recruiting

NCT05283850 is an interventional study that assigns participants to a tested intervention. The registered 342 participants enrollment target is mid-sized for trials with a published cap, below the 1,469-participant average among 31 other Cardiac Arrest trials with a reported enrollment target (77% lower).

The record links to 2 conditions, with Cardiac Arrest appearing as the primary indexed condition, and to 2 interventions - of which High Calcium, Low Sodium (HCLS) Crystalloid Therapy is the first listed.

NCT05283850 reports a single indexed study location in Virginia.

Frequently Asked Questions

What is clinical trial NCT05283850 about?

NCT05283850 is a clinical study titled "Surviving PEA in Roanoke (SPEAR) Study". The Carilion Clinic and Virginia Tech Carilion School of Medicine, in conjunction with Roanoke Fire-EMS, Botetourt County Department of Fire \& EMS and Salem Fire-EMS, are studying the outcomes of patients experiencing Pulseless Electrical Activity (PEA). PEA refers to a type of cardiac arrest in wh...

What is the current status of trial NCT05283850?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 342 participants. The study started on 2022-02-16. Estimated completion is 2027-02.

What conditions does trial NCT05283850 study?

This clinical trial studies the following conditions: Cardiac Arrest, Pulseless Electrical Activity.

What interventions are being tested in trial NCT05283850?

The interventions under investigation include: High Calcium, Low Sodium (HCLS) Crystalloid Therapy (DRUG), High Calcium, High Sodium (HCHS) Crystalloid Therapy (DRUG).

Who is sponsoring clinical trial NCT05283850?

This trial is sponsored by Carol Bernier, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05283850 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Cardiac Arrest

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05283850's enrollment target sits among peer trials

342 12th of 31 higher than 20 of 31 other Cardiac Arrest trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cardiac Arrest trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05283850

Source: ClinicalTrials.gov NCT05283850, the US trial registry maintained by the National Library of Medicine. NCT05283850 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.