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NCT05958342From ClinicalTrials.govRecruiting

CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial

  • Trauma
  • Hemorrhage

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Jason Sperry
Enrolment target
1,050
Started
30 June 2024
Main results due
March 2027
Study sites
18
Registry updated
29 September 2026

Can you take part?

  • Ages 18 years to 90 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

Prehospital Phase:

Injured patients at risk of hemorrhagic shock being transported from scene or referral hospital to a participating CAVALIER trial site who meet the following criteria:

1A. Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital, or during anticipated transport to a participating CAVALIER trial site

OR

1B. Systolic blood pressure ≤ 70mmHg at scene, at outside hospital, or during anticipated transport to a participating CAVALIER trial site

Early In-Hospital Phase:

Injured patients at a participating CAVALIER trial site at risk of hemorrhagic shock who meet the following criteria:

1A. Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital, during transport, or in emergency department of a participating CAVALIER trial site

OR

1B. Systolic blood pressure ≤ 70mmHg at scene, at outside hospital, during transport, or in emergency department of a participating CAVALIER trial site

AND

2.Blood/blood component transfusion initiated in prehospital setting or deemed clinically indicated within 60 minutes of arrival at the enrolling trauma center

AND 3. Clinical team deems Operating Room for major hemorrhage control procedure (e.g., laparotomy, thoracotomy, vascular exploration or extremity amputation) indicated within 60 minutes of arrival at the enrolling trauma center

AND

4\. Anticipated admission to intensive care unit (ICU)

Exclusion Criteria:

Prehospital Phase

1. Wearing NO CAVALIER opt-out bracelet
2. Age \> 90 or \< 18 years of age
3. Isolated fall from standing injury mechanism
4. Known prisoner
5. Known pregnancy
6. Traumatic arrest with \> 5 minutes of CPR without return of vital signs
7. Brain matter exposed or penetrating brain injury
8. Isolated drowning or hanging victims
9. Objection to study voiced by subject or family member at the scene or at the trauma center
10. Inability to obtain IV/IO access

Early In-Hospital Phase:

1. Wearing NO CAVALIER opt-out bracelet
2. Age \> 90 or \< 18 years of age
3. Isolated fall from standing injury mechanism
4. Known prisoner
5. Known pregnancy
6. Traumatic arrest with \> 5 minutes of CPR without return of vital signs
7. Brain matter exposed or penetrating brain injury
8. Isolated drowning or hanging victims
9. Objection to study voiced by subject or family member at the scene or at the trauma center
10. Inability to obtain IV access

What this study is about

In the sponsor’s own words, from the registry.

The CAlcium and VAsopressin following Injury Early Resuscitation (CAVALIER) Trial is a proposed 4 year, double-blind, mutli-center, prehospital and early in hospital phase randomized trial designed to determine the efficacy and safety of prehospital calcium and early in hospital vasopressin in patients at risk of hemorrhagic shock.

Study sites(18)

  • Chandler Regional Medical Center

    Chandler, Arizona, United States

    Recruiting

  • University of Arizona

    Tucson, Arizona, United States

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States

    Recruiting

  • Zuckerberg San Francisco General Hospital and Trauma Center at University of California, San Francisco

    San Francisco, California, United States

    Recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, United States

    Recruiting

  • Denver Health Medical Center

    Denver, Colorado, United States

    Recruiting

  • University of Miami

    Miami, Florida, United States

    Recruiting

  • University of Maryland, Baltimore

    Baltimore, Maryland, United States

    Recruiting

  • Hennepin County Medical Center

    Minneapolis, Minnesota, United States

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, United States

    Recruiting

  • University of Missouri Health Care

    Columbia, Missouri, United States

    Recruiting

  • University of New Mexico

    Albuquerque, New Mexico, United States

    Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, United States

    Recruiting

  • Mount Carmel East Hospital

    Columbus, Ohio, United States

    Recruiting

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, United States

    Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, United States

    Recruiting

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, United States

    Recruiting

  • University of Washington Harborview Medical Center

    Seattle, Washington, United States

    Recruiting

Showing 18 of 18 sites. 18 of the 18 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05958342. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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